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Geron mit Hammernews!! (Seite 268)



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Modified Endpoint Paves Way For Geron's iMerge / MDS Trial Accelerated Approval
May 3, 2018 12:16 PM ET|


Today's clinical trial update paves the way for Accelerated Approval for Imetelstat in MDS.
The Johnson and Johnson (JNJ) iMerge trial testing Geron's (GERN) Imetelstat for Myelodysplastic Syndrom "MDS" was updated today to use PFS (progression free survival) as a secondary endpoint. This likely will pave the way for Accelerated Approval in MDS later this year.


Next week's conference will confirm full speed ahead for JNJ/Geron Collaboration agreement.

Significant updates can come next week at the Deutsche Bank 43rd Annual Health Care Conference where Mathai Mammen, MD, Ph.D., Global Head, Research & Development, Janssen Research and Development will be presenting. This could get REALLY REALLY fun folks!!!


Major boost could be coming on May 15th at the annual meeting.
Geron's annual meeting will likely confirm the path forward for Imetelstat and shares are likely to ramp up ahead of the meeting. I'll be offering a more detailed overview and what to look for in an upcoming article published here on Seeking Alpha!

https://seekingalpha.com/instablog/3163201-medtechbio/515407…
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Antwort auf Beitrag Nr.: 57.693.186 von bernie55 am 04.05.18 10:13:23
Zitat von bernie55: Modified Endpoint Paves Way For Geron's iMerge / MDS Trial Accelerated Approval
May 3, 2018 12:16 PM ET|


https://clinicaltrials.gov/ct2/history/NCT02598661?A=1&B=28&…
UPCOMING EVENTS

43rd Annual Health Care Conference
Please Save the Date for the Deutsche Bank 43rd Annual Health Care Conference on Tuesday, May 8 and Wednesday, May 9, 2018, at the InterContinental Boston Hotel.

https://www.db.com/newsroom_news/2018/43rd-annual-health-car…




Geron Corporation (Nasdaq:GERN) will hold its 2018 Annual Meeting of Stockholders , on Tuesday, May 15, 2018, at 4:00 p.m. PDT.

http://ir.geron.com/news-releases/news-release-details/geron…
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Antwort auf Beitrag Nr.: 57.693.312 von bernie55 am 04.05.18 10:28:36
Zitat von bernie55: UPCOMING EVENTS

43rd Annual Health Care Conference
Please Save the Date for the Deutsche Bank 43rd Annual Health Care Conference on Tuesday, May 8 and Wednesday, May 9, 2018, at the InterContinental Boston Hotel.

https://www.db.com/newsroom_news/2018/43rd-annual-health-car…



Geron Co. (GERN) Shares Bought by Deutsche Bank AG

Posted by Emily Bradson on May 5th, 2018

Deutsche Bank AG increased its stake in Geron Co. (NASDAQ:GERN) by 70.1% during the fourth quarter, according to its most recent filing with the SEC. The fund owned 696,410 shares of the biopharmaceutical company’s stock after buying an additional 286,979 shares during the quarter. Deutsche Bank AG owned 0.44% of Geron worth $1,251,000 at the end of the most recent quarter.

Insgesamt dann also 983,389 Shares.....:eek:

https://www.marketbeat.com/scripts/SECFilingChart.ashx?Prefi…
SEC makes rule on 'naked' short-selling permanent
By MARCY GORDON - BUSINESS WRITER WASHINGTON


Die SEC will neue Maßnahmen gegen die sog. Leerverkäufe ergreifen. Diese sollen u.a. Verkaufsaktionen verhindern, die sich von selbst finanzieren ( Uptick rule )- oder auch Leerverkäufe für den Rest einer Handelssitzung verbieten, die um 10 % oder mehr zurückgeht.

Dann bin ich mal gespannt,ob diesen Worten wirklich Taten folgen werden.



Federal regulators on Monday made permanent an emergency rule aimed at reducing abusive short-selling, put in at the height of last fall's market turmoil.
The Securities and Exchange Commission announced that it took the action on the rule targeting so-called "naked" short-selling, which was due to expire Friday.
Short-sellers bet against a stock. They generally borrow a company's shares, sell them, and then buy them when the stock falls and return them to the lender — pocketing the difference in price.
"Naked" short-selling occurs when sellers don't even borrow the shares before selling them, and then look to cover positions sometime after the sale.
The SEC rule includes a requirement that brokers must promptly buy or borrow securities to deliver on a short sale.
At the same time, the SEC has been considering several new approaches to reining in rushes of regular short-selling that also can cause dramatic plunges in stock prices.
Investors and lawmakers have been clamoring for the SEC to put new brakes on trading moves they say worsened the market's downturn starting last fall. SEC Chairman Mary Schapiro has said she is making the issue a priority.
The five SEC commissioners voted in April to put forward for public comment five alternative short-selling plans. One option is restoring a Depression-era rule that prohibits short sellers from making their trades until a stock ticks at least one penny above its previous trading price. The goal of the so-called uptick rule is to prevent selling sprees that feed upon themselves — actions that battered the stocks of banks and other companies over the last year.
Another approach would ban short-selling for the rest of the trading session in a stock that declines by 10% or more.
In addition to making the "naked" short-selling rule permanent, the SEC and its staff are working with major stock exchanges to make data on short-sale transactions and volumes publicly available through the exchanges' websites, the SEC announcement said. It will result in "a substantial increase" over the amount of information currently required, the agency said.
"Today's actions demonstrate the (SEC's) determination to address short-selling abuses while at the same time increasing public disclosure of short-selling activities that affect our markets," Schapiro said in a statement.

https://abcnews.go.com/Business/story?id=8186474&page=1
Antwort auf Beitrag Nr.: 57.693.312 von bernie55 am 04.05.18 10:28:36

Press Release

Geron 2018 Annual Meeting of Stockholders to be Held on May 15


MENLO PARK, Calif., April 17, 2018 (GLOBE NEWSWIRE) -- Geron Corporation (Nasdaq:GERN) will hold its 2018 Annual Meeting of Stockholders, on Tuesday, May 15, 2018, at 4:00 p.m. PDT.

>>MEZ 16.05.18 - 01.00 Uhr
<<


http://ir.geron.com/news-releases/news-release-details/ger…



Geron Announces Oral Presentation at European Hematology Association Congress

Updated Imetelstat Clinical Data from Part 1 of IMerge in Myelodysplastic Syndromes to be Presented
MENLO PARK, Calif., May 17, 2018 (GLOBE NEWSWIRE) --

Geron Corporation (Nasdaq:GERN) today announced that an abstract describing clinical data regarding the telomerase inhibitor imetelstat has been selected for an oral presentation at the 23rd Congress of the European Hematology Association (EHA) to be held in Stockholm, Sweden from June 14-17, 2018.

The abstract was published today on the EHA website at https://ehaweb.org/congress.

Title: Imetelstat in RBC Transfusion-Dependent (TD) Lower Risk MDS Relapsed/Refractory to Erythropoiesis-Stimulating Agents (ESA) (IMerge): Updated Efficacy and Safety
Abstract Number: S1557
Date: Sunday, June 17
Time: 8:30-8:45 am CET

The abstract contains updated data (as of January 2018) from the first 32 patients enrolled in Part 1 of IMerge, the ongoing Phase 2/3 clinical trial of imetelstat in patients with lower risk myelodysplastic syndromes (MDS) being conducted by Janssen Research & Development, LLC.

In accordance with EHA policies, abstracts submitted to the Annual Congress of EHA are embargoed from the time of submission. To be eligible for presentation at the Annual Congress of EHA, any additional data or information to be presented at the Annual Congress may not be made public before the presentation.

Following the Annual Congress of EHA, the presentation slides will be available in the “R&D” section of Geron’s website www.geron.com.

http://ir.geron.com/news-releases/news-release-details/geron…
1 Antwort?Die Baumansicht ist in diesem Thread nicht möglich.
Meine Erkenntnis ist das der Ceo von Geron ein Verkäufer ist.Hat er schon oft gemacht.Jetzt macht er Geron hübsch und etwas unabhängig um den besten Preis herauzubekommen.Das ist mein Eindruck von der Jahres Konferenz.
Klares Indiz das die Kooperation fortgesetzt wird:


IMETELSTAT IN RBC TRANSFUSION-DEPENDENT (TD) LOWER RISK MDS RELAPSED/REFRACTORY TO ERYTHROPOIESIS-STIMULATING AGENTS (ESA) (IMERGE): UPDATED EFFICACY AND SAFETY
Author(s): Pierre Fenaux
, Azra Raza
, Edo Vellenga
, Uwe Platzbecker
, Valeria Santini
, Irina Samarina
, Koen Van Eygen
, María Díez-Campelo
, Mrinal M. Patnaik
, Laurie Jill Sherman
, Libo Sun
, Helen Varsos
, Esther Rose
, Aleksandra Rizo
, David P. Steensma
(Abstract release date: May 17, 2018) EHA Learning Center. Fenaux P. Jun 17, 2018; 214476
Pierre Fenaux
Pierre Fenaux
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Abstract
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Abstract: S1557

Type: Oral Presentation

Presentation during EHA23: On Sunday, June 17, 2018 from 08:30 - 08:45

Location: Room A4

Background
Patients with lower-risk MDS that is relapsed/refractory to ESA have few treatment options. The first-in-class telomerase inhibitor imetelstat, which targets cells with short telomere lengths and active telomerase, has the potential to provide clinical benefit in this patient population.

Aims
Here we report updated safety and efficacy data from IMerge, an ongoing 2-part, global, phase 2/3 study of imetelstat in RBC TD patients with IPSS Low or Intermediate-1 (Int-1) risk MDS.

Methods
The IMerge population includes patients with MDS relapsed/refractory to ESA with a transfusion requirement of ≥4 units over 8 weeks prior to entry and ESA-naïve patients with sEPO >500 mU/mL. In Part 1 (open-label, single-arm), imetelstat 7.5 mg/kg was administered IV every 4 weeks (escalation to 9.4 mg/kg permitted after 3 cycles). The primary endpoint is the rate of RBC transfusion-independence (TI) lasting ≥8 weeks; secondary endpoints include safety, ≥24-week TI rate, time to and duration of TI, and hematologic improvement (HI) rate. Updated results for the first 32 patients enrolled in Part 1 (median follow up, 75.3 weeks) are reported here.

Results
Median age was 68.5 years. 59% of patients were IPSS Low and 41% Int-1. 13 patients (43%) had sEPO>500 mU/mL. 34% had a cytogenetic abnormality, including 22% with del(5q). Prior MDS treatments included ESAs (88%), lenalidomide (38%), and decitabine or azacitidine (HMAs) (25%); 41% were both lenalidomide and HMA naïve and non-del(5q). As of Jan 2018, RBC-TI ≥8-week was achieved in 38% of patients. Median time to onset of TI was 8 weeks with a median duration of TI of 23 weeks. 16% of patients achieved ≥24-week TI, and 63% achieved erythroid HI. Of 13 lenalidomide and HMA naïve and non-del(5q) patients, 54% achieved ≥8-week TI. Median time to onset of TI in the subset was 8 weeks with a median duration of TI of 43 weeks. 31% of these patients had ≥ 24-week TI, and 69% achieved erythroid HI. TI response did not differ based on the presence of ringed sideroblasts or baseline sEPO level (41% [7/17] ≤500 mU/L; 38% [5/13] >500 mU/L). Cytopenias, particularly neutropenia and thrombocytopenia, were the most frequently reported adverse events (AEs) overall and in the lenalidomide/HMA naive and non-del(5q) subset. The subset had a lower incidence of gr ≥3 neutropenia relative to the overall population (54% vs 66%) but a higher rate of gr ≥3 thrombocytopenia (62% vs 53%). Gr 4 neutropenia incidences were 41% overall and 38% for the subset. Overall, 28 patients (88%) had reversible LFT elevations by at least one grade. Four patients had gr 3 worsening of AST and/or ALT (1 also had gr 3 worsening of bilirubin), all of which were reversible. Eleven patients received growth factors during the study for treatment of an AE or ongoing medical history (n=10) or as prophylaxis (n=1).

Conclusion
Safety and efficacy reported here support continued investigation of imetelstat using the current dosing regimen of 7.5 mg/kg every 4 weeks in IPSS Low/Int-1 RBC TD MDS patients relapsed/refractory to ESA. AEs (mostly cytopenias) were predictable, manageable, and reversible. TI was observed in 38% and erythroid HI in 63% of patients with imetelstat therapy, with a 16% durable 24-week TI rate. Patients naïve to lenalidomide and HMAs and who lacked del(5q) had a 54% 8-week TI rate and responses were more durable (31% 24-week TI rate). To further validate these findings, additional patients meeting these criteria have been enrolled and are currently being followed.

Session topic: 10. Myelodysplastic syndromes – Clinical

Keyword(s): Myelodysplasia, Telomerase
Warum Geron Corporation Stock erhitzen
Motley Narr
George Budwell, Der Motley Narr
,Motley Fool •23. Mai 2018
Was ist passiert
Die Aktien der Biotech- Geron Corporation (NASDAQ: GERN) im klinischen Bereich sind am zweiten Tag in Folge ohne erkennbare Nachrichten zweistellig gestiegen . Was ist los?

Während das Unternehmen diese Woche keine wesentlichen Nachrichten veröffentlicht hat, um diesen plötzlichen Anstieg zu erklären, könnte Gerons Aktie auf zwei aktuelle Entwicklungen reagieren:

Der Kongress verabschiedete heute ein so genanntes "Right-to-try" - Gesetz, das todkranken Patienten den Weg ebnen könnte, mit dem First-in-Class-Telomeraseinhibitor Imetelstat des Unternehmens als letztes Mittel zu experimentieren.
Geron und sein Partner Johnson & Johnson (NYSE: JNJ) gaben am vergangenen Donnerstag bekannt, dass die imetelstat-Studie zu niedrigeren Risikofaktoren für myelodysplastische Syndrome (MDS) für eine mündliche Präsentation auf dem 23. Kongress der European Hematology Association im Juni ausgewählt wurde.
Ein kränklicher Mann im Bett, umgeben von seiner erwachsenen Frau und seinem Mann.
Ein kränklicher Mann im Bett, umgeben von seiner erwachsenen Frau und seinem Mann.
Mehr
Bildquelle: Getty Images.

Gerons Aktie ist derzeit um 13% gestiegen, und zwar um 11:44 Uhr EDT.

Na und
Vor der Rallye dieser Woche hatten die Geron-Aktien Schwierigkeiten, einen Tiefpunkt zu finden, nachdem das Unternehmen im letzten Quartal beschlossen hatte, rund 50 Millionen Dollar Kapital aufzubringen, falls J & J beschließt, ihre laufende Blutkrebs-Zusammenarbeit zu beenden. Mit der bevorstehenden mündlichen Präsentation, die jetzt auf dem Plan steht, sind die Anleger jedoch offenbar zuversichtlicher, dass J & J dabei bleiben wird.

Was jetzt
Das Hauptproblem hier ist, dass diese bevorstehende MDS-Präsentation ein umfangreiches Update bezüglich des Fortschritts von imetelstat in der erweiterten Untergruppe von Patienten enthalten sollte, die für eine Behandlung mit Lenalidomid und Hypomethylierung naiv sind und die Del (5q) -Mutation nicht aufweisen. Und da es sich um eine mündliche Präsentation und nicht einfach um ein Poster handelt, werden diese Daten wahrscheinlich beeindruckend sein. Mündliche Konferenzpräsentationen sind typischerweise nur für wesentliche Entwicklungen reserviert.

Während dieses Recht, Nachrichten zu versuchen, positiv ist, ist das wichtigste Ereignis, das im Auge behalten werden sollte, das IMETELSTAT MDS-Update beim nächsten Treffen der European Hematology Association. Bis dahin dürfte die Geron-Aktie in Erwartung dieses nächsten klinischen Fortschrittsberichts weiter steigen.
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