AFFY zu Recht abgestraft? - 500 Beiträge pro Seite

[MrRipley]

Heute wird gemeldet, dass ihnen Takeda 30 Millionen zahlt für eine pharmazeutische Entwicklung. Gestern noch gab es einen Kurssturz von ca 70%:





Shares of $180 million (market cap) biotech Affymax (AFFY) are plunging a whopping $14.87, or 65%, $8.13, after the company this morning announced results of Phase III trials for a drug under development called “Hematide,” for treating anemia, that seemed to cast doubt on the likelihood of FDA approval of the drug.

Raj Mehra of Auriga Securities, downgrading the shares to “Hold” from “Buy” this morning wrote that “The released data certainly puts the approval of Hematide in doubt at the moment, especially given the fact that Epogen and Aranesp (both of Amgen (AMGN) are) have adequately addressed the needs of the patients over the years.”

Mehra set a new $9 price target, based on a multiple of two times his projected year-end cash balance of $4.50 per share for AFFY.

[MrRipley]

[santandor]

Antwort auf Beitrag Nr.: 39.721.802 von MrRipley am 22.06.10 19:19:21

Wie kommt der Kurssturz zustande? Gibts da infos zu? Meinungen?

[Tommi33]

Antwort auf Beitrag Nr.: 39.797.805 von santandor am 09.07.10 09:57:45

Einfach mal hier nachlesen -> http://seekingalpha.com/article/213587-affymax-sell-off-did-…

So wie ich es verstanden habe sollen sie eine PR rausgebracht haben die vom Markt fürchterlich missverstanden wurde.

LG Tommi

[santandor]

Antwort auf Beitrag Nr.: 39.799.002 von Tommi33 am 09.07.10 12:45:45

Wenn das so ist wird es ja in der nächsten Zeit tierisch schäppern hier wenn alle wieder rein wollen und sich selbst in den Arsch beissen weil sie raus gestürmt sind...

[Tommi33]

Affymax to Webcast Analyst Briefing on Hematide™/Peginesatide Development Program

PALO ALTO, Calif.--(BUSINESS WIRE)-- Affymax, Inc. (NASDAQ:AFFY) today announced it will host an analyst briefing on Thursday, December 2, 2010 at 9:00 a.m. ET.

Affymax management will provide clinical, regulatory and commercial updates on Hematide™/peginesatide. There will also be a featured presentation by Dr. Steven Fishbane, lead investigator on the Phase 3 program and chief medical officer of Winthrop-University Hospital and chief of the division of Nephrology and medical director of Winthrop's Dialysis Network.

The live webcast, to begin at 9:00 a.m. ET, may be accessed from the investors section of the company's website at www.affymax.com. A replay will also be available for 30 days following the presentation.

About Hematide™/peginesatide

Peginesatide is a novel investigational synthetic, PEGylated peptidic compound that binds to and activates the erythropoietin receptor and thus acts as an ESA.

Affymax and Takeda are collaborating on the development of peginesatide and plan to co-commercialize the product once approved in the United States. Phase 3 clinical trials investigated the potential for peginesatide to treat anemia associated with chronic renal failure. The product, upon approval, will be commercialized outside the United States by Takeda.

About Affymax, Inc.

Affymax, Inc. is a biopharmaceutical company committed to developing novel drugs to improve the treatment of serious and often life-threatening conditions. For additional information, please visit www.affymax.com.

Affymax, Inc.
Sylvia Wheeler, 650-812-8861
Vice President, Corporate Communications

Source: Affymax, Inc. http://www.investors.affymax.com/releasedetail.cfm?ReleaseID…

News Provided by Acquire Media

[Tommi33]

Affymax to Present at Piper Jaffray 22nd Annual Health Care Conference



PALO ALTO, Calif.--(BUSINESS WIRE)-- Affymax, Inc. (Nasdaq: AFFY) today announced that Arlene Morris, the company's chief executive officer, will present at the Piper Jaffray 22nd Annual Health Care Conference on Wednesday, December 1, 2010, at 2:00 p.m. Eastern time (11:00 a.m. Pacific time) at The New York Palace Hotel in New York City.

A live webcast of the presentation will be available on the investors section of the Company's website at www.affymax.com. A replay will also be available for 30 days following the presentation.

About Affymax, Inc.

Affymax, Inc. is a biopharmaceutical company committed to developing novel drugs to improve the treatment of serious and often life-threatening conditions. For additional information, please visit www.affymax.com.



Source: Affymax, Inc.




Read more: http://www.nasdaq.com/aspx/company-news-story.aspx?storyid=2…

[Tommi33]

http://seekingalpha.com/article/239628-silver-lining-for-aff…

LG Tommi

[Tommi33]

Affymetrix Announces Court Order Directing Dismissal of Illumina Patent Infringement Lawsuits

SANTA CLARA, Calif., Dec 15, 2010 (BUSINESS WIRE) --

Affymetrix, Inc. (NASDAQ:AFFX) (the "Company") today announced that the U.S. District Court for the Western District of Wisconsin (the "Court") has granted the company's motion for summary judgment that Affymetrix does not infringe the patents held by Illumina, Inc. (NASDAQ: ILMN), and has directed that the patent infringement lawsuits brought against the company by Illumina regarding U.S. Patent Nos. 7,510,841 and 7,612,020 be dismissed and the cases closed.

"We are pleased with the Court's ruling, which confirms our position that Illumina's lawsuits were without merit," said Rick Runkel, Affymetrix's Executive Vice President, General Counsel and Secretary. "As a biotechnology company that invests significant time, resources and expertise in R&D, we are committed to conducting our business with the utmost integrity and believe that the Court's ruling underscores this commitment."

About Affymetrix

Affymetrix technology is used by the world's top pharmaceutical, diagnostic, and biotechnology companies, as well as leading academic, government, and nonprofit research institutes. More than 1,900 systems have been shipped around the world and more than 22,000 peer-reviewed papers have been published using the technology.

Affymetrix is headquartered in Santa Clara, Calif., and has manufacturing facilities in Cleveland, Ohio, and Singapore. The company has about 1,000 employees worldwide and maintains sales and distribution operations across Europe and Asia. For more information about Affymetrix, please visit http://www.affymetrix.com.

http://phx.corporate-ir.net/phoenix.zhtml?c=116408&p=irol-ne…

[Tommi33]

Event Details

Title Affymetrix at JP Morgan HealthCare Conference
Date and Time Thursday, January 13, 2011 7:30 a.m. PT
Duration 1 Hour
Location San Francisco, CA

http://phx.corporate-ir.net/phoenix.zhtml?c=116408&p=irol-Ev…

[Tommi33]

Affymetrix Partners With Fisher Scientific to Expand Markets for the World's First Personal Microarray System
The GeneAtlas System gains the power of the Fisher Scientific premier customer channel

SANTA CLARA, Calif., Jan 12, 2011 (BUSINESS WIRE) --

Affymetrix, Inc. (NASDAQ:AFFX) today announced that it has signed a distribution agreement with Fisher Scientific, Inc., part of Thermo Fisher Scientific, to distribute the GeneAtlas(TM) System and its related consumables through the Fisher Scientific channel throughout the United States and Canada. The GeneAtlas System is the first personal microarray solution to meet the demand among life scientists for an easy to use and affordable way to interrogate the whole genome. Fisher Scientific has a leading position in the life sciences market and provides an unparalleled reach and a proven record of customer service and support.

"We are excited to reach this agreement with Fisher Scientific because it allows us to expand our commercial sales in research markets while maintaining our focus further downstream in validation and clinical markets," said Andy Last, Chief Commercial Officer at Affymetrix. "Now we have a partner with the industry's strongest customer channel to take this technology to the broadest life scientist community, which is key to the GeneAtlas System's success."

The strategic partnership will bring the superior microarray technology of Affymetrix to every lab, putting whole-genome analysis into the hands of every researcher who has been limited by budget and inhibited by the complexity of microarray systems. Life scientists will no longer be forced to use less powerful technologies; settling for a limited view of the genome will become a thing of the past.

"We are also excited to be entering into this relationship with Affymetrix; it broadens our extensive genomic research portfolio and allows us to offer a full suite of solutions from discovery research through to validation," said Dan Pantano, President of Fisher Scientific. "By partnering with the industry innovator and pioneer in microarray technology it provides Fisher Scientific an opportunity to offer customers a premium option when faced with challenging genomic research, and the GeneAtlas System is the perfect solution for many customers we routinely serve," Pantano added.

At a never-before-seen price for a complete microarray analysis solution, the GeneAtlas System allows researchers to take control of their samples and accelerate their pace to results and publication. The easy-to-use bench top design provides a complete end-to-end solution for processing the industry's most widely cited gene expression arrays and analyzing biological pathways. With integrated data analysis designed for biologists, not bioinformaticians, and wizard-driven statistical and pathway analysis, life scientists are only nine clicks away from data to pathways when using the GeneAtlas System, the simplest microarray workflow available.

http://investor.affymetrix.com/phoenix.zhtml?c=116408&p=irol…

[Tommi33]

Affymetrix Announces Positive Operating Income and Net Income for Q4-2010
- Total revenue for the fourth quarter of approximately $85 million -

SANTA CLARA, Calif., Jan 12, 2011 (BUSINESS WIRE) --

Affymetrix, Inc. (NASDAQ:AFFX) today announced that based on preliminary financial data, the Company expects to generate positive operating income and net income on a GAAP basis for the fourth-quarter of 2010. Total revenue for the fourth quarter is expected to be approximately $85 million and includes a $4.8 million milestone payment from a "Powered by Affymetrix" diagnostic partner.

The Company also announced that it has repurchased an additional $53 million face value of 3.5% convertible notes. The Company repurchased more than $150 million of 3.5% convertible notes in 2010 and now has about $95 million in outstanding convertible debt. The Company expects to have a year-end net cash balance of approximately $140 million.

"We made significant progress in 2010 and we expect to report positive operating income and net income for both the fourth quarter and the second half of 2010," said Kevin M. King, president and chief executive officer. "These results reflect our disciplined focus on operations which has significantly lowered our break-even point. We exit 2010 in a strong financial position and we are committed to the continued improvement of our business in 2011 and beyond."

Affymetrix will webcast its presentation at the 29th Annual JP Morgan Healthcare Conference on Thursday, January 13, 2011 at 7:30 a.m. PT. A live webcast will be available at http://www.affymetrix.com under the "Investors" link. The archived webcast will be available for 30 days.

Affymetrix' management team will host a conference call on February 2, 2011 at 2:00 p.m. PT to review its operating results for the fourth quarter and fiscal year 2010. A live webcast can be accessed by visiting the Investor Relations section of the Company's website at www.affymetrix.com. In addition, investors and other interested parties can listen by dialing domestic: [phone], international: [phone].

A replay of this call will be available from 5:00 p.m. PT on February 2, until 8:00 p.m. PT on February 9, 2011 at the following numbers: domestic: [phone], international: [phone]. The passcode for both replays is 364850. An archived webcast of the conference call will be available under the Investor Relations section of the Company's website.

http://investor.affymetrix.com/phoenix.zhtml?c=116408&p=irol…

[Tommi33]

Affymetrix Launches Cost-Effective Bovine Genotyping Array for Accurate Trait Selection
Axiom(TM) array solution provides breeders with the highest genetic coverage in the industry

SANTA CLARA, Calif., Jan 12, 2011 (BUSINESS WIRE) --

Affymetrix, Inc. (NASDAQ:AFFX) today announced it has launched the Axiom(TM) Genome-Wide BOS 1 Array, which has 34 percent higher genetic coverage than the current leading array because of its unique design. Developed in conjunction with the Affymetrix Bovine Consortium of leading breeders and researchers worldwide, the array comprehensively covers genetic traits from the most commercially vital breeds of dairy and beef cattle. The Axiom Genome-Wide BOS 1 Array's high-performing markers greatly improve the reliability of genetic profiling by giving breeders an accelerated path to higher quality beef and dairy cattle and reducing the need for costly and time-consuming phenotypic testing.

The Affymetrix Bovine Consortium, including the University of Missouri, U.S. Department of Agriculture's Agricultural Research Service (USDA-ARS), Roslin Institute and ARK-Genomics, University of Edinburgh, Technical University of Munich, and University of Liverpool, among others, sequenced genomic DNA from a variety of Bos taurus and Bos indicus breeds, including Holstein, Angus, Nelore, and Gir, to discover 46 million potential single nucleotide polymorphisms (SNPs). Approximately 400 samples from 20 diverse breeds were used to screen millions of these SNPs to identify 3 million high-performing, validated polymorphic SNPs. Finally, a subset of more than 648,000 SNPs was selected using a novel array design process that maximizes genetic coverage and minimizes redundancy for cost-effective genotyping.

"We're proud to be a part of a highly successful collaboration and that our new genetic profiling application will generate enormous value for breeders in terms of expense and time savings," said Kevin King, Affymetrix President and CEO. "We're hearing from our collaborators that our array is setting a new standard for cattle genotyping because it supplies what other options lack--maximum genetic coverage for an affordable price."

Three million validated SNPs comprise the newly launched Axiom Bovine Genomic Database, which has supplied many Affymetrix Bovine Consortium members with data obtained from their samples. Now, the database is available to all breeders and researchers who also want to design their own customized arrays through the Axiom myDesign(TM) Genotyping Array service.

Neogen Corporation's (NASDAQ:NEOG) subsidiary GeneSeek(R), a global provider of DNA testing for farm animal improvement and veterinary diagnostic testing and surveillance, will be among the first to offer Axiom Genotyping Solution services to the bovine community using the GeneTitan(R) System.

"Since 1998, GeneSeek has been providing comprehensive solutions and services for the agricultural biotechnology industry," said Andy Last, Chief Commercial Officer at Affymetrix. "We are excited to see GeneSeek evaluating our platform to better serve its worldwide customers who are increasingly seeing the importance of using genotyping in their breeding process."

http://investor.affymetrix.com/phoenix.zhtml?c=116408&p=irol…

[Tommi33]

Affymetrix Provides Highest Density Rice Genotyping Array for Identifying Unique Genetic Traits
Affymetrix rice consortium partners' research may lead to improving rice production

SANTA CLARA, Calif., Jan 14, 2011 (BUSINESS WIRE) --

Affymetrix, Inc. (NASDAQ:AFFX) today announced at the Plant and Animal Genome XIX Conference (PAG) that it launched the GeneChip(R) Rice 44K SNP Genotyping Array, the first high-density rice genotyping array. This array was designed in collaboration with a worldwide community of rice researchers to improve the rice industry's production confidence by providing a low-cost, high-quality method for reliably identifying rice varietals and examining the genetic inheritance of important agricultural traits.

The GeneChip Rice 44K SNP Genotyping Array was developed in collaboration with Dr. Susan D. McCouch, Professor in the Department of Plant Breeding and Genetics at Cornell University, as well as a team of scientists from world-renowned rice research institutes and private sector partners. The array features more than 44,000 SNPs and detects common genetic variants within and between the major subpopulations of O. sativa, including indica, aus, tropical japonica, temperate japonica, and aromatic, or Group V.

"Our aim was to design an array dense enough to conduct genome-wide association mapping studies and with the power to find genes or loci underlying most phenotypes," said Dr. McCouch. "The beauty of Affymetrix' Rice 44K SNP Genotyping Array is that it enables us to explore quality and performance characteristics of rice varieties all over the world, many of which are not well known. Now their genomes are accessible." Dr. McCouch will be presenting her work at the PAG conference in San Diego.

With the Rice 44K SNP Genotyping Array, rice breeders for the first time will be able to efficiently and cost-effectively classify their germplasm as well as track and fingerprint varieties for improved seed management, property protection, and patents. To provide the rice community with access to this powerful technology, Affymetrix has designated service providers who offer quality assurance, quick turnaround time, affordable prices, and confidentiality to researchers.

"We are pleased to have DNA Landmarks and Expression Analysis on board as our service providers to conduct this important service for the rice research community worldwide," said Andy Last, Chief Commercial Officer at Affymetrix. "This will quicken the discovery of natural variation and quality characteristics impacting rice production, which experts say must increase to keep pace with the world's growing population."

The rice community's project team, led by Dr. McCouch, also included groups from the USDA's Agricultural Research Service (ARS), the National Rice Research Center in Stuttgart, Arkansas, Stanford University's Department of Genetics in Stanford, California, and the International Rice Research Institute (IRRI) in Los Banos, Philippines. The project was funded by the National Science Foundation's Plant Genome Research Program (Award #0606461).

More information about the array content, design strategy, and experimental data can be found at www.ricediversity.org or www.gramene.org.

For information about genotyping service for the array, contact Charles Pick of DNA Landmarks at [e-mail], Carolyn Wait of Expression Analysis at [e-mail], or call Affymetrix customer service at 1-888-362-2447.

http://investor.affymetrix.com/phoenix.zhtml?c=116408&p=irol…

[kmastra]

Antwort auf Beitrag Nr.: 40.866.838 von Tommi33 am 14.01.11 22:54:18

Moin Tommi33,
du postest hier ständig Affmetrix News im Affymax Forum. Ein x für ein Y. Aber eine ganz andere Firma:

http://www.wallstreet-online.de/diskussion/1162617-1-10/affy…

Nichts für ungut
Sg kmastra

[Tommi33]

Antwort auf Beitrag Nr.: 40.866.993 von kmastra am 14.01.11 23:41:34

Huch, ein dickes Sorry, das kommt davon wenn man nicht richtig liest.

LG Tommi

[Tommi33]

Antwort auf Beitrag Nr.: 40.867.080 von Tommi33 am 15.01.11 00:30:18

Aber im Depot hab ich die richtigen hab ich grad nochmal geschaut. Werd gleich mal gucken ob ich zu Affy was neues finde.

Tommi

[Tommi33]

Affymax Announces Appointment of John Orwin as CEO and a Member of the Board of Directors

Orwin to lead company into commercialization; Morris to consult through September 2011

PALO ALTO, Calif.--(BUSINESS WIRE)-- Affymax, Inc. (Nasdaq:AFFY) today announced that the company's board of directors has appointed John Orwin, the company's president, to succeed Arlene Morris as chief executive officer and member of the board of directors effective February 1, 2011. Ms. Morris will remain a consultant until September 2011.

"Arlene led Affymax during a period of great progress, from identification of its lead compound, peginesatide (Hematide™) through late stage development," said Hollings Renton, Affymax's chairman of the board. "It is with deep gratitude that we recognize her contributions to the organization."

Arlene Morris commented, "I am extremely proud of our many accomplishments at Affymax. I believe the organization is well positioned for the future and it is with great confidence that I turn the helm over to John Orwin, a proven leader in the industry. We recruited John to Affymax with recognition of his strengths in leading commercial organizations which position him ideally to lead the company going forward."

John Orwin added, "I would like to thank Arlene for her leadership of Affymax thus far and for bringing the organization through a critical period of development. We are now in final preparations of our NDA and are on track to submit this application to the Food and Drug Administration in the second quarter of 2011. We believe we are well positioned to commercialize peginesatide upon potential approval for the treatment of anemia in dialysis patients, and look forward to our transition to a commercial organization."

http://www.investors.affymax.com/releasedetail.cfm?ReleaseID…

[Tommi33]

Affymax Announces Appointment of Herb Cross as Chief Financial Officer


PALO ALTO, Calif.--(BUSINESS WIRE)-- Affymax, Inc. (NASDAQ:AFFY) today announced that Herb Cross, the company's vice president of finance and chief accounting officer, will become Affymax's chief financial officer effective March 4, 2011. Mr. Cross' succession to the position is timed with the departure of Paul Cleveland, executive vice president and chief financial officer, who will resign from his post to assume a new role in a private equity firm.

John Orwin, Affymax's chief executive officer, stated, "It is with great regret that I accept Paul's resignation. He has been a tremendous asset and instrumental in the growth and success of the organization during his tenure. In particular, I would like to recognize and thank him for building a strong financial organization, including the appointment of Herb, to succeed him."

Prior to joining Affymax, Mr. Cross was vice president, Finance for Facet Biotech Corporation, a public clinical-stage biotech company. Prior to Facet Biotech, he was corporate controller at PDL BioPharma, a public bio-pharmaceutical company with more than $400 million in annual revenues. Before that, he held positions of increasing responsibility, including vice president, Finance, at Neoforma, Inc., a public e-commerce software company, as well as the position of manager, Assurance and Business Advisory Services at Arthur Andersen, LLP. Mr. Cross earned a B.S. from the Haas School of Business at the University of California, Berkeley.

http://www.investors.affymax.com/releasedetail.cfm?ReleaseID…

[Tommi33]

Affymax to Present at BIO CEO & Investor Conference


PALO ALTO, Calif.--(BUSINESS WIRE)-- Affymax, Inc. (Nasdaq:AFFY) today announced that John Orwin, the company's chief executive officer, will present at the 13th Annual BIO CEO & Investor Conference on Tuesday, January 15, 2011, at 1:30 p.m. Eastern time (10:30 a.m. Pacific time) at the Waldorf-Astoria in New York City.

A live webcast of the presentation will be available on the investors section of the Company's website at www.affymax.com. A replay will also be available for 30 days following the presentation.

http://www.investors.affymax.com/releasedetail.cfm?ReleaseID…

[Tommi33]

Affymax to Present at RBC Capital Markets' Healthcare Conference


PALO ALTO, Calif.--(BUSINESS WIRE)-- Affymax, Inc. (NASDAQ:AFFY) today announced that Jeffrey Knapp, the company's chief commercial officer, will participate in a panel discussion at the 2011 RBC Capital Markets' Healthcare Conference on Thursday, March 3, 2011 at 9:00 a.m. Eastern Time in New York.

A live webcast of the panel discussion will be available on the investors section of the Company's website at www.affymax.com . A replay will also be available for 30 days following the presentation.

About Affymax, Inc.

Affymax, Inc. is a biopharmaceutical company committed to developing novel drugs to improve the treatment of serious and often life-threatening conditions. For additional information, please visit www.affymax.com.

Affymax, Inc.
Sylvia Wheeler, 650-812-8861
Vice President, Corporate Communications

Source: Affymax, Inc.

[Tommi33]

Affymax to Present at Cowen and Company's 31st Annual Health Care Conference

PALO ALTO, Calif.--(BUSINESS WIRE)-- Affymax, Inc. (Nasdaq:AFFY) today announced that John Orwin, the company's chief executive officer, will present at Cowen and Company's 31st Annual Health Care Conference on Tuesday, March 8, 2011 at 8:00 a.m. Eastern Time in Boston.

A live webcast of the presentation will be available on the investors section of the Company's website at www.affymax.com. A replay will also be available for 30 days following the presentation.

http://www.investors.affymax.com/releasedetail.cfm?ReleaseID…

[lunatics]

Affymax enormer Schub durch upgrade

[Tommi33]

Affymax and Takeda Report Additional Phase 3 Clinical Trial Data for Peginesatide in Dialysis Patients at the National Kidney Foundation Spring Clinical Meetings


LAS VEGAS & OSAKA, Japan--(BUSINESS WIRE)-- Affymax, Inc. (Nasdaq: AFFY) and Takeda Pharmaceutical Company Limited (TSE:4502, "Takeda"), today announced results of additional analyses from two Phase 3 studies (EMERALD 1 and 2) of the investigational agent, peginesatide (formerly known as Hematide™) in chronic renal failure (CRF) patients on dialysis with anemia. Building on the primary analysis of the EMERALD studies, which showed that once-monthly peginesatide was comparable to epoetin given up to 13 times a month in maintaining hemoglobin (Hb) levels with a generally similar adverse event rate, these data provide additional information on the maintenance of Hb within treatment targets over time (up to 100 weeks), as well as cardiovascular safety results of this once-monthly agent in the dialysis patients studied.1,2 These data, along with a demographic analysis from the dialysis studies, were part of three poster presentations at the National Kidney Foundation's (NKF) Spring Clinical Meetings in Las Vegas, Nevada.

Peginesatide is in development for the treatment of anemia in CRF patients on dialysis. The EMERALD studies were part of the largest Phase 3 clinical program to support initial registration of an erythropoiesis stimulating agent (ESA) in the treatment of anemia in CRF. The trials evaluated the efficacy and safety of peginesatide administered once-monthly, compared to epoetin alfa or epoetin beta dosed up to 13 times a month, in maintaining Hb levels within the current recommended target range (between 10-12 g/dL), a goal of anemia management. Epoetin alfa or beta were dosed according to their product labels. Dialysis patients randomized to the peginesatide arm were switched from epoetin alfa or epoetin beta to peginesatide.

"The Phase 3 EMERALD program was particularly interesting because the studies evaluated the efficacy and safety of peginesatide in patients who were stable on an epoetin dose and then switched to peginesatide," said Anne-Marie Duliege, M.D., chief medical officer, Affymax. "We look forward to submitting our New Drug Application and reviewing our findings with the FDA."

"Evaluating cardiovascular safety is important in patients receiving dialysis because they typically have several co-existing conditions, such as diabetes and heart disease," said Darryl Sleep, M.D., vice president, Clinical Science, Takeda Global Research & Development Center Inc., a wholly-owned subsidiary of Takeda. "The EMERALD trials were the first Phase 3 registration studies to prospectively evaluate the cardiovascular safety of an erythropoiesis stimulating agent through an adjudicated composite safety analysis. We believe our results provide important information on anemia treatment in this population."

Safety and Efficacy of Peginesatide for Treatment of Anemia in Hemodialysis Patients Previously on Epoetin Alfa or Epoetin Beta (Poster #s 217 and 63), April 27, 2011

The peginesatide data presented at NKF were from two Phase 3 clinical trials known as EMERALD 1 and EMERALD 2. The primary efficacy endpoint for both studies was the comparison of the mean change in Hb levels from baseline to the evaluation period across both treatment groups.1,2 In both Phase 3 trials, peginesatide had similar results to epoetin in maintaining Hb levels within target range.1,2 Specific study results presented at the meeting based on key secondary analyses are as follows:

* EMERALD 1: The percentage of patients whose Hb levels remained within the target range during four-week periods in the initial titration period (weeks 1-28) was 60 to 69 percent in patients who were switched to peginesatide and 65 to 74 percent in those who were maintained on epoetin. Hb levels during four-week periods in the evaluation and long-term follow up periods (weeks 29-52) were maintained in 67 to 75 percent of peginesatide patients and 68 to 75 percent of epoetin patients. In this study, Hb levels were maintained without increasing the need for red blood cell transfusions (10 percent in the peginesatide group versus 9 percent in the epoetin group).1
* The overall adverse event profile of peginesatide was consistent with that of epoetin and the most commonly reported adverse events in the peginesatide and epoetin arms were diarrhea (20 percent versus 14 percent), cough (19 percent versus 20 percent), dyspnea (19 percent versus 20 percent) and nausea (17 percent versus 19 percent).1
* A similar frequency of serious adverse events was observed across groups. Further, a similar frequency of the following cardiovascular events was reported in both treatment groups: death (11.1 percent versus 11.2 percent), stroke (2.3 percent versus 4.5 percent), myocardial infarction (4.8 percent versus 5.9 percent), unstable angina (2.7 percent versus 2.6 percent), congestive heart failure (11.3 percent versus 9.7 percent) and arrhythmia (6.9 percent versus 6.7 percent).
* EMERALD 2: In this trial, 58 to 68 percent of patients switched to peginesatide were within Hb target range during four-week periods in weeks 1-28, compared to 67 to 78 percent who were maintained on epoetin. The number of patients within target range during four-week periods in the evaluation and long-term follow up periods (weeks 29-52) was comparable between treatment groups, with 64 to 70 percent of peginesatide patients within range, versus 65 to 74 percent of those in the epoetin arm. The proportion of patients who received a red blood cell transfusion was similar between peginesatide and the epoetin control (8 percent versus 10 percent).2
* The overall adverse event profile of peginesatide was consistent with that of epoetin and the most commonly reported adverse events in the peginesatide and epoetin arms were muscle spasm (20 percent versus 19 percent), dyspnea (18 percent versus 18 percent), nausea (18 percent versus 20 percent) and diarrhea (17 percent versus 18 percent).2
* A similar frequency of serious adverse events was observed across groups. Also, a similar frequency of the following cardiovascular events was reported in both treatment groups: death (10.5 percent versus 12.5 percent), stroke (2.6 percent versus 2.9 percent), myocardial infarction (4.4 percent versus 4.8 percent), unstable angina (1.8 percent versus 1.8 percent), congestive heart failure (8.1 percent versus 8.4 percent) and arrhythmia (5.0 percent versus 6.2 percent).

Peginesatide Phase 3 Trial Subjects vs. a Random Sample of U.S. Hemodialysis Patients (Poster #163) — April 27, 2011

In addition to the safety and efficacy data, a demographic comparison presented at NKF showed that U.S. patients included in the EMERALD trials had baseline characteristics that are consistent with patients from a random sample of the U.S. adult hemodialysis population (n=8,731).3 Age, severity of chronic kidney disease and medical history of patients in the trials were generally reflective of the real-world population, as captured through Medicare claims data.3

About the EMERALD Studies and the Peginesatide Phase 3 Program

The EMERALD trials were open-label, randomized active-controlled Phase 3 clinical studies that involved over 1,600 dialysis patients. EMERALD 1 included 803 U.S. dialysis patients who were receiving hemodialysis (≥3 months) and were being treated with intravenous (IV) epoetin alfa (≥8 weeks).1 In this trial, patients were randomized to receive once-monthly peginesatide or epoetin alfa one-to-three times a week.1 EMERALD 2 enrolled 823 U.S. and European dialysis patients who were receiving hemodialysis (≥3 months) and were being treated with IV or subcutaneous (SC) injection of epoetin alfa or beta (≥8 weeks). EMERALD 2 patients were randomized to receive once-monthly peginesatide (by IV or SC administration) or epoetin one-to-three times a week.2 These studies were part of the peginesatide Phase 3 program that also included two studies in non-dialysis patients (PEARL 1 and 2). Based on the results of the peginesatide Phase 3 program, the companies are not pursuing an indication in non-dialysis in the U.S. However, while not in our immediate plans, we will continue to evaluate our strategy in the non-dialysis indication. A New Drug Application submission in the U.S. for peginesatide for the treatment of anemia in CRF patients on dialysis is anticipated in the second quarter of 2011.

About Peginesatide

Peginesatide is a novel synthetic, PEGylated peptidic compound that binds to and activates the erythropoietin receptor and thus acts as an ESA. Affymax and Takeda are collaborating on the development of peginesatide and plan to co-commercialize the product if approved in the U.S. The Phase 3 clinical trials were designed to investigate the potential for peginesatide to treat anemia associated with CRF. The product, upon approval, would be commercialized outside the U.S. (in the European Union and Japan) by Takeda.

About Anemia in Chronic Renal Failure

Anemia is a common complication in chronic kidney disease (also referred to as CKD or chronic renal failure).4 Research has shown that anemia impacts the overall health and well being of CKD and dialysis patients and is associated with increased rates of hospitalization and mortality.5 In severe or prolonged cases of anemia, the lack of oxygen in the blood can cause serious and sometimes fatal damage to the heart and other organs.6,7 ESAs are medications commonly prescribed to treat anemia and stimulate red blood cell production.6,7 According to the Center for Medicaid Services (CMS), nearly 95 percent of patients on dialysis in the U.S. are currently receiving ESA treatment for anemia in CRF.8

About Affymax, Inc.

Affymax, Inc. is a biopharmaceutical company committed to developing novel drugs to improve the treatment of serious and often life-threatening conditions. For additional information, please visit www.affymax.com.

This release contains forward-looking statements, including statements regarding the continuation and success of Affymax's collaboration with Takeda, milestones expected to be accomplished, timing, design and progress of the peginesatide development program and the timing and potential regulatory approval and commercialization of peginesatide. Affymax's actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties, including risks relating to our ability to submit a New Drug Application (NDA) in the second quarter, the completeness of the NDA filing, risks relating to data quality and integrity particularly in non-inferiority designed trials, the continued safety and efficacy of peginesatide in clinical development, the timing of patient accrual in ongoing and planned clinical studies, regulatory requirements and approvals, research and development efforts, industry and competitive environment, intellectual property rights and disputes and potential for costs, disruptions and consequences of litigation, financing requirements and ability to access capital and other matters that are described in Affymax's Annual Report on Form 10-K filed with the Securities and Exchange Commission. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Affymax undertakes no obligation to update any forward-looking statement in this press release.

About Takeda Pharmaceutical Company Limited

Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for patients worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.

About Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc.

Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc. are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The respective companies currently market oral diabetes, insomnia, rheumatology, gastroenterology and cardiovascular disease treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for diabetes, gastroenterology, neurology and other conditions. To learn more about these Takeda companies, visit www.tpna.com.

This press release contains forward-looking statements. Forward-looking statements include statements regarding Takeda's plans, outlook, strategies, results for the future, and other statements that are not descriptions of historical facts. Forward-looking statements may be identified by the use of forward-looking words such as "may," "believe," "will," "expect," "project," "estimate," "should," "anticipate," "plan," "assume," "continue," "seek," "pro forma," "potential," "target," "forecast," "guidance," "outlook" or "intend" or other similar words or expressions of the negative thereof. Forward-looking statements are based on estimates and assumptions made by management that are believed to be reasonable, though they are inherently uncertain and difficult to predict. Investors are cautioned not to unduly rely on such forward-looking statements.

Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Some of these risks and uncertainties include, but are not limited to, (1) the economic circumstances surrounding Takeda's business, including general economic conditions in Japan, the United States and worldwide; (2) competitive pressures and developments; (3) applicable laws and regulations; (4) the success or failure of product development programs; (5) actions of regulatory authorities and the timing thereof; (6) changes in exchange rates; (7) claims or concerns regarding the safety or efficacy of marketed products or product candidates in development; and (8) integration activities with acquired companies.

The forward-looking statements contained in this press release speak only as of the date of this press release, and Takeda undertakes no obligation to revise or update any forward-looking statements to reflect new information, future events or circumstances after the date of the forward-looking statement. If Takeda does update or correct one or more of these statements, investors and others should not conclude that Takeda will make additional updates or corrections.


References
1. Schiller, et al. "Safety and Efficacy of Peginesatide for Treatment of Anemia in Hemodialysis Patients Previously on Epoetin Alfa." NKF 2011 Abstract.
2. Besarab, et al. "Safety and Efficacy of Peginesatide for Treatment of Anemia in Hemodialysis Patients Previously on Epoetin Alfa or Beta." NKF 2011 Abstract.
3. Yang, et al. "Peginesatide Phase 3 Trial Subjects vs. a Random Sample of United States Hemodialysis Patients." NKF 2011 Abstract.
4.

National Kidney and Urologic Diseases Information Clearinghouse. "Anemia in Kidney Disease and Dialysis." http://kidney.niddk.nih.gov/kudiseases/pubs/anemia. Accessed March 3, 2011
5.

Astor et al "Association of Kidney Function with Anemia: The Third National Health and Nutrition Examination Survey (1988-1992). Archives of Internal Medicine 2002; 162: 1401-1408
6.

National Kidney Foundation. "Anemia and Chronic Kidney Disease." http://www.kidney.org/Atoz/pdf/anemia.pdf. Accessed March 2, 2011.
7.

National Heart Lung Blood Institute "What is Anemia." http://www.nhlbi.nih.gov/health/dci/Diseases/anemia/anemia_w… is.html. Accessed March 2, 2011.
8.

Centers for Medicare and Medicaid Services. "MEDCAC Meeting 3/24/2010 - Erythopoiesis Stimulating Agents (ESA) in Anemia Related to Kidney Disease." http://www.cms.gov/medicare-coverage-database/details/medcac… Accessed March 4, 2011.




Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=6700852〈=en

Corporate Contacts:
Affymax, Inc.
Sylvia Wheeler, 650-812-8861
Vice President, Corporate Communications
or
Takeda Global Research & Development Center, Inc.
Josephine Zammuto, 224-554-2795
Corporate Communications
or
Takeda Pharmaceutical Company Limited
Mihoko Shinomiya, [phone]
Corporate Communications Dept.

Source: Affymax, Inc. & Takeda Pharmaceutical Company Limited

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Ich lasse laufen bis 10 USD.

[lunatics]

Affymax gibt Vollgas

[Tommi33]

Affymax and Takeda Announce the Submission of a New Drug Application for Peginesatide for the Treatment of Anemia Associated with Chronic Renal Failure in Patients on Dialysis


PALO ALTO, Calif. & OSAKA, Japan--(BUSINESS WIRE)-- Affymax, Inc. (NASDAQ:AFFY) and Takeda Pharmaceutical Company Limited (TSE: 4502, "Takeda") today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the investigational agent peginesatide (formerly known as Hematide™) for the treatment of anemia associated with chronic renal failure (CRF) in adult patients on dialysis.

Peginesatide is a synthetic, PEGylated peptidic compound that binds to and activates the erythropoietin receptor and thus acts as an erythropoiesis stimulating agent (ESA). The agent is being co-developed by Affymax and Takeda. The NDA includes data from two Phase 3 studies (EMERALD 1 and 2) that evaluated the efficacy and safety of peginesatide, dosed once every four weeks, compared to epoetin alfa or epoetin beta, dosed more frequently (according to the product labels), in maintaining hemoglobin (Hb) levels. In the studies, CRF patients on dialysis who were receiving stable doses of epoetin, were randomized to receive once-monthly peginesatide or continue treatment with epoetin. The EMERALD findings suggested that once-monthly peginesatide was similar to epoetin in maintaining Hb levels in CRF patients on dialysis with anemia with a similar adverse event rate.

"The submission of the peginesatide NDA is an important milestone for Affymax and the result of dedication and diligence by both the Affymax and Takeda teams," said John Orwin, chief executive officer, Affymax. "Anemia is a debilitating condition for chronic renal failure patients on dialysis, and our program illustrates the potential of peginesatide as an important once-monthly therapeutic option for patients and providers, if approved. We look forward to working with the FDA as they review the data package for the peginesatide New Drug Application."

"We're pleased to have partnered with Affymax on a submission that includes data from the largest Phase 3 program to support the initial registration of an ESA for the treatment of anemia of chronic renal failure and the first to prospectively evaluate the cardiovascular safety of an ESA via an analysis of independently adjudicated cardiovascular events," said Azmi Nabulsi, M.D., M.P.H, president of Takeda Global Research & Development Center, Inc. U.S. "To date, limited options for treating anemia in chronic renal failure patients on dialysis exist. The peginesatide New Drug Application represents an important step in the evaluation of a potentially new treatment for this common condition in chronic renal failure."

About Anemia in Chronic Renal Failure (CRF)

Anemia is a common complication in chronic kidney disease (also referred to as CKD or chronic renal failure), because the impaired kidneys are not able to produce enough erythropoietin, the hormone that promotes the production of oxygen-carrying red blood cells.1 Research has shown that anemia impacts the overall health and well being of CKD patients and is associated with increased rates of hospitalization and mortality.2 In severe or prolonged cases of anemia, the lack of oxygen in the blood can cause serious and sometimes fatal damage to the heart and other organs.3,4

ESAs, which stimulate red blood cell production, are commonly prescribed to treat anemia in CRF.3,4 According to the Centers for Medicare and Medicaid Services, more than 95 percent of patients on dialysis in the U.S. are currently receiving ESA treatment for anemia in CRF.5

About Peginesatide

Affymax and Takeda are collaborating on the development of peginesatide and plan to co-commercialize the product if approved in the United States. The product, upon approval, will be commercialized outside the United States by Takeda. The most common adverse events reported in the clinical studies were diarrhea, cough, dyspnea, nausea, and muscle spasm.

About Affymax, Inc.

Affymax, Inc. is a biopharmaceutical company committed to developing novel drugs to improve the treatment of serious and often life-threatening conditions. For additional information, please visit www.affymax.com.

[Tommi33]

Affymax(R) Reports Second Quarter 2011 Financial Results


Reaffirms Guidance for 2011

PALO ALTO, Calif.--(BUSINESS WIRE)-- Affymax, Inc. (Nasdaq:AFFY) today reported financial results for the second quarter ended June 30, 2011. The net loss for the second quarter of 2011 was $12.5 million compared to net income of $17.3 million for the second quarter of 2010. The net income in second quarter 2010 was due to $30 million in milestone payments paid to Affymax by Takeda in connection with database lock for the Phase 3 trials under their 2006 collaboration for development of peginesatide (formerly known as Hematide™).

Affymax recognized revenue for the quarter ended June 30, 2011 of $14.2 million compared to $54.3 million for the quarter ended June 30, 2010. In addition to the unusually high revenue in 2010 due to the milestone payment mentioned above, the decrease in revenue in 2011 was due to decreased reimbursement from Takeda resulting from reduced development expenses.

Research and development expenses for the quarter ended June 30, 2011, were $18.6 million compared to $28.9 million for the quarter ended June 30, 2010. The decrease was primarily due to the completion of the treatment and follow up of Phase 3 clinical trials for peginesatide in 2010.

General and administrative expenses for the quarter ended June 30, 2011 were $8.1 million compared to $8.2 million for the quarter ended June 30, 2010. The decrease was primarily due to reductions in consulting services.

The company had cash and investments of $124.4 million as of June 30, 2011, a decrease of $28.7 million from March 31, 2011. In addition to supporting normal course operations, the cash utilization in the second quarter 2011 included payment of $5.3 million to Takeda relating to clinical trial accrual adjustments recorded in the fourth quarter of 2010. The $10 million milestone payment due from Takeda as a result of the FDA acceptance of the NDA submission in July is expected to be received in the third quarter.

Financial Guidance

Affymax reaffirms its previously issued financial guidance of total expected 2011 payments from Takeda of $20 million to $25 million and total 2011 operating expenses of $105 million to $110 million, excluding stock-based compensation.

About Affymax, Inc.

Affymax, Inc. is a biopharmaceutical company committed to developing novel drugs to improve the treatment of serious and often life-threatening conditions. Affymax's product candidate, peginesatide, is currently under FDA review for the treatment of anemia in dialysis patients with chronic kidney disease. For additional information, please visit www.affymax.com.

[Tommi33]

Affymax Announces Assignment of March 27, 2012 PDUFA Date for Peginesatide New Drug Application


PALO ALTO, Calif.--(BUSINESS WIRE)-- Affymax, Inc. (Nasdaq: AFFY) today announced that the U.S. Food and Drug Administration has assigned a Prescription Drug User Fee Act (PDUFA) action date of March 27, 2012 for the review of the investigational agent peginesatide (formerly known as Hematide™) New Drug Application (NDA). The company had announced on July 27, 2011 that the FDA accepted the peginesatide NDA submission for review.

If approved, peginesatide will be the first once-monthly erythropoiesis stimulating agent (ESA) available for the treatment of anemia associated with CKD patients on dialysis in the United States.

Peginesatide is a synthetic, PEGylated peptidic compound that binds to and activates the erythropoietin receptor and thus acts as an ESA. The NDA included data from two Phase 3 studies (EMERALD 1 and 2) that evaluated the efficacy and safety of peginesatide, dosed once every four weeks, compared to epoetin alfa or epoetin beta, dosed more frequently (according to the product labels) in maintaining hemoglobin (Hb) levels. In the studies, over 1,600 CKD patients on dialysis who were receiving stable doses of epoetin were randomized to receive once-monthly peginesatide or continue treatment with epoetin. The EMERALD findings suggested that once-monthly peginesatide was comparable to epoetin in maintaining Hb levels in CKD patients on dialysis with anemia with a similar adverse event rate. The most common adverse events reported in the clinical studies were diarrhea, cough, dyspnea, nausea, and muscle spasm. A similar frequency of serious adverse events was reported between the EMERALD treatment groups.

"To date, limited options exist for treating anemia in chronic kidney disease patients on dialysis," said John Orwin, chief executive officer of Affymax. "The peginesatide New Drug Application represents an important step in the evaluation of this potential new treatment for the many dialysis patients impacted by this common condition."

www.affymax.com

[Tommi33]

Affymax Announces FDA Advisory Committee to Review Peginesatide


Oncologic Drugs Advisory Committee Meeting Scheduled for December 7, 2011

PALO ALTO, Calif.--(BUSINESS WIRE)-- Affymax, Inc. (Nasdaq:AFFY) today announced that the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) will review the New Drug Application (NDA) for peginesatide proposed for the treatment of anemia associated with chronic kidney disease (CKD) in adult patients on dialysis on December 7, 2011 during the afternoon session. The FDA has established an action date of March 27, 2012 under the Prescription Drug User Fee Act (PDUFA).

Erythropoiesis stimulating agents (ESAs) are reviewed by the Office of Hematology and Oncology Products (OHOP). As such, FDA has designated ODAC for the review of peginesatide. Information related to the meeting can be found on the U.S. Office of the Federal Register Website at: http://www.fda.gov/RegulatoryInformation/Dockets/FR/default.…

The company intends to begin a self-imposed quiet period on November 16, 2011 in anticipation of receipt of FDA briefing documents, and this quiet period will continue until after the Advisory Committee meeting is completed.

If approved, peginesatide will be the first once-monthly ESA available for the treatment of anemia associated with CKD patients on dialysis in the United States.

Peginesatide is a synthetic, PEGylated peptidic compound that binds to and stimulates the erythropoietin receptor and thus acts as an ESA. The NDA included data from two Phase 3 studies (EMERALD 1 and 2) that evaluated the efficacy and safety of peginesatide, dosed once every four weeks, compared to epoetin alfa or epoetin beta, dosed more frequently (according to the product labels) in maintaining hemoglobin (Hb) levels in CKD patients on dialysis with anemia. In the studies, over 1,600 CKD patients on dialysis who were receiving stable doses of epoetin were randomized to receive once-monthly peginesatide or continue treatment with epoetin. The EMERALD findings suggested that once-monthly peginesatide was comparable to epoetin in maintaining Hb levels in CKD patients on dialysis with anemia with a similar adverse event rate. The most common adverse events reported in the clinical studies were diarrhea, cough, dyspnea, nausea, and muscle spasm. A similar frequency of serious adverse events was reported between the EMERALD treatment groups.

[Tommi33]

Affymax(R) Reports Third Quarter 2011 Financial Results


PALO ALTO, Calif.--(BUSINESS WIRE)-- Affymax, Inc. (Nasdaq:AFFY) today reported financial results for the third quarter ended September 30, 2011. The net loss for the third quarter of 2011 was $9.8 million compared to a net loss of $12.0 million for the third quarter of 2010.

Affymax recognized revenue for the quarter ended September 30, 2011 of $13.2 million compared to $16.8 million for the quarter ended September 30, 2010. During the quarter ended September 30, 2011, we received a $10 million milestone payment from Takeda upon FDA acceptance of our new drug application for review. The decrease in revenue in 2011 was due to decreased reimbursement from Takeda resulting from reduced development expenses.

Research and development expenses for the quarter ended September 30, 2011, were $14.9 million compared to $21.1 million for the quarter ended September 30, 2010. The decrease was due to lower costs for API manufacturing, contractors and consultants in the third quarter of 2011, largely as a result of the submission of our NDA to the FDA for review in the second quarter of 2011.

General and administrative expenses for the quarter ended September 30, 2011 were $8.2 million compared to $7.8 million for the quarter ended September 30, 2010. The increase was primarily due to higher commercial expenses related to expansion of our commercial capabilities.

The company had cash and investments of $116.4 million as of September 30, 2011, which includes the $10 million milestone payment from Takeda upon FDA acceptance of the NDA for peginesatide.

Updated Financial Guidance

Affymax is updating its financial guidance for 2011. With respect to income, Affymax expects total 2011 payments from Takeda to be in the range of $25 million to $30 million, which is at or above the high end of the previously issued range of $20 million to $25 million.

With respect to total operating expenses Affymax expects to incur $95 million to $100 million in operating expenses during 2011, excluding stock-based compensation. This is lower than the previously issued guidance of $105 million to $110 million in operating expenses during 2011, excluding stock-based compensation. This reduction is due largely to the impact of expense reduction efforts as well due to delay in the commencement of Phase 3b studies to evaluate the process and outcomes of converting dialysis centers from a three times per week ESA to once-monthly peginesatide.

As a result, the company expects to end 2011 with approximately $95 million to $100 million in cash, cash equivalents and investments. Affymax continues to expect cash resources, ongoing Takeda reimbursement and milestone payments from Takeda to fund operations through 2012. Under the terms of its 2006 collaboration with Takeda, Affymax is due a $50 million milestone upon approval of the NDA by the FDA.

www.affymax.com

[Tommi33]

FDA Advisory Committee Voted in Favor of Benefit/Risk Profile for Peginesatide for Treatment of Anemia in Chronic Kidney Disease Patients on Dialysis


SILVER SPRING, Md. & OSAKA, Japan--(BUSINESS WIRE)-- Affymax, Inc. (Nasdaq:AFFY) and Takeda Pharmaceutical Company Limited (TSE:4502), today announced that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 15 to 1, with 1 abstention, that peginesatide demonstrated a favorable benefit/risk profile for use in the treatment of dialysis patients with anemia due to chronic kidney disease (CKD).

"We're encouraged by the panel's positive view of the benefit/risk profile of peginesatide in the dialysis setting," said John Orwin, president and CEO of Affymax. "Anemia affects many patients in the dialysis setting, and we look forward to working with the FDA as they complete their evaluation of peginesatide. As a once-monthly treatment, peginesatide, if approved, has the potential to be an important option in the management of anemia in patients living with this condition."

While the FDA is not bound by the recommendations of its advisory committees, their guidance will be considered by the FDA in its review of the New Drug Application (NDA) that was submitted for peginesatide in May 2011. The scheduled Prescription Drug User Fee Act (PDUFA) date for peginesatide is March 27, 2012.

"Today's ODAC vote represents an important step in the peginesatide New Drug Application review process," said Azmi Nabulsi, MD, president, Takeda Global Research & Development Center, Inc. "As we heard from the discussion today, limited therapeutic options are available for the treatment of anemia in dialysis patients with chronic kidney disease. Affymax and Takeda will continue efforts to make this alternative available to dialysis patients and the providers who treat them."

http://www.affymax.com

LG Tommi

[Tommi33]

Affymax to Receive $5 Million Milestone Payment for Acceptance of European Marketing Authorization Application for Peginesatide


PALO ALTO, Calif.--(BUSINESS WIRE)-- Affymax, Inc. (Nasdaq: AFFY) today announced that it will receive a $5 million development milestone payment from Takeda Pharmaceutical Company as part of the companies' exclusive global agreement to develop and commercialize peginesatide. The milestone is triggered by the European Medicines Agency (EMA) acceptance of the Marketing Authorization Application (MAA) for the investigational compound peginesatide for the treatment of anemia associated with chronic kidney disease (CKD) in adult patients on dialysis.

"We are delighted with Takeda's execution on the European front and are encouraged by the EMA acceptance of the MAA," said John Orwin, president and CEO of Affymax. "While we are concurrently preparing for potential commercialization of peginesatide in the United States, we are pleased that progress is being made to potentially make the product available outside the U.S."

Peginesatide was discovered by Affymax, and if approved, will be co-marketed by Affymax and Takeda in the United States. Takeda has commercialization rights in the European Union. In the United States, the scheduled Prescription Drug User Fee Act (PDUFA) date for peginesatide is March 27, 2012.

http://www.investors.affymax.com/releasedetail.cfm?ReleaseID…

[Tommi33]

Affymax Announces Yearend 2011 Financial Results Teleconference and Webcast


PALO ALTO, Calif.--(BUSINESS WIRE)-- Affymax, Inc. (Nasdaq: AFFY) today announced that it will host its first financial results teleconference and webcast with management to provide a general business overview, as well as to discuss full year 2011 financial results, on Wednesday, March 14, 2012, at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time). Financial results for the year ended December 31, 2011 will be released after market close on March 14, 2012.

Interested parties can listen to the live teleconference by dialing [phone] from the U.S. or [phone] for international callers. Individuals may access the live audio webcast by visiting: http://www.investors.affymax.com/events.cfm. A replay of the webcast will be available on the Company's website for 30 days following the live event.

About Affymax, Inc.

Affymax, Inc. is a biopharmaceutical company committed to developing novel drugs to improve the treatment of serious and often life-threatening conditions. For additional information, please visit www.affymax.com.

[Tommi33]

Affymax(R) Reports Year End 2011 Financial Results


- Provides Financial Guidance for 2012 -

PALO ALTO, Calif.--(BUSINESS WIRE)-- Affymax, Inc. (Nasdaq:AFFY) today reported financial results for the year ended December 31, 2011. The net loss for the year ended December 31, 2011 was $61.4 million compared to a net loss of $14.1 million for the year ended December 31, 2010.

Affymax reported revenue for the year ended December 31, 2011 of $47.7 million compared to $112.5 million for the year ended December 31, 2010. The decrease in revenue was the result of lower collaboration revenue from its partnership with Takeda Pharmaceutical Company Limited (Takeda), under their 2006 collaboration for development of peginesatide, due largely to a reduction in development milestones. Specifically, Affymax received $10.0 million in milestones during the year ended December 31, 2011 as compared to $35.0 million in the year ended December 31, 2010. In addition, reimbursement for development expenses was significantly lower for the year ended December 31, 2011 due largely to the completion of the Phase 3 clinical trials in chronic kidney disease in early 2010.

Research and development expenses for the year ended December 31, 2011 were $76.3 million compared to $93.6 million for the year ended December 31, 2010. The decrease was primarily due to a reduction in expenses associated with Phase 3 clinical development.

Selling, general and administrative expenses for the year ended December 31, 2011 were $32.8 million, a slight decrease as compared to $33.3 million for the year ended December 31, 2010, primarily due to lower legal fees, partially offset by increasing commercial expenses in 2011.

Affymax had cash and investments of $99.6 million at December 31, 2011.

"2011 was a banner year for Affymax demonstrated by our progress and accomplishments which set the stage for potential approval and commercial launch of our first marketed therapeutic product," said John Orwin, chief executive officer at Affymax. "Looking at planned activities in 2012, our highest priority is preparing for, and executing on, the potential launch of peginesatide with our partner Takeda in the dialysis market. We look forward to keeping you apprised of our progress."

2012 Financial Guidance

With respect to revenue in 2012, Affymax expects to earn several milestone payments totaling approximately $60 million from Takeda in 2012. In addition to the $5.0 million milestone payment already received as a result of the acceptance of the Marketing Authorization Application for peginesatide in Europe, Affymax also expects to receive additional milestones of $50 million related to the approval of peginesatide in the U.S. and approximately $5 million from Takeda associated with reimbursements under the Janssen agreement upon the achievement of certain regulatory and commercial events. Affymax also expects to continue to receive reimbursement from Takeda of 70 percent of third party expenses associated with research and development, as well as 50 percent reimbursement of both third-party and FTE related expenses associated with commercial activities as provided under the terms of the collaboration agreement. The agreement provides that upon commercialization of peginesatide, Affymax will receive quarterly profit equalization payments from Takeda to effect a 50/50 profit split on product sales between the parties. Affymax will not be giving peginesatide product sales guidance for 2012.

With respect to operating expenses Affymax expects to incur $45 million to $50 million in research and development expenses and $90 million to $95 million in selling, general and administrative expenses, resulting in total expected operating expenses for 2012 of $135 million to $145 million, excluding stock based compensation. For 2012, we expect to incur total stock-based compensation expense of approximately $10 million dollars.

This increase in operating expenses relative to 2011 is primarily a result of significantly increased investment in the Affymax commercial and medical affairs organizations, partially offset by reductions in our research and development spending as the company directs resources to support the potential commercialization of peginesatide in 2012.

Affymax currently expects existing cash resources, milestone payments from Takeda, ongoing Takeda reimbursement and profit equalization payments from Takeda to fund its operations well into 2013.

Conference Call

Affymax's management will host a teleconference and webcast to discuss the company's financial results and provide a general business update today at 1:30 p.m. PT (4:30 p.m. ET). Interested parties may listen to the live call by dialing [phone] from the U.S. or [phone] for international callers. Individuals may access the live audio webcast by visiting: http://www.investors.affymax.com/events.cfm. A replay of the webcast will be available on the Company's website for 30 days following the live event.

About Affymax, Inc.

Affymax, Inc. is a biopharmaceutical company committed to developing novel drugs to improve the treatment of serious and often life-threatening conditions. A New Drug Application for Affymax's product candidate, peginesatide, for the treatment of anemia in adult chronic kidney disease patients on dialysis is under review by the U.S. Food and Drug Administration. For additional information, please visit www.affymax.com

[Tommi33]

Affymax and Takeda Announce FDA Approval of OMONTYS(R) (Peginesatide) Injection for the Treatment of Anemia Due to Chronic Kidney Disease (CKD) in Adult Patients on Dialysis


Only Once-Monthly ESA Treatment For Dialysis Patients To Be Made Available In The United States

PALO ALTO, Calif. & OSAKA, Japan--(BUSINESS WIRE)-- Affymax, Inc. (Nasdaq:AFFY) and Takeda Pharmaceutical Company Limited (TSE:4502), today announced that the U.S. Food and Drug Administration (FDA) approved OMONTYS® (peginesatide) Injection for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis. OMONTYS is the only once-monthly erythropoiesis-stimulating agent (ESA) for anemia to be made available to the dialysis patient population in the United States.

The FDA's decision was based on a New Drug Application (NDA), which included results from two randomized, controlled, open-label, Phase 3 studies (EMERALD 1 and 2) that demonstrated the safety and efficacy of OMONTYS dosed once monthly, compared to epoetin dosed between one-to-three times per week (according to product labels), in maintaining hemoglobin (Hb) levels in anemic CKD patients on dialysis. In these studies, the most commonly reported adverse reactions were shortness of breath, diarrhea, nausea, cough and arteriovenous fistula site complication. The EMERALD studies were part of the largest clinical program to support the NDA of an ESA in the treatment of anemia in CKD. Enrolling 2,606 patients, including approximately 1,600 dialysis patients, the OMONTYS Phase 3 program was also the first to prospectively compare, in a head-to-head manner, the cardiovascular safety of different ESAs. Cardiovascular safety was evaluated based on a composite cardiovascular safety endpoint adjudicated by a blinded and independent committee. See below for Important Safety Information about OMONTYS, including Boxed Warnings as well as limitations of use.

In the approval action letter, the FDA outlined post-marketing requirements: an observational study and a randomized controlled trial to be completed with final reports submitted in 2018 and 2019, respectively. The objectives of the studies are to evaluate cardiovascular safety and assess safety of long-term use in adult patients on dialysis, in particular in the incident patient population. In addition, the post-marketing commitment includes the initiation of pediatric studies with target dates for completion between 2016 and 2027. Letters will be sent to nephrology healthcare providers as part of a Risk Evaluation and Mitigation Strategy (REMS) to inform them that OMONTYS is not indicated in patients with CKD not on dialysis. In two trials of OMONTYS, patients with CKD not on dialysis experienced increased specific cardiovascular events.

"The approval of OMONTYS now provides a therapeutic alternative to treat anemia of CKD in adult patients on dialysis, one of the most common complications affecting this patient population," said John Orwin, chief executive officer, Affymax. "For over two decades, doctors have relied primarily on one erythropoietin-based treatment in the dialysis setting. With OMONTYS, doctors and patients will have access to a once-monthly alternative for the treatment of anemia in adult CKD patients on dialysis."

"The FDA's approval of OMONTYS signifies an important milestone for the partnership between Takeda and Affymax as we fulfill our goal of providing an important new treatment option for the hundreds of thousands of CKD patients on dialysis who live with anemia," said Azmi Nabulsi, M.D., president, Takeda Global Research & Development Center, Inc. "OMONTYS is an example of our commitment to making treatment options available that accommodate the needs of evolving healthcare markets, such as the renal community."

Anemia (a condition in which blood has a lower than normal number of red blood cells) is a common complication in dialysis patients because their kidneys no longer produce enough erythropoietin, the hormone that stimulates red blood cell production in the body. According to the Centers for Medicaid and Medicare Services (CMS), nearly 95 percent of dialysis patients in the United States are being treated for anemia with ESAs. Until the approval of OMONTYS, ESAs were recombinant (genetically engineered) versions of endogenous erythropoietin (erythropoietin that is made in the patient's body) that are injected up to three times a week. OMONTYS is a synthetic, pegylated, peptide-based ESA that is dosed once monthly.

"For dialysis patients, anemia is another aspect of their challenging condition that must be addressed," said Brigitte Schiller, M.D., chief medical officer, Satellite Healthcare, Inc. "As a nephrologist who oversees the care of adult CKD patients on dialysis, I am glad to now have another option for the treatment of anemia."

Affymax Teleconference and Webcast

Affymax will host a teleconference and webcast at 11:45 a.m. Pacific Time; 2:45 p.m. Eastern Time today, Tuesday, March 27 to further discuss the FDA approval of OMONTYS. Interested parties can listen to the live teleconference by dialing [phone] from the U.S. or [phone] for international callers. Individuals may access the live audio webcast by visiting www.affymax.com and going to the Investors section. A replay of the webcast will be available on the Company's website for 30 days following the live event.

www.affymax.com

[Tommi33]

OMONTYS(R) (Peginesatide) Injection Now Available for Adult Chronic Kidney Disease (CKD) Patients on Dialysis in the United States


-- Only Once-Monthly Erythropoiesis-Stimulating Agent Launched In The United States --

PALO ALTO, Calif. & OSAKA, Japan--(BUSINESS WIRE)-- Affymax, Inc. (NASDAQ:AFFY) and Takeda Pharmaceutical Company Limited (TSE:4502), today announced that OMONTYS® (peginesatide) Injection is now available only for use in treating anemia due to chronic kidney disease (CKD) in adult patients on dialysis. OMONTYS is the only once-monthly erythropoiesis-stimulating agent (ESA) for anemia available to the dialysis patient population in the United States. OMONTYS is co-marketed by Affymax and Takeda Pharmaceuticals U.S.A. (TPUSA) and distributed by TPUSA. See below for Full Indication, Limitations of Use and Important Safety Information including Boxed WARNINGS.

OMONTYS was approved by the U.S. Food and Drug Administration (FDA) on March 27, 2012. It is administered either intravenously (IV) or subcutaneously (SC) as a single monthly injection. Dialysis providers interested in ordering OMONTYS should contact their group purchasing organizations (GPOs), specialty distributors or call 1-855-GOMONTYS (1-855-466-6689).

"Today's announcement represents an important milestone in the field as nephrologists and anemia nurses will now be able to use the first once-monthly treatment for anemia for adult dialysis patients available in the United States," said John Orwin, chief executive officer, Affymax. "We are excited to partner with the dialysis community and support the important work they do for patients."

"We look forward to working with the dialysis community as they implement this once-monthly medicine into their practice," said Douglas Cole, president, Takeda Pharmaceuticals U.S.A. "In partnership with Affymax, we will support the providers and physicians as they convert their adult CKD patients on dialysis to OMONTYS."

Takeda's consolidated financial statements for the 2011 fiscal year will be announced on May 11, 2012. The fiscal 2012 outlook and Mid-Range Plan 2012-14 will also be presented, which will include this product launch.

www.affymax.com

[Tommi33]

Affymax Promotes Michael Holfinger, Ph.D., to Vice President, Manufacturing and CMC Development


PALO ALTO, Calif.--(BUSINESS WIRE)-- Affymax, Inc. (Nasdaq: AFFY) today announced the promotion of Michael Holfinger, Ph.D., to vice president, manufacturing and CMC development. Dr. Holfinger, who has more than two decades of experience in global manufacturing services for pharmaceutical and biotechnology companies, joined Affymax in 2006 as director, process development and manufacturing.

"During his tenure at Affymax, Mike has shown impressive leadership skills and made significant contributions to our process and manufacturing development program for OMONTYS," said John Orwin, chief executive officer of Affymax. "Looking ahead, his proven track record of overseeing complex commercial production at a global level and his intimate familiarity with the manufacturing process we have developed with our partner, Takeda, will be essential as we increase commercial production."

Prior to joining Affymax, Dr. Holfinger held multiple positions at Pfizer, including most recently as senior manager in the API support team where he was responsible for change management, project management and technical support activities necessary to ensure an economical uninterrupted commercial supply of pharmaceutical ingredients for various products. Prior to Pfizer, Dr. Holfinger held multiple positions within the chemical process research and development group at Pharmacia Corporation, where he was responsible for implementation of commercial processes for the manufacturing of chemical intermediates and active pharmaceutical ingredients. From 1997-2004, he was a course instructor at the Pharmaceutical Education & Research Institute. He earned his Ph.D. in chemical engineering from the University of Wisconsin-Madison and received a dual B.S. degree in applied science, paper science, and engineering and chemistry at Miami University.

About Affymax, Inc.

Affymax, Inc. is a biopharmaceutical company based in Palo Alto, California. Affymax's mission is to discover, develop and deliver innovative therapies that improve the lives of patients with kidney disease and other serious and often life-threatening illnesses.

The company's first marketed product, OMONTYS® (peginesatide) Injection, was approved by the U.S. Food and Drug Administration (FDA) in March 2012. For additional information, please visit www.affymax.com.

[Tommi33]

Affymax Reports Third Quarter 2012 Financial Results


PALO ALTO, Calif.--(BUSINESS WIRE)-- Affymax, Inc. (NASDAQ: AFFY) today reported financial results for the third quarter ended September 30, 2012. The net loss for the third quarter of 2012 was $24.6 million (or ($0.68) per share) compared to a net loss of $9.8 million (or ($0.28) per share) for the third quarter of 2011.

Affymax recognized total revenue for the quarter ended September 30, 2012, of $13.6 million compared to $13.2 million for the quarter ended September 30, 2011. Revenue for the quarter ended September 30, 2012 primarily consisted of a $10.4 million profit equalization payment earned from its partner, Takeda Pharmaceutical Company Limited (Takeda) related to OMONTYS® (peginesatide) Injection product sales during the period. OMONTYS net product sales, as provided by Takeda, were $15.0 million for the quarter. In addition, Affymax earned a $2.25 million milestone payment from Takeda during the quarter as a result of the commercial progress achieved with OMONTYS during its product launch. Revenue for the quarter ended September 30, 2011 consisted of a $10 million regulatory milestone payment from Takeda and pre-approval research and development and commercialization expenses reimbursable by Takeda.

Research and development expenses for the quarter ended September 30, 2012, were $11.4 million compared to $14.9 million for the quarter ended September 30, 2011. The decrease was primarily due to reduced consultant and personnel-related costs as a result of the completion of both the filing of the OMONTYS New Drug Application with the U.S. Food and Drug Administration (FDA) in May 2011 and the preparation for an FDA advisory committee meeting which occurred in December 2011. These decreases were partially offset by clinical trial activity for the company's Phase 3b trial during the current quarter.

Selling, general and administrative expenses for the quarter ended September 30, 2012, were $26.2 million compared to $8.2 million for the quarter ended September 30, 2011. The increase was primarily due to increases in commercial and medical affairs costs, including personnel-related costs associated with the establishment of its commercial and medical affairs field organizations, as the company continues to execute on the launch and commercialization of OMONTYS.

The company had cash and investments of $100.0 million as of September 30, 2012.

Updated Financial Guidance

Affymax is updating its financial guidance for 2012. With respect to collaboration revenue, Affymax has earned milestone payments of $60.3 million and is not expecting additional milestone payments in 2012, consistent with its previously issued guidance. Affymax is not providing profit equalization payment or OMONTYS net product sales guidance for 2012.

With respect to operating expenses, Affymax now expects to incur $130 million to $135 million in total operating expenses for 2012, excluding stock based compensation. This reduction from the previously issued operating expense guidance of $135 million to $145 million for 2012 is primarily driven by lower than expected increases in selling, general and administrative expenses as a result of cost savings.

"We continue to be pleased with our commercial progress since the launch of OMONTYS in the second quarter of this year," said John Orwin, chief executive officer of Affymax. "A number of dialysis providers are evaluating the conversion process and experience with OMONTYS, including a key large dialysis organization and four medium dialysis organizations, while some of the smaller dialysis providers have completely converted centers to the once-monthly drug."

Conference Call with Management Today

Management will host a teleconference and webcast to provide a general business overview, as well as to discuss third quarter 2012 financial results today, November 8, 2012, at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time).

Interested parties can listen to the live teleconference by dialing [phone] from the U.S. or [phone] for international callers. Individuals may access the live audio webcast by visiting: http://www.investors.affymax.com/events.cfm. A replay of the webcast will be available on the Company's website for 30 days following the live event.

About Affymax, Inc.

Affymax, Inc. is a biopharmaceutical company based in Palo Alto, California. Affymax's mission is to discover, develop and deliver innovative therapies that improve the lives of patients with kidney disease and other serious and often life-threatening illnesses.

The company's first marketed product, OMONTYS® (peginesatide) Injection, was approved by the U.S. Food and Drug Administration (FDA) in March 2012. For additional information, please visit www.affymax.com.

[Tommi33]

Takeda and Affymax Announce Supply Agreement for OMONTYS(R) (Peginesatide) Injection with DSI Renal


DEERFIELD, Ill. & PALO ALTO, Calif.--(BUSINESS WIRE)-- Takeda Pharmaceuticals U.S.A., Inc. (TPUSA) and Affymax, Inc. (Nasdaq: AFFY) today announced that Takeda Pharmaceuticals America, Inc. (TPA) has entered into a supply agreement for sourcing and supply of OMONTYS® (peginesatide) Injection with DSI Renal, one of the largest dialysis providers in the United States (U.S.). OMONTYS is the only once-monthly erythropoiesis-stimulating agent (ESA) for anemia available to the adult dialysis patient population with chronic kidney disease (CKD) in the U.S.

The agreement allows DSI Renal to purchase OMONTYS for use within its organization and provides for discounts and rebates on the product, subject to certain requirements. DSI Renal has indicated that they plan to initially evaluate OMONTYS in selected centers, and then, based on experience, evaluate the potential to expand to additional centers. Financial terms were not disclosed.

"We look forward to working with DSI Renal as they integrate OMONTYS into their dialysis centers," stated John Orwin, chief executive officer of Affymax. "With this agreement, we now have supply agreements in place with five out of the six medium-sized dialysis organizations in the U.S."

OMONTYS was approved by the U.S. Food and Drug Administration (FDA) on March 27, 2012, for the treatment of anemia due to CKD in adult patients on dialysis. OMONTYS is not indicated, and is not recommended, for use in patients with CKD not on dialysis, in patients receiving treatment for cancer and whose anemia is not due to CKD, or as a substitute for red blood cell (RBC) transfusions in patients who require immediate correction of anemia. OMONTYS has not been shown to improve symptoms, physical functioning, or health-related quality of life.

http://www.affymax.com/

[Der.Eroberer]

Die nächste Entscheidung steht bereits Ende März an. Omontys könnte dann auch in Europa zugelassen werden. Finde das aktuelle Niveau wieder kaufenswert.

[Schablonski]

Heftiger Absturz heute...
Wo bleiben die üblichen Spekulanten hier ???

[Schablonski]

Gibt es heute schon einen fetten Rebound ?
Oder ist es noch zu früh...
ich bin gespannt

[ElfenbeinelaufenschnellermitKo]

#1 Vielleicht kommt´s heuer wieder genauso?

Zitat von MrRipley: Heute wird gemeldet, dass ihnen Takeda 30 Millionen zahlt für eine pharmazeutische Entwicklung. Gestern noch gab es einen Kurssturz von ca 70%:





Shares of $180 million (market cap) biotech Affymax (AFFY) are plunging a whopping $14.87, or 65%, $8.13, after the company this morning announced results of Phase III trials for a drug under development called “Hematide,” for treating anemia, that seemed to cast doubt on the likelihood of FDA approval of the drug.

Raj Mehra of Auriga Securities, downgrading the shares to “Hold” from “Buy” this morning wrote that “The released data certainly puts the approval of Hematide in doubt at the moment, especially given the fact that Epogen and Aranesp (both of Amgen (AMGN) are) have adequately addressed the needs of the patients over the years.”

Mehra set a new $9 price target, based on a multiple of two times his projected year-end cash balance of $4.50 per share for AFFY.

[jameslabrie]

Antwort auf Beitrag Nr.: 44.186.968 von Schablonski am 26.02.13 11:27:59

nee weiter abwaerts!fuer 1 einstieg noch zu frueh...

[hansa0815]

Zitat von jameslabrie: nee weiter abwaerts!fuer 1 einstieg noch zu frueh...

Voll krass Alder!! Woher weisch du dem? Hat dir dem korregd jemand aus Kaffeesatz gelesen?

[jameslabrie]

ueberleben die?

[wallfox5771]

Hallo,

habe meinen neu eröffneten Thread wieder schließen lassen (bzw. wird geschlossen), hatte nicht gesehen, dass Dieser hier schon existiert.

Bin mit einer ersten kleinen Position eingestiegen.


Gruß an Alle hier!


Wallfox

[MrNutz]

und ihr meint das dieser wert noch überlebt ??
was führte zum absturz des kurses ???

[ElfenbeinelaufenschnellermitKo]

Steht hier:
http://www.stockpickr.com/5-stocks-poised-breakouts.html-25?…

Affymax



One stock that’s trending within range of triggering a near-term breakout trade is Affymax (AFFY), a biopharmaceutical company committed to developing novel drugs to improve the treatment of serious and often life-threatening conditions. This stock has been destroyed by the sellers so far in 2013, with shares off by a whopping 85%.

Shares of AFFY were pounded lower by 85% on Monday after reports of severe allergic reactions in some kidney-disease patients, culminating in at least five deaths, prompted the firm to recall its flagship antianemia drug Omontys.


If you take a look at the chart for Affymax, you’ll see that this stock gapped down huge on Monday with massive downside volume, from over $16 to its recent low of $2.34 a share. Following that gap down in price, shares of AFFY have rebounded slightly to its recent high of $2.82 a share. This stock has now entered extremely oversold territory, since its current relative strength index reading is 11.33. Oversold can always get more oversold, but it’s also an area where a stock can experience a powerful bounce higher from.

Traders should now look for long-biased trades in AFFY if it manages to break out above some near-term overhead resistance at $2.82 a share high volume. Look for a sustained move or close above $2.82 a share with volume that hits near or above its three-month average action of 2.41 million shares. If that breakout triggers soon, then I expect to see a very large tradable bounce that could easily spike shares of AFFY by 30% to 40%.

Traders can look to buy AFFY off any weakness to anticipate that breakout and simply use a stop that sits just below $2.34 a share. One could also buy off strength once AFFY takes out $2.82 a share with volume and then simply use a stop that that’s a reasonable percentage from your entry.

[ElfenbeinelaufenschnellermitKo]

Heute noch über 4?

Short Squeeze wenn ich nicht irre.

[Mutzinger]

Antwort auf Beitrag Nr.: 44.227.147 von ElfenbeinelaufenschnellermitKo am 07.03.13 19:10:03

Egal wie, was, wo !!! Hauptsache uuupp !!!

Das kesselt heute !!!!

Gruß Mutzi

[Earthfire]

Bin auch heute nachmittag noch zeitig rein.....

Squeeze ist klar....aber bei dem Volumen !!

die Frage ist...ob sich etwas an der Situation hier geändert hat bzw...eine positive News eintrudelt ?

In USA (in den Boards) wird diesbezüglich spekuliert

[ElfenbeinelaufenschnellermitKo]

In meinen Augen hat AFFY ganz klar zu tief gestapelt, um sich in ein schlechteres Licht zu rücken als sie sind.
Es wird ja nicht ewig dauern zu prüfen, woran oder an welcher Kombination/Mix diese Leute wirklich gestorben sind.
Sollte das korrogiert werden können etc. und die Entschädigungen stehen, ist der alte Kurs wieder in greifbarer Nähe.

[Stockfinder]

wenn man sich das Handelsvolumen anschaut (120% der gesamten ausstehenden Aktien der company) würde es mich nicht wundern, wenn es heute weiter nach oben geht! So ein shortsqueeze geht meist ein Stück weiter als man denkt!

[Stockfinder]

3,85 vorbörslich - denke wir gehen heute deutlich über 4 $ - da scheint weiter massiv Druck auf dem Kessel zu sein und die shorties müssen gewaltig achtsam sein....

[Earthfire]

Antwort auf Beitrag Nr.: 44.230.050 von Stockfinder am 08.03.13 13:34:03

Na der Squezze wurde erst mal gestoppt....

Obwohl ich sagen muss, das ich mir für den Fall das es zu massiven Gewinnmitnahmen kommt, das Down heftiger vorgestellt habe...

Im Aftermarket hat Sie auch noch mit einem geringen Plus geschlossen.

Ich tippe mal auf einen weiteren Anstieg in der nächsten Wochen....

Sehr interessanter Trade am Nasdaq in der letzten Sekunde (Kauf aus dem ASK ):

16:00:00 $ 3.29 39,966
15:59:59 $ 3.27 410

Read more: http://www.nasdaq.com/symbol/affy/time-sales#ixzz2N84cU2eT

Was mich stutzig macht, ist dieses enorme Handelsvolumen !?
Kenne ich sonst nur von einer Dilution...aber dann würde der Kurs anders aussehen bzw. gibt auch kein SEC-Filing hierzu.
Evtl ein Buyout ?

Rein vom Bauch her, würde ich sagen...irgendwas ist hier am köcheln

Schönes Rest WE ....und Toi Toi Toi

[ElfenbeinelaufenschnellermitKo]

charttechnisch denke ich morgen, massiv auf 3 oder darunter und dann weiter up.

[Earthfire]

Zitat von ElfenbeinelaufenschnellermitKo: charttechnisch denke ich morgen, massiv auf 3 oder darunter und dann weiter up.

Na da bin ich mal gespannt auf den Handelsverlauf morgen...

könntest richtig liegen ...allerdings sind die letzten Candles nicht recht zuverlässig.....obwohl der Trend einen bearishen Verlauf vorhersagt
Ich denke das es bei einer starken Nachfrage zum Covern weiterer Shorts kommen könnte...
Evtl. haben viele nach dem Volumen auf News gewartet...die sind nicht eingetroffen bis dato.....dies könnte drüben natürlich auch zu einem massiven Verkaufen führen, da einige noch gut im Plus sein dürften.



Ich werde mal den Premarket abwarten....und dann evtl. raus....oder auch nicht

[Earthfire]

Zitat von ElfenbeinelaufenschnellermitKo: charttechnisch denke ich morgen, massiv auf 3 oder darunter und dann weiter up.

Moin, ohne jegliche fundamentale Begründung bzw. auch wenn fast alle Indikatoren auf Rot stehen......ich tippe auf einen Nordkurs für heute !

mein Tipp....heute geht es über die 4 $
Mal sehen ob mein Bauch zuverlässiger wie die CT ist....

[ikarusfly]

Antwort auf Beitrag Nr.: 44.236.654 von Earthfire am 11.03.13 11:26:57

trotz einer steigung von über 70%(massive volumen)....gab es am montag einen rücksetzter von 6% und das unter absolut niederigen volumen. für mich ganz klar heute sk oberhalb der 4$ marke

[Promethium]

Antwort auf Beitrag Nr.: 44.234.510 von Earthfire am 10.03.13 11:02:54

Ja, hoffentlich keine Verwässerung!
Dann sehe ich Chancen auf eine technische Erholung.
Die gab's ja schon in der Vergangenheit mehrfach und das satt.

[ikarusfly]

Antwort auf Beitrag Nr.: 44.236.952 von Promethium am 11.03.13 12:37:38

die haben doch genügend cash...... bei dem amis gehen die von einem takeover aus entweder rocher oder pfitzer

[Earthfire]

Zitat von ikarusfly: die haben doch genügend cash...... bei dem amis gehen die von einem takeover aus entweder rocher oder pfitzer

Hi Ikarusfly,
die Amis gehen von vielen Möglichkeiten aus.....

Auch ein "back to the market" wird von vielen für möglich gehalten.

Cash ist genug da....da stimme ich dir zu.

Eine Übernahme schliesse ich auch nicht aus.....

Wenn wir nicht dieses enorme Volumen gehabt hätten...am Freitag dieses Minus von nur knapp 7 % ( Volumen war am Freitag ja auch nicht gerade wenig !).......dann hätte ich gesagt...kurzer Zock...mit dem entsprechenden Abverkauf...... kurzfristig.

Na ja...schaun wir mal was heute passiert

hier das Orderbuch :

http://datasvr.tradearca.com/arcadataserver/ArcaBookData.php…

[ikarusfly]

sieht jetzt echt beschissen aus.......

[Earthfire]

Zitat von ikarusfly: sieht jetzt echt beschissen aus.......

bin bei Eröffnung rausgegangen.....sonst geht mir noch mein Gewinn flöten

Positioniere mich mal knapp unter der drei....für einen Wiedereinstieg

[oli234]

Denke die 3$ halten..

[Earthfire]

Zitat von oli234: Denke die 3$ halten..

sieht momentan danach aus.....aber zu einem kurzen Peak abwärts unter die 3$ kann es jederzeit kurzfristig kommen....

[oli234]

Wenn die wieder richtung 2.50$ läuft stocke ich nochmal auf.Auf längere sicht sind bestimmt 5$ mal drin

[Earthfire]

Zitat von oli234: Wenn die wieder richtung 2.50$ läuft stocke ich nochmal auf.Auf längere sicht sind bestimmt 5$ mal drin

Schwierig zu sagen, wo das hier enden wird....je nach Newslage.

Lange bleibe ich hier nicht drin.....aber zum Traden ist AFFY derzeit..Top !

[oli234]

Bin leider mit Kaufkurs 3,7$ dabei

[Earthfire]

Zitat von oli234: Bin leider mit Kaufkurs 3,7$ dabei

OK, ich war rel. zu Beginn des Squeeze dabei....hatte sie auf der WL

Das Problem ist hier halt.....keiner weiss bis dato und wo die Reise hingeht....ist noch alles offen...im positiven, wie im negativen Sinn !

[ikarusfly]

Antwort auf Beitrag Nr.: 44.237.948 von Earthfire am 11.03.13 15:59:17

hier haben die shorties das zepter fest in der hand......solange nichts neues verkündet wird, geht es down leider

[Gustl24]

habe AFFY letzte woche paar mal getradet...z.zt. an der seitenlinie...
kleiner tipp an die gemeinde: Mannkind scheint wieder heißer zu laufen
seit freitag...bin dort auch nicht (leider) investiert, kurs wird eh
in USA gemacht, hab ich im auge

[ElfenbeinelaufenschnellermitKo]

Ich denke, es könnte wieder up gehen.
Meine Charts sind undeutlich, was die 3 betrifft, wurden die 3 heute touchiert?

[Earthfire]

Zitat von ElfenbeinelaufenschnellermitKo: Ich denke, es könnte wieder up gehen.
Meine Charts sind undeutlich, was die 3 betrifft, wurden die 3 heute touchiert?

Ja, war das Tief !

[ElfenbeinelaufenschnellermitKo]

Das wird nichts mit der 3, wird gleich massiv weiter fallen

[Stockbroker1]

Wie hoch schätzt ihr die Wahrscheinlichkeit, dass Omontys von der FDA wieder "freigegeben" wird und dieses Medikament gleichzeitig die Zulassung für den europäischen Markt erhält? Wie lange werden die Untersuchungen hinsichtlich der Todesfälle in etwa dauern? Wer bestimmt letztendlich, was genau Ursache für die Todesfälle war?
Fragen über Fragen, wie schätzt ihr die augenblickliche Situation ein?

[Earthfire]

Antwort auf Beitrag Nr.: 44.240.738 von Stockbroker1 am 12.03.13 10:42:22

also..."Back to the market" wird unter Umständen durchaus mit einem Jahr beziffert !
noch ist der Stand so, das der Rückruf von AFFY selbst kam....und nicht von der FDA.
Aber die Untersuchung der genauen Umstände der Todesfälle wird Mmn nicht in ein paar Wochen über die Bühne sein.
Ich denke auch, das die derzeitige Situation eine Zulassung für Europa durch die EMA nicht erleichtern sondern eher erschweren wird.

Alles in allem, schwer einzuschätzen hier :

eine negative News kann jederzeit den Kurs auf einen Dollar bzw. sogar darunter fallen lassen.

Cash ist zwar vorhanden...aber wenn das einzige Zugpferd abhanden kommt...und dann noch die Klagen bezüglich der Todesfälle.

[Stockbroker1]

Antwort auf Beitrag Nr.: 44.240.954 von Earthfire am 12.03.13 11:23:31

Danke für deine Einschätzung.

[ikarusfly]

http://investorshub.advfn.com/boards/read_msg.aspx?message_i…


In Affymax's case, companion diagnostics could be used to ensure that the patient being treated was not hypersensitive to Omontys. This would thereby avoid adverse events, while providing the convenience-related benefits compared to Amgen Inc.'s (AMGN) Epogen." Although Arrayit s product line is impressive, at least on the company's website, investors should perform much research on this Pink Sheets listed company with $3.8 million in revenue for 2012 with net income of a loss of $199 thousand. The company's common shares are also illiquid at the moment with an average of less than 24 thousand shares traded daily for this $5.19 million market capitalization company. Although Arrayit could provide a possible means to evaluate the patients experiencing adverse events with regard to OMONTYS and a means to screen future patients, the company should only be considered as a speculative possibility unless more information can be presented by the company. However, such diagnostic tests do exist elsewhere and would likely be a huge part of the OMONTYS investigation moving forward and could help to determine whether OMONTYS was at fault or not, and what the next steps should be in regard to possibly returning the drug to the market.

Another major catalyst also "lies in wait" for Affymax. The company submitted a Marketing Authorization Application in early 2012 to the European Medicines Agency (EMA) for European marketing of OMONTYS for the treatment of anemia associated with chronic kidney disease (CKD) in adult patients on dialysis. Although unlikely to market OMONTYS in the EU until current issues are resolved, the pending decision is indeed something investors should consider as they make their decisions.


könnte was dran sein.

[Stockbroker1]

Eine spätere Zulassung für den europäischen Markt sollte meiner Meinung nach im Kurs schon eingepreist sein.

[jeo1]

Ich frage mich moementan was überwiegt: Chance oder Risiko bei einem Einstieg bei Affymax?

Bei ca. 99,9 % der behandelten Patienten hat das Medikament sehr gut und effizient gewirkt.

Meiner Meinung nach sollte es doch einen Weg geben, die Leute vorab auf Hypersensibilität gegenüber dem Produkt zu testen. Allergien und allergische Reaktionen auf alles und jeden sind weit verbreitet und können doch durch Tests vorab ausgeschschlossen werden. Ok, das ist mit Aufwand und damit Kosten verbunden, sollte jedoch machbar sein.

Weniger wahrscheinlich wird die Möglichkeit sein, nach der Auswertung der Daten der betroffenen Patienten, eine homogene Gruppe der allergisch reagierenden Patienten zu finden und damit ausschliessen zu können. Jedoch ist dies nicht ausgeschlossen.

Worst case ist, dass immer wieder zufällige Todesfälle auftreten.

Ich habe mir heute ein paar AFFY ins Depot gelegt und steige auch wieder bei Aeterna Zentaris - AEZS ein.

Aeterna hat nun endlich die gescheiterten und schon vorher erwarteten schlechten Nachrichten zu Perifosine in MM eingestanden und veröffentlicht. Nachdem der Kurs gestern um ca. 20% gefallen ist, sollte sich der Kurs bald wieder erholen. Der einfache Grund: Höchstwahrscheinlich und vom Management angekündigt, soll in diesem Monat noch die Zulassung eines Hormontests erfolgen.

Weiterhin habe ich auf meiner Watchlist folgende Werte:

CYTR, MNKD, ZGNX, ONTY, IPXL, RPXR, FOLD, PACB, ENZN

[easydogi]

Ich bin mal mit einer kleinen Posi rein.
Mal sehen was passiert.

[Stockbroker1]

Nun gehts aber plötzlich schön nach Norden in USA!

[Stockbroker1]

Die Shorties machen sich vor Angst in die Hose; das kann noch heftig werden heute oder die nächsten Tage.

[ikarusfly]

[easydogi]

Na, sieht doch gut aus. Scheint, als hätte ich zum richtigen Zeitpunkt gekauft.

[ElfenbeinelaufenschnellermitKo]

Wie erwartet unter 3 eröffnet, hätte zwar gedacht, dass der Eröffnungskurs tiefer(2,8 startet), aber egal, ab jetzt kanns weiter gehen.

[ikarusfly]

Antwort auf Beitrag Nr.: 44.242.175 von ElfenbeinelaufenschnellermitKo am 12.03.13 16:04:13

die wandert jetzt ohne gegenwehr unter die 3$marke...........bid =0 mit miniumsatz den kurs runter gedrückt, überhaupt keine buying power

[easydogi]

Ist das richtig, dass Morgen die Zahlen veröffentlicht werden?

[Earthfire]

Zitat von easydogi: Ist das richtig, dass Morgen die Zahlen veröffentlicht werden?

Lt dem was ich in den US Boards gelesen habe ja....aber ich habe nichts auf der HP von AFFY gefunden

[easydogi]

Morgen kommen die Zahlen.


http://www.therem.org/highly-traded-biotech-stocks-in-focus-…
Affymax, Inc. (NASDAQ:AFFY)’s price increased +1.33% to close at $3.05 in the last trading session with a previous 52-week high of $27.74. The company is expected to release quarterly report on Mar 14, 2013. The stock was trading on above-average volume. The stock traded at a volume of 12.14 million shares. The share price is now down 86.99% for the past three months. Latest closing price was -80.23% below its 50-day moving average and -83.10% below its 200-day moving average.

[ikarusfly]

scheint so als würden die zahlen, während der handelszeit veröffentlicht

[hansa0815]

Zitat von ikarusfly: scheint so als würden die zahlen, während der handelszeit veröffentlicht

Du scheinst keine Ahnung zu haben!
Zahlen werde in den USA nie während der Handelszeit bekanntgegeben!

[Earthfire]

Die Zahlen kommen am 28 März :


http://www.bloomberg.com/apps/ecal?date=20130328&strtpt=1&en…

Earnings Announcements: Mar 28, 2013


COMPANY EST. DATE PERIOD ENDING EST. / ACTUAL EPS


AFFYMAX INC 03/28/2013 12/2012 -0.57 / --

[easydogi]

In der Nachbörse über 56% im Minus.
Boaah... ich hatte heute mit den Gedanken gespielt, einen erneuten kurzen Zock zu wagen. Gut, dass ich es nicht gemacht habe.


Affymax, Inc. : Affymax Announces Reduction in Force to Align Resources Around Ongoing Product Investigation
03/18/2013| 05:35pm US/Eastern

Affymax, Inc. (Nasdaq: AFFY) today announced that it will reduce its workforce as part of a plan to focus the company's resources on the ongoing investigation of reported hypersensitivity reactions in patients receiving OMONTYS® (peginesatide) Injection following the nationwide voluntary recall of product from the market. This action will reduce the company's workforce by approximately 230 employees (or 75%), which includes its commercial and medical affairs field organizations as well as other officers and employees.

"I would like to sincerely thank all of our departing employees and recognize their important and valued contributions to the company," said John Orwin, chief executive officer of Affymax. "While this decision was extremely difficult, aligning and managing our limited resources around our product investigation is our most important priority."

The company also announced that it will retain a bank to evaluate strategic alternatives for the organization, including the sale of the company or its assets, or a corporate merger. The company is considering all possible alternatives, including further restructuring activities, wind-down of operations or even bankruptcy proceedings.
http://www.4-traders.com/AFFYMAX-INC-39433/news/Affymax-Inc-…

[easydogi]

(Reuters) - Drug maker Affymax Inc (AFFY.O) said it may consider selling itself or filing for bankruptcy among a range of strategic alternatives as it struggles with the recent recall of its sole commercial product, the anemia drug Omontys.

Shares of the company slumped over 50 percent to $1.34 in extended trade on Monday after being halted earlier.

Affymax also fired its chief commercial officer and slashed about 230 jobs, or about 75 percent of its workforce, as part of a plan to cut costs.

The company said on February 23 that it would recall Omontys, citing serious adverse events, including death, in patients taking the drug. The shares fell 85 percent on the news.

Affymax said it was shifting most of the activities related to the investigation of the recall to its partner Takeda Pharmaceutical Co Ltd (4502.T) as it could not estimate if it had enough financial resources to complete the probe.

"If the company and Takeda are unable to rapidly identify and rectify the causes of the safety concerns to the satisfaction of the FDA, which is highly uncertain, Omontys may be permanently withdrawn from the market," the company said.

Affymax reported cash balance of about $67 million as of February end. It had liabilities that included potential contract manufacturing organization commitments of up to an estimated $33 million and outstanding debt obligations of up to about $11 million under its existing credit facility.

It also expects to incur between $8 million and $10 million in costs related to the job cuts.

Shares of the company closed at $2.92 on the Nasadaq.


Bleiben am Ende 13 Mio Dollar und eine Firma ohne Produkt.
Die 1,30 Dollar in der Nachbörse werden morgen bestimmt noch weit unterschritten werden.

[takeProfit]

sieht nicht gut aus... Wird wohl bei dem leider noch weiter runter gehen!

[Stockbroker1]

Mensch bin ich froh das ich Freitag mit Minimalverlust raus gegangen bin. Hatte ursprünglich auf eine deutliche Kurserholung gesetzt, mein "Bauchgefühl" bezgl. Bedenken über die (Wieder)Zulassung von OMONTYS führte aber letztendlich zum Ausstieg.
Schade, was nützen jahrelange Testphasen eines Medikamentes und letztendlich sogar die Zulassung wenn es im nachhinein doch mehrere Todesfälle mit allergischen Reaktionen gibt. Das alles hat für mich ein "Geschmäckle".

[Earthfire]

Antwort auf Beitrag Nr.: 44.269.967 von Stockbroker1 am 19.03.13 10:16:48

Da haben ja einige bei uns Schwein gehabt.....ich habe gestern bis auf eine Miniposi alles verkauft und in YRC investiert

Allerdings tippe ich im Gegensatz zu manch anderem..auf eine Erholung des Kurses....kurzfristiger Daytraderzock....denke so 20 % könnten es werden.........

[Stockbroker1]

Antwort auf Beitrag Nr.: 44.270.005 von Earthfire am 19.03.13 10:22:30

20 % heute sind drin denke ich auch, nur ist das nicht meine Art zu spekulieren.

[Stockbroker1]

Antwort auf Beitrag Nr.: 44.270.005 von Earthfire am 19.03.13 10:22:30

haste soeben in Frankfurt zugeschlagen (547 Stücj zu 0,954 Euro)?

[willblueauf10]

Morgen all.
Heftiger Absturz hier. Hat jemand auf die schnelle ein paar Fakten?
Sind sie inso gefährdet ? Würde ja fast blind auf eine Erholung setzten bis die Amis eröffnen.
Aber bin ehrlich dazu hab ich mich nicht eingelesen....

[Earthfire]

Zitat von Stockbroker1: haste soeben in Frankfurt zugeschlagen (547 Stücj zu 0,954 Euro)?

Nein war ich nicht ...ich handele fast ausschließlich in USA
Ich habe ja noch eine kleine Posi....die haue ich erst im Falle einer Erholung raus.....

Was man nicht ausser Acht lassen sollte....es gibt zwar den Rückruf und die Klagen gegen AFFY.....aber das Medikament hat ein enormes Markpotenzial bzw. ist ein Blockbuster.

Es besteht noch die Phantasie, das ein Bigplayer die Bude übernimmt und enstprechend weiterentwickelt....um es später neu zu vermarkten.
Die Patente liegen nach wie vor bei AFFY.

aber reine Spekulation......mal schauen was die Amis anstellen...im Premarket geht es gerade weiter down

[lunatics]

Momentan kriegst du noch 1 Dollar. Ich fürchte bald wird es nichts mehr sein.
Was übernommen wird sind höchstens die Patente. Die werden für eine handvoll Dollar verscherbelt.
AFFY am Tropf. Es kommt die Sterbehilfe...

[easydogi]

So schnell kann es gehen.
Vor wenigen Wochen über eine halbe milliarde wert und jetzt nur noch paar Millionchen.

Ich bin mit nem Tausender nochmal rein. Bischen zocken.

[Aktienheld72]

Wie schätzt ihr die Lage hier ein? Es sieht fast so aus als ob sich jetzt ein Zock lohnen würde. Es sind noch finanzielle Mittel vorhanden, die Patente und nach wie vor läuft wohl der Absatz des Medikamentes. Die Wirkung ist ja auch sehr gut. Es muss nur untersucht werden warum und wie es zu den 3 Toten gekommen ist. Eigentlich keine soo schlechte Ausgangslage. Traue mich aber grad nboch nicht einzusteigen.

[Aktienheld72]

Bei ihub wird übrigens geschrieben das es keine short mehr zu kaufen/leihen gibt. Es sind zu viele im Markt. Erstmal müsse zurück gekauft werden. Könnte für einen Preisschub sorgen. Bin mal gespannt und werde gut beobachten.

[easydogi]

Sehe ich bei google finance richtig?
Vor oder nachboerse 1,60!!!

[Aktienheld72]

Antwort auf Beitrag Nr.: 44.275.080 von easydogi am 20.03.13 09:44:35

In der Tat könnte stimmen

http://www.google.com/finance?cid=707830

1.05
-1.87 (-64.04%)
Pre-market: 1.60 +0.55 (52.38%)



Es deutet einiges darauf hin das der Kurs heute steigen wird mit einer hohen Vola.

Vielleicht kaufe ichmir doch jetzt schon die erste Posi, nachher könnte es zu spät sein.

[Aktienheld72]

Antwort auf Beitrag Nr.: 44.275.080 von easydogi am 20.03.13 09:44:35

@easy Danke dir übrigens für den Hinweis!!

[Hobbyaktien]

So ich spiele hier auch mal mit einem kleinen Betrag mit, hab gerade ein paar zu 0,80 € bekommen.

Kann hier jemand schon mal für gleich einen Realtime US-Chart einstellen?

[berti40]

Quelle????

[berti40]

Antwort auf Beitrag Nr.: 44.276.300 von Hobbyaktien am 20.03.13 13:35:19

http://www.nasdaq.com/symbol/affy/real-time#.UUm7PTe3vEV

[Hobbyaktien]

Antwort auf Beitrag Nr.: 39.722.355 von MrRipley am 22.06.10 20:56:15

So ich bin wieder raus zu 0,97 in Stuttgart!

ich wünsche euch viel Erfolg und gönne es euch auch, wenn es noch höher geht.

Für mich ist dieser Zock vorbei.

Wünsche allen gute Trades.

Man sieht sich bestimmt wieder bei einem anderen Wert.

[easydogi]

Ich warte. Könnte noch lustiger werden.

[easydogi]

[willblueauf10]

Ich auch:-)

[Hobbyaktien]

Antwort auf Beitrag Nr.: 44.277.552 von easydogi am 20.03.13 17:12:52

Da könntest du recht haben, aber ich gehe lieber auf Nummer sicher.

Was hälst du denn von Spectrum?

[easydogi]

Antwort auf Beitrag Nr.: 44.277.588 von Hobbyaktien am 20.03.13 17:17:44

Ist ja auch okay. Bin auch öfters mal auf schnelle 10-20% aus. Nur hier habe ich nicht viel investiert, deswegen kann es ruhig noch weiter steigen.

Spectrum sagt mir nichts, aber werde ich mir vielleicht mal anschauen.

[easydogi]

Tageshoch. Scheint weiter zu gehen. Mal schauen.
Die 1,60 vom Premarket müssten erreicht werden. Wenn nicht heute, dann morgen.

[willblueauf10]

Na 1,60 sind's nicht geworden, aber auch nicht wieder zusammen gesackt. Vielleicht geht's heute ja drüber:-)
Morgen @ all

[berti40]

1,60 wurden im premarkt storniert!!

[berti40]

War wohl ein Fehler

[berti40]

Premarkt USA 1,32 USD

[willblueauf10]

1,50 sind wir schon , fehlen nur noch 8,50

[easydogi]

Ich bin erstmal raus. Muß bei 3W noch ein wenig nachlegen.

[willblueauf10]

Sollte es so bleiben , bin ich mehr als zufrieden :-)...

[willblueauf10]

Na hier geht's ja wieder gut ab !!
Und keiner ist da

[mucor]

Ich denke wir werden heute noch Kurse unter 1,30 sehen."Wochenende"!!

[mucor]

Antwort auf Beitrag Nr.: 44.288.064 von mucor am 22.03.13 18:14:19

Sollten die Shortis zurückkaufen müssen,gäbe es eine unglaublich gewaldige Preisexplosion nach oben."Könnte so kommen"!

[berti40]

09.04.2013 22:00:01 1,1400 200.830

[berti40]

zum schuss im USA Land
über 200000 Stück bei 1,14 USD gehandelt!!!!!

[kyron7htx]

Alle kurz vorher verkauft. Nur Loser hier, hahahaha.

[kyron7htx]

Wer Okt. 2012 rein ist, hat praktisch Totalverlust.

[mucor]

Sei mal nicht so sicher!Totgeglaubte können manchmal auferstehen.

[lunatics]

Zitat von mucor: Sei mal nicht so sicher!Totgeglaubte können manchmal auferstehen.

AFFY spricht von bankruptcy....ein gutes Zeichen ?

[Charly_2]

....kursgang gegen Null .. gibts noch shorts ?

[berti40]

Mensch Charly!
Du hast echt Ahnung!!!

[kyron7htx]

Antwort auf Beitrag Nr.: 44.397.889 von berti40 am 09.04.13 22:42:55

0,9403 $. No comment only pennystock

[berti40]

Noch lange nichts zu Ende!
Nur weil es ein paar Tage unter 1USD ist.
Das muss 30 Tage so sein und dann haben sie noch 90 TAge zeit bevor etwas passiert.
Bleib nur schön von dieser Aktie weg.
:-)
Besser für deine Nachtruhe.

[berti40]

Der Start nach oben kann beginnen!!

[ElfenbeinelaufenschnellermitKo]

und los gehts, wieviel Cash hatten die gleich nochmal?

[julic26]

was geht denn heute ab???

[ElfenbeinelaufenschnellermitKo]

http://seekingalpha.com/article/1409951-affymax-could-be-the…

[multimediaperle]

Antwort auf Beitrag Nr.: 44.584.151 von berti40 am 07.05.13 17:52:13

Hier wird weiter kräftig spekuliert
Hab meine Shares gestern verkauft Wünsche allen Investierten noch viel Glück u schönen Gewinn

[mucor]

Heute am Freitag gehe ich auch lieber eimal raus,da sichelich nach dem extremen Anstieg in den letzten Tagen Gewinnmitnahmen ein Thema sein werden.

[Earthfire]

Typische Amifalle...im Aftermarket gibt Affy gerade unter hohem volumen alle Prozente wieder ab !!!

[Hamburgspook]

Antwort auf Beitrag Nr.: 44.762.755 von Earthfire am 31.05.13 22:37:12

Mit Grund...
http://www.streetinsider.com/Corporate+News/Affymax+(AFFY)+H…

[Tommi33]

Zitat von Earthfire: Typische Amifalle...im Aftermarket gibt Affy gerade unter hohem volumen alle Prozente wieder ab !!!

Also ich weiss jetzt nicht was du unter hohem Volumen verstehst, aber wenn ich auf Nasdaq.com schaue sehe ich im normalen Handel 35,161,362 Shares gehandelt und im After Market Handel 2,480,202 Shares. Das 50 Day Avg. Daily Volume beträgt 6,880,562.

Quelle: Nasdaq.com

[Earthfire]

Zitat von Tommi33:

Zitat von Earthfire: Typische Amifalle...im Aftermarket gibt Affy gerade unter hohem volumen alle Prozente wieder ab !!!

Also ich weiss jetzt nicht was du unter hohem Volumen verstehst, aber wenn ich auf Nasdaq.com schaue sehe ich im normalen Handel 35,161,362 Shares gehandelt und im After Market Handel 2,480,202 Shares. Das 50 Day Avg. Daily Volume beträgt 6,880,562.

Quelle: Nasdaq.com

Morgen---ganz einfach....für den PRE oder Aftermarket ist dies ein verhältnissmässig hohes Volumen !

Oft geht es im after auch mal groß down...mit 100k oder so...dies wäre nicht viel...aber dies gestern---war in meinen Augen viel !

Wenn du eine andere Meinung hast...ist dies auch OK

Ich habe gestern Mittag überlegt..Fannie oder AFFY zu zocken...habe mich für Fannie entscheiden...Schwein gehabt !

schönes WE

[Earthfire]

Zitat von Hamburgspook: Mit Grund...
http://www.streetinsider.com/Corporate+News/Affymax+(AFFY)+H…

alter Hut...vom 28/5

Das war eine Zockfalle gestern....und im Aftermarket...haben einige Kasse gemacht !

[Hamburgspook]

Antwort auf Beitrag Nr.: 44.763.969 von Earthfire am 01.06.13 09:55:06

Kein alter Hut und Zocker Falle. Das Statement war am 28.05 an Affy, offiziell wurde es aber erst Freitag 22.15 CET verkündet. Das wusste ausser ein paar Insidern keiner. Bin sehr gespannt wie es heute weiter geht. Sieht nach Blutbad aus, Short Quote aber auch sehr hoch. Müssen die bis Delisting Covern oder geht das auch an der OTC mit den gleichen Aktien ?

[Earthfire]

Zitat von Hamburgspook: Kein alter Hut und Zocker Falle. Das Statement war am 28.05 an Affy, offiziell wurde es aber erst Freitag 22.15 CET verkündet. Das wusste ausser ein paar Insidern keiner. Bin sehr gespannt wie es heute weiter geht. Sieht nach Blutbad aus, Short Quote aber auch sehr hoch. Müssen die bis Delisting Covern oder geht das auch an der OTC mit den gleichen Aktien ?

Hi, ok wenn dies erst Freitag 22:15 verkündet wurde hast du vollkommen Recht.
Da ich nicht investiert bin...habe ich mich nur oberflächlich damit beschäftigt...dh die News und das chart...mehr nicht !

Ja shit happens....sieht böse aus...

An der OTC werden meines Wissens die gleichen Shares gehandelt..allerdings wenn du in Deutschland einen Tradinghalt hast...können die Amis ein paar Tage in der Regel vorher nach Handelsaufnahme handeln...dh. man schaut unter Umständen hier zu .....wie die den Kurs runterprügeln..ohne Handeln zu können...übel !

Bei den Puts kommt es auch ...auf den Coverdate an !!
Schwer zu sagen was passiert....Affy wird wohl auch an der OTC ein interessantes Zockpapier bleiben !

[Hamburgspook]

Antwort auf Beitrag Nr.: 44.771.671 von Earthfire am 03.06.13 09:57:18

Danke Earth für Deine Antwort.
Das war das gruseligste Börsenwochenende meines Lebens. Bin an der NASDAQ am Freitag schön in den Aufwärtstrend mit 10k rein. Hab eigentlich mit einem Open Gap am Montag gerechnet. Sah sehr gut aus, dann kam die Meldung über Delisting an der NASDAQ nach Börsenschluß und konnte zusehen wie das Teil 35 % im After Market abgeschmiert ist. In DE konnte ich auch nichts verkaufen und konnte gerade zu 1,68 raus. Ich dachte wir starten gleich unter einem Dollar. Fazit für mich, ich gehe jetzt überall raus vor dem WE, so etwas will ich nicht nochmal erleben. Happy Trading

[ElfenbeinelaufenschnellermitKo]

Der Affe geht ab.
Ich will nicht bestreiten, ob alle Shorts vor dem 6. geschlossen werden müssen. Drüben streiten sie drüber, die einen meinen nach Rücksprache mit Börse und Brokern, ja, die anderen nein.

Meine Erfahrung ist, dass die Shorts nicht gecovert werden mpüssen.

Jedoch liegt die Gefahr in der Luft, dass während des "Umzugs" an die OTC so manch erdenkliche News bzgl Takeda bzw über einen mgl. buyout an die Öffentlichkeit gelangen könnte, so dass heutige SDhorts in den Arsch gekniffen sein könnten.

Meine Erfahrung ist auch, dass ein Delisting/Listing an der OTC nicht für einen weiteren Kursabfall sorgen muss, sofern gewisse Dinge klar sind, wie etwa Cashstand und abgewendete Ch11 Gefahr usw.
Ein Delisting war jedenfalls sonnenklar, wie der heutige Kurs schon sagt, eine kurze Panikreaktion.

[Earthfire]

Zitat von Hamburgspook: Danke Earth für Deine Antwort.
Das war das gruseligste Börsenwochenende meines Lebens. Bin an der NASDAQ am Freitag schön in den Aufwärtstrend mit 10k rein. Hab eigentlich mit einem Open Gap am Montag gerechnet. Sah sehr gut aus, dann kam die Meldung über Delisting an der NASDAQ nach Börsenschluß und konnte zusehen wie das Teil 35 % im After Market abgeschmiert ist. In DE konnte ich auch nichts verkaufen und konnte gerade zu 1,68 raus. Ich dachte wir starten gleich unter einem Dollar. Fazit für mich, ich gehe jetzt überall raus vor dem WE, so etwas will ich nicht nochmal erleben. Happy Trading

Hallo...bei Zockpapieren...stelle ich immer zum Handelsschluss glatt..am Nadaq...gerade wegen dem Aftermarket !

Bei der OTC gibt es keinen Aftermarket...da kannst du dann halten !

[mucor]

Wird am Montag der Handel wieder aufgenommen?Könnte eine heftige Gegenreaktion nach oben erfolgen.(natürlich nur kurzfristig!).

[mucor]

Bis wann wird man Affymax wieder handeln können?

[mucor]

Antwort auf Beitrag Nr.: 44.819.985 von mucor am 10.06.13 15:54:36

Vielen Dank für die zahlreichen Antworten!Na ja,ich gehe davon aus,dass keiner weiss,wann es weitergeht.

[multimediaperle]

Antwort auf Beitrag Nr.: 44.821.257 von mucor am 10.06.13 18:34:17

http://www.google.com/finance?q=OTCMKTS%3AAFFY&ei=fhO2UeiVJe…

[mucor]

Vielen Dank multimediaperle!Heute geht Affy ja ab wie eine Rakete an der OTC.Schon über 20% nach oben!!

[berti40]

Hi!
Affymax lebt noch.
:-)

[holdriho]

moin zusammen. Bin durch Zufall hierher geraten und sehe, dass heute wieder was geht bei AFFY..
Weis jemand was genaueres???

[Schablonski]

Nun scheint mir noch nacht alles vorbei hier. Immerhin wird ja eine AUszahlung eines Verwertungsbetrags in Aussicht gestellt. Das ist doch mehr als man bei vielen anderen Klitschen zu erwarten hat.
Hier kann man nochmal mit spekulieren.

[Schablonski]

steigt !!!

[Schablonski]

Antwort auf Beitrag Nr.: 47.215.366 von Schablonski am 26.06.14 16:08:12

Die Aktie hat sich gestern in den USA gut gehalten. Zum Verkaufen hat ja aktuell niemand mehr einen Grund, daher kann man hier noch spekulieren das sie nochmal ein paar Cent steigt.