Tetraphase Pharmaceuticals, Inc. (TTPH) USD 7.55 - gekauft! - 500 Beiträge pro Seite

[Cyberhexe]

Pivotalstudie erfolgreich abgeschlossen - ein erster Überblick hat mich zum Kauf veranlasst:
http://ir.tphase.com/releasedetail.cfm?ReleaseID=1034372

[Cyberhexe]

Antwort auf Beitrag Nr.: 55.397.312 von Cyberhexe am 26.07.17 16:39:00

Heute 5000 Stück gekauft zu $6.39.

[paul81]

auch mit dabei

so habe mich kurz vor börsenschluss auch noch zu einem kleinen zock hinreissen lassen...

soviel zock sollte es eigentlich nicht mal sein, mk von 250 mio bei möglichen peak sales von 700 mio. bietet doch ein ordentliches potential für kurssteigerungen
--> http://www.reuters.com/article/us-tetraphase-outlook-ceo-idU…

die SAEs sehen auch ok aus, hoffe es wird nicht wie bei cempra am ende doch noch was gefunden, dass die zulassung stoppt

[Schaeffi]

Antwort auf Beitrag Nr.: 55.415.756 von Cyberhexe am 28.07.17 20:12:26

Tetraphase Announces Pricing of Public Offering of Common Stock

..hatte ich auch schon mal vor einiger Zeit auf dem SCHIRM diese AG


https://finance.yahoo.com/news/tetraphase-announces-pricing-…

wie so oft wird auch hier bei Guten News /Anstiegen die Chance zum Geld einsammeln genutzt
ist nervig aber legitim für die Forschende Bio Zunft.
d.h. erst mal unterschreiten des PO Preises auf längere Zeit bis alles verdaut ist

Hiermit wieder auf Watch

S.

[paul81]

Antrag für Zulassung bei EMA eingereicht

http://ir.tphase.com/releasedetail.cfm?ReleaseID=1037575

[DasTier666]

Tetraphase Pharmaceuticals to Present Data at IDWeek 2017

WATERTOWN, Mass., Sept. 25, 2017 (GLOBE NEWSWIRE) -- Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a clinical stage biopharmaceutical company developing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, today announced upcoming data presentations at Infectious Disease Week (IDWeek) 2017, taking place October 4-8 in San Diego, CA. In total, five presentations will be given including pharmacokinetic data from clinical studies supporting eravacycline's potential use in patients with renal or hepatic impairment as well as from the company's ongoing oral eravacycline development program.

http://ir.tphase.com/releasedetail.cfm?ReleaseID=1041541

[DasTier666]

1832. Impact of Meal Timing on Eravacycline Exposure During the Oral Portion of an IV to Oral Transition Dosing Regimen

Session: Poster Abstract Session: Clinical Study with New Antibiotics and Antifungals
Saturday, October 7, 2017
Room: Poster Hall CD

...
Conclusion:
These results support the conclusion that oral dosing in the previous phase 3 study resulted in low ERV exposures and urine concentrations. The exposures and urine concentrations observed with IV ERV are well within the expected therapeutic range and support the efficacy of IV ERV in the treatment of cUTI. Day 7 results in the fasted period indicate that an IV to oral transition dose regimen for ERV is achievable and work is ongoing to optimize dose and meal schedule.

https://idsa.confex.com/idsa/2017/webprogram/Paper66183.html

[DasTier666]

1209. In Vitro Activity of Eravacycline and Comparator Antimicrobials Against 143 Strains of Bacteroides Species.

Session: Poster Abstract Session: Expanded Spectrum - New Antimicrobial Susceptibility Testing
Friday, October 6, 2017
Room: Poster Hall CD

...
Conclusion: This study confirmed the improved activity of ERV over TGC against Bacteroides and suggests that ERV may be an appropriate choice for infections involving these organisms.

https://idsa.confex.com/idsa/2017/webprogram/Paper65669.html

[DasTier666]

Tetraphase Pharmaceuticals Presents Clinical Data from Oral Eravacycline Development Program at IDWeek 2017
Company plans to advance current oral eravacycline formulation into a phase 2 study in 1H18
Oct 4, 2017

...
"We are encouraged by the clinical data in healthy volunteers we have recently seen in the phase 1 oral eravacycline development program and are eager to initiate the next step of evaluating the optimized IV-to-oral dosing regimen in a patient population," said Guy Macdonald, President and Chief Executive Officer of Tetraphase. "In addition to establishing an oral dosing regimen, this phase 1 program has also confirmed that drug exposures and urine concentrations achieved with IV eravacycline are within the expected therapeutic range and support the efficacy of once-daily IV eravacycline in cUTI, which we are evaluating in the ongoing phase 3 IGNITE3 study. We look forward to topline data for IGNITE3 in the first quarter of 2018."

Patrick Horn, Chief Medical Officer of Tetraphase added, "Data from this phase 1 study presented at IDWeek confirm that the timing of oral dosing relative to meals drove the lower than expected drug exposures seen with the oral dosing regimen in IGNITE2, our first phase 3 IV-to-oral study in cUTI. Subsequent studies in this phase 1 oral program then evaluated different doses of eravacycline and varied meal time/dosing schedules. Results confirmed that increasing the interval between meals and dosing and administering a 250 mg oral dose of eravacycline produces drug exposures that we believe will be therapeutic in cUTI. With this optimized IV-to-oral dosing regimen, drug exposures achieved with the oral dose were 81% of those achieved with IV dosing, approximately double the exposure observed with the dosing regimen used in IGNITE2."

Dr. Horn continued, "We have also seen promising data in phase 1 clinical trials using a new oral eravacycline formulation and we will continue phase 1 development of this new formulation in parallel, as it could represent a future life-cycle option for oral eravacycline."
...

http://ir.tphase.com/releasedetail.cfm?ReleaseID=1042742

[DasTier666]

Novasep unterzeichnet Herstellungsvereinbarung mit dem biopharmazeutischen Unternehmen Tetraphase für den Wirkstoff Eravacyclin
LYON, Frankreich, December 12, 2017 /PRNewswire/

https://www.prnewswire.com/de/pressemitteilungen/novasep-unt…

[DasTier666]

Tetraphase Pharmaceuticals Announces Submission of New Drug Application to FDA for Eravacycline for the Treatment of Complicated Intra-Abdominal Infections (cIAI)
Jan 2, 2018

Submission Supported by Positive Data from IGNITE1 and IGNITE4 Clinical Trials
WATERTOWN, Mass., Jan. 02, 2018 (GLOBE NEWSWIRE) -- Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a clinical stage biopharmaceutical company developing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, today announced that it has submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for intravenous (IV) eravacycline for the treatment of complicated intra-abdominal infections (cIAI).
The NDA submission includes data from the IGNITE1 and IGNITE 4 phase 3 clinical trials, in which twice-daily IV eravacycline was well tolerated and achieved high clinical cure rates in patients with cIAI. Both studies demonstrated statistical non-inferiority of eravacycline to two widely used comparators – ertapenem in IGNITE1 and meropenem in IGNITE4 – for the primary efficacy endpoint of clinical response at the test-of-cure (TOC) visit.
“The submission of the NDA filing for IV eravacycline, supported by positive data from two pivotal trials investigating the drug for the treatment of cIAI, is a critical milestone for Tetraphase,” said Guy Macdonald, President and CEO of Tetraphase. “We believe that eravacycline has the potential to play a key role in the treatment of serious hospital infections, particularly Gram-negative infections. We are now one step closer to realizing the goal of bringing this medicine to the market."

http://ir.tphase.com/news-releases/news-release-details/tetr…

Na das könnte ja ein gutes Jahr für Tetraphase werden.

[bcgk]

Antwort auf Beitrag Nr.: 56.600.540 von DasTier666 am 03.01.18 15:07:38

https://fintel.io/doc/www.sec.gov/Archives/edgar/data/137370…

BlackRock hat kräftig aufgestockt und besitzt nun knapp 8% an TTPH. Klares Kaufsignal mMn.

[DasTier666]

Antwort auf Beitrag Nr.: 56.912.018 von bcgk am 02.02.18 13:30:55

Sehe ich auch so. Ich hatte selber erst nochmal nachgelegt, aber leider bei 5,-€. Sollte hier eine positive Entscheidung fallen, dürfte es schnell nach oben gehen.

[bcgk]

Antwort auf Beitrag Nr.: 56.927.840 von DasTier666 am 04.02.18 18:44:42

Bei TTPH ist es mMn beinahe egal, ob man 4,5€, 5€ oder 6€ bezahlt hat. Entweder die bekommen die Zulassung und damit die Kurve, dann sehen wir Kurse deutlich oberhalb von 10$. Wenn die Zulassung nicht erteilt wird, kann man die Bude wohl zumachen. Ist also High Risk, allerdings denke ich, dass BlackRock nicht ohne Plan mal eben 8% an TTPH erwirbt.

[bcgk]

Antwort auf Beitrag Nr.: 56.927.840 von DasTier666 am 04.02.18 18:44:42

Nachbörslich 60% im Minus bei noch 2.15$.

Eravacycline Did Not Achieve Co-Primary Endpoints in cUTI Trial ̶

̶ Company Continues to Prepare for Commercialization of Eravacycline as a Treatment for cIAI in the U.S. and Europe, Assuming Regulatory Approval ̶

̶ Conference Call Scheduled for Today at 4:30 p.m. ET ̶

WATERTOWN, Mass., Feb. 13, 2018 (GLOBE NEWSWIRE) -- Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a biopharmaceutical company focused on developing and commercializing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, today announced that its IGNITE3 clinical trial evaluating the efficacy and safety of once-daily intravenous (IV) eravacycline compared to ertapenem for the treatment of patients with complicated urinary tract infections (cUTI) did not achieve statistical non-inferiority of eravacycline to ertapenem. The study failed to meet the co-primary efficacy endpoints of responder rate (a combination of clinical cure and microbiological success) in the microbiological intent-to-treat (micro-ITT) population at the end-of-IV (EOI) treatment visit and at the test-of-cure (TOC) visit, which were evaluated using a 10% non-inferiority margin. Eravacycline was well tolerated in IGNITE3, with a safety profile consistent with prior studies.

“We are surprised and obviously very disappointed that the IGNITE3 trial did not achieve its co-primary endpoints and are fully analyzing the data to understand this outcome,” said Guy Macdonald, President and CEO of Tetraphase. “Independent of this outcome, we continue to move forward with our registration strategy for eravacycline in complicated intra-abdominal infections (cIAI). We currently have an NDA under review with the FDA as well as an MAA under review by the EMA in Europe, which are based on the positive outcomes demonstrating high cure rates and favorable tolerability in the IGNITE1 and IGNITE4 phase 3 clinical trials of IV eravacycline in cIAI. We are actively preparing for the commercialization of eravacycline as a treatment in cIAI in both the U.S and in Europe, assuming regulatory approvals.”

[DasTier666]

Antwort auf Beitrag Nr.: 57.018.402 von bcgk am 13.02.18 22:46:48

Das ist bitter, nun bleibt nur das warten auf den Entscheid der FDA und EMA über Eravacycline in cIAI.

[paul81]

perfektes Timing bin vor zwei Tagen (mit einer kleinen Position) eingestiegen... nachbörslich wird die Aktie auf Cashniveau gehandelt

[paul81]

evtl. ein guter Einstiegspunkt für risikotolerante Investoren
https://seekingalpha.com/article/4146351-tetraphase-failures…

[bcgk]

Antwort auf Beitrag Nr.: 57.019.227 von paul81 am 14.02.18 07:34:03

Buchwert 2,92$ pro Aktie
Cash 1,61$ pro Aktie.

Auf derzeitigen Niveau von 2,18$ aussichtsreich für Zocker. Hab mir 1k zu 2,12$ gegönnt. Mal sehen...allerdings wenn die 2 fällt, dürften unendliche SL bei 1,95-1,99 lauern. Daher nochmal zweite Order bei 1,8$ aufgestellt.

[Cyberhexe]

Antwort auf Beitrag Nr.: 57.025.998 von bcgk am 14.02.18 18:23:11

IGNITE3 - enttäuschendes Ergebnis.

Bleibt die eingereichte Zulassung bei Infektionen des Bauchraumes:


WATERTOWN, Mass., Jan. 02, 2018 (GLOBE NEWSWIRE) -- Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a clinical stage biopharmaceutical company developing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, today announced that it has submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for intravenous (IV) eravacycline for the treatment of complicated intra-abdominal infections (cIAI).


Kurserholung möglich, falls NDA von der FDA akzeptiert wird - Entscheidung bis Anfang März.
Rechne eigentlich mit einer formellen Annahme des Antrages und habe deshalb meine "rote Position" heute verdoppelt....allerdings nicht mit Langzeitperspektive!

[DasTier666]

Tetraphase Pharmaceuticals Enters into Exclusive Development and Commercialization Agreement with Everest Medicines for Eravacycline in China
WATERTOWN, Mass., Feb. 20, 2018 (GLOBE NEWSWIRE)

Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a biopharmaceutical company focused on developing and commercializing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, today announced that it has entered into an exclusive licensing agreement with Everest Medicines Limited (“Everest”), a C-Bridge Capital-backed biopharmaceutical company based in China, to develop and commercialize eravacycline in mainland China, Taiwan, Hong Kong, Macau, South Korea, and Singapore (the “Territories”).
Under the terms of the agreement, Tetraphase will receive an initial upfront payment of $7.0 million and may receive clinical and regulatory milestones of up to $16.5 million as well as annual sales milestones of up to $20.0 million. Everest will be solely responsible for the development and commercialization of eravacycline in the Territories. Tetraphase and Everest will establish a joint steering committee to review and oversee all of Everest’s development and commercialization plans. Tetraphase will also be eligible to receive double digit tiered royalties on net sales of eravacycline in the Territories.
“Our agreement with Everest marks an important step in our plans to bring eravacycline to market on a global level,” said Guy Macdonald, President and Chief Executive Officer of Tetraphase. “With positive Phase 3 data evaluating IV eravacycline in cIAI, our NDA under review by the FDA in the U.S. and our Marketing Authorization Application also under review in Europe, both for cIAI, we are expanding our commercialization strategy to China and other Asian territories and countries. With new regulations in place in China to accelerate development and approval, along with high levels of multidrug-resistant infections there, we believe there is a significant opportunity for eravacycline to become an important new treatment in China and other territories. We are excited to have Everest as a partner and expect their development and commercialization expertise, as well as strategy for leveraging changes in the regulatory environment, will be invaluable in maximizing the value of eravacycline in the Chinese market. We look forward to working with Everest to bring eravacycline to patients and addressing a critical unmet need in a region where viable treatment options are scarce.”

http://ir.tphase.com/node/9841

[bernie55]

Antwort auf Beitrag Nr.: 57.027.342 von Cyberhexe am 14.02.18 20:27:10

Zitat von Cyberhexe: Kurserholung möglich, falls NDA von der FDA akzeptiert wird - Entscheidung bis Anfang März.

Rechne eigentlich mit einer formellen Annahme des Antrages und habe deshalb meine "rote Position" heute verdoppelt....allerdings nicht mit Langzeitperspektive!

Tetraphase Pharmaceuticals Announces FDA Acceptance for Filing of its NDA Submission for Eravacycline for the Treatment of Complicated Intra-Abdominal Infections (cIAI)

GlobeNewswire•February 27, 2018

WATERTOWN, Mass., Feb. 27, 2018 (GLOBE NEWSWIRE) -- Tetraphase Pharmaceuticals, Inc. (TTPH), a biopharmaceutical company focused on developing and commercializing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, today announced that it has received notification from the U.S. Food and Drug Administration (FDA) that the FDA has completed its initial 60-day review of the New Drug Application (NDA) for eravacycline for the treatment of complicated intra-abdominal infections (cIAI), and determined that the application is sufficiently complete to permit a substantive review. The PDUFA (Prescription Drug User Fee Act) goal date for the completion of the FDA’s review of the eravacycline NDA is set for August 28, 2018.

This date reflects a priority 6-month review period.

“The FDA’s acceptance for review of our NDA submission for IV eravacycline in cIAI marks an important step in our goal to bring this important new treatment option to patients in need,” said Guy Macdonald, President and CEO of Tetraphase. “We believe that eravacycline has the potential to play a key role in the treatment of serious intra-abdominal infections, particularly Gram-negative infections, and we look forward to providing an update on a regulatory decision in August as we continue to prepare for a commercial launch."

The NDA submission includes data from the IGNITE1 and IGNITE 4 phase 3 clinical trials, in which twice-daily IV eravacycline was well tolerated and achieved high clinical cure rates in patients with cIAI. Both studies demonstrated statistical non-inferiority of eravacycline to two widely used comparators – ertapenem in IGNITE1 and meropenem in IGNITE4 – for the primary efficacy endpoint of clinical response at the test-of-cure (TOC) visit.


https://finance.yahoo.com/news/tetraphase-pharmaceuticals-an…" target="_blank" rel="nofollow ugc noopener">
https://finance.yahoo.com/news/tetraphase-pharmaceuticals-an…

[bernie55]

Antwort auf Beitrag Nr.: 57.133.332 von bernie55 am 27.02.18 15:11:22

B.Riley FBR Thinks Tetraphase’s Stock is Going to Recover
By Austin Angelo

Tetraphase (NASDAQ: TTPH) In a report released today, Madhu Kumar from B.Riley FBR reiterated a Buy rating on Tetraphase (NASDAQ: TTPH), with a price target of $6. The company’s shares closed yesterday at $2.87, close to its 52-week low of $2.05.

http://www.analystratings.com/articles/b-riley-fbr-thinks-te…

[Cyberhexe]

Antwort auf Beitrag Nr.: 57.027.342 von Cyberhexe am 14.02.18 20:27:10

Zitat von Cyberhexe: IGNITE3 - enttäuschendes Ergebnis.

Bleibt die eingereichte Zulassung bei Infektionen des Bauchraumes:


WATERTOWN, Mass., Jan. 02, 2018 (GLOBE NEWSWIRE) -- Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a clinical stage biopharmaceutical company developing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, today announced that it has submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for intravenous (IV) eravacycline for the treatment of complicated intra-abdominal infections (cIAI).


Kurserholung möglich, falls NDA von der FDA akzeptiert wird - Entscheidung bis Anfang März.
Rechne eigentlich mit einer formellen Annahme des Antrages und habe deshalb meine "rote Position" heute verdoppelt....allerdings nicht mit Langzeitperspektive!

Spätestens Ende August wird die FDA über die Zulassung bei cIAI entscheiden:

“During the first quarter, we revised our eravacycline strategy to focus primarily on the commercialization of the IV formulation of the drug in complicated intra-abdominal infections (cIAI), for which we have submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) based on the positive results of the IGNITE1 and IGNITE4 phase 3 clinical trials,” said Guy Macdonald, President and Chief Executive Officer of Tetraphase. “We recently presented data from IGNITE4, in which eravacycline demonstrated statistical non-inferiority to meropenem, at the 28th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID). We believe these data underscore the opportunity for eravacycline to address a critical unmet need in the treatment paradigm for gram-negative, multidrug-resistant infections. We are especially excited to move forward with commercial preparations to bring eravacycline to market as a treatment for cIAI in the second half of 2018, pending U.S. regulatory approval following our PDUFA date of August 28.”

[Cyberhexe]

Antwort auf Beitrag Nr.: 57.744.778 von Cyberhexe am 12.05.18 08:38:43

U.S. FDA approves Tetraphase Pharma's antibiotic
Reuters Reuters•August 27, 2018

https://ir.tphase.com/node/10121