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CEMP. I followed the adcomm discussions all day. Very enlightening. I guess FDA will approve Soli if CEMP commit to a phase IV pharmacovigilance study. And Gono next year should be good.
And next 4th of November, adcomm meeting. CEMP
totally agree. EOM
GILD: Gilead Sciences has added a news release to its Investor Relations website.
Title: Gilead Announces SVR12 Rates From Four Phase 3 Studies of a Once-Daily, Fixed-Dose Combination of Sofosbuvir, Velpatasvir and Voxilaprevir in Treatment-Naïve and Treatment-Experienced Genotype 1-6 Chronic HCV-Infected Patients
Date(s): 20-Oct-2016 10:07 AM
For a complete listing of our news releases, please click here
- If Approved, SOF/VEL/VOX Would Be the First Once-Daily Single Tablet Regimen Available for Salvage for Patients Who Have Failed Prior HCV Therapy with Oral Direct-Acting Antiviral Agent Regimens -
- U.S. NDA Planned for Q4 2016 -
FOSTER CITY, Calif.--(BUSINESS WIRE)--Oct. 20, 2016-- Gilead Sciences, Inc. (NASDAQ: GILD) today announced topline results from four international Phase 3 clinical studies (POLARIS-1, POLARIS-2, POLARIS-3 and POLARIS-4) evaluating an investigational, once-daily, fixed-dose combination of sofosbuvir (SOF), a nucleotide analog NS5B polymerase inhibitor; velpatasvir (VEL), a pangenotypic NS5A inhibitor; and voxilaprevir (VOX; GS-9857), an investigational pangenotypic NS3/4A protease inhibitor, for the treatment of genotype 1-6 chronic hepatitis C virus (HCV) infection.
In the POLARIS-1 and POLARIS-4 studies, 445 patients with genotype 1-6 HCV infection who were previously treated with direct-acting antiviral agents (DAAs) received 12 weeks of SOF/VEL/VOX. The POLARIS-1 study enrolled patients who failed prior treatment with an NS5A inhibitor. The POLARIS-4 study enrolled patients who failed prior treatment with a DAA that was not an NS5A inhibitor, most with either an NS5B inhibitor alone (73 percent) or an NS5B inhibitor and an NS3/4A protease inhibitor (25 percent).
In the POLARIS-2 and POLARIS-3 studies, 611 patients who were not previously treated with a DAA received 8 weeks of SOF/VEL/VOX. The POLARIS-2 study enrolled patients with genotype 1-6 HCV infection with or without compensated cirrhosis. The POLARIS-3 study enrolled patients with genotype 3 HCV infection, all of whom had compensated cirrhosis.
The primary endpoint for all studies was SVR12. The intent-to-treat SVR12 rates observed in the POLARIS studies are summarized in the following table. Complete results from all four studies will be presented at The Liver Meeting® 2016 in Boston.
Study Population Genotype Treatment Duration SVR12 Rates
POLARIS-1 NS5A inhibitor-experienced
41 percent (172/415) had cirrhosis
1, 2, 3, 4, 5, 6 SOF/VEL/VOX 12 Weeks 96%
(253/263)
Placebo 12 Weeks 0%
(0/152)
POLARIS-4
DAA-experienced (No NS5A inhibitor)
46 percent (153/333) had cirrhosis
1, 2, 3, 4 SOF/VEL/VOX 12 Weeks 97%
(177/182)
SOF/VEL 12 Weeks 90%
(136/151)
POLARIS-2 DAA-naïve
18 percent (174/941) had cirrhosis
1, 2, 3, 4, 5, 6 SOF/VEL/VOX 8 Weeks 95%
(476/501)
SOF/VEL 12 Weeks 98%
(432/440)
POLARIS-3 DAA-naïve
All had cirrhosis
3 SOF/VEL/VOX 8 Weeks 96%
(106/110)
SOF/VEL 12 Weeks 96%
(105/109)
Patients treated with SOF/VEL/VOX for 12 or eight weeks had similar overall incidence of adverse events compared to placebo-treated or SOF/VEL-treated patients. The most common adverse events among patients who received SOF/VEL/VOX were headache, fatigue, diarrhea and nausea. Among the 1,056 patients who received SOF/VEL/VOX in the four studies, one patient (less than one percent) receiving SOF/VEL/VOX for 12 weeks discontinued due to an adverse event.
"Despite recent advances that have provided high cure rates and simplified treatment for most HCV patients, those who have failed previous treatment with direct acting antivirals continue to represent an unmet medical need. The POLARIS study results demonstrate that combining three potent antivirals with different mechanisms of action and high barriers to resistance can provide high cure rates for patients who have failed other highly effective oral DAA regimens," said Norbert Bischofberger, Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer at Gilead. "Based on these Phase 3 results, we plan to submit regulatory applications for SOF/VEL/VOX for the treatment of chronic HCV in the United States in the fourth quarter of 2016 and shortly thereafter in Europe."
About the POLARIS Studies
The POLARIS-1 study was a double-blind, placebo-controlled study in 415 genotype 1-6 NS5A inhibitor-experienced patients. The most common prior NS5A inhibitors were ledipasvir (55 percent) and daclatasvir (23 percent).
The open-label POLARIS-4 study evaluated the use of SOF/VEL/VOX or SOF/VEL for 12 weeks in 333 genotype 1-4 HCV-infected patients with prior DAA experience that did not include an NS5A inhibitor. Most patients (85 percent) had prior DAA experience with sofosbuvir.
The open-label POLARIS-2 study evaluated the use of SOF/VEL/VOX for eight weeks or SOF/VEL for 12 weeks in 941 genotype 1-6 DAA-naïve HCV-infected patients, including 18 percent with cirrhosis and 23 percent who had previously failed treatment with an interferon-based regimen.
The open-label POLARIS-3 study randomized patients with genotype 3 HCV infection and cirrhosis to receive SOF/VEL/VOX daily for eight weeks or SOF/VEL for 12 weeks. Of the 219 patients treated, 31 percent had previously failed treatment with an interferon-based regimen.
The POLARIS-1, POLARIS-3 and POLARIS-4 studies met their respective pre-specified primary endpoints for the patients receiving SOF/VEL/VOX. The POLARIS-2 study did not meet its primary endpoint; with a pre-specified 5 percent margin, the SVR12 rate for patients receiving treatment with SOF/VEL/VOX for eight weeks was not statistically non-inferior to the SVR12 rate for patients receiving SOF/VEL for 12 weeks.
About SOF/VEL/VOX
The SOF/VEL/VOX fixed-dose combination is an investigational product and its safety and efficacy have not been established. It has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration for the treatment of chronic genotype 1 HCV patients who have previously failed an NS5A inhibitor-containing regimen.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.
Forward-Looking Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that future trials involving the SOF/VEL/VOX fixed-dose combination may have unfavorable results. In addition, Gilead may be unable to file for U.S. regulatory approval of the SOF/VEL/VOX fixed-dose combination in the United States and Europe in the currently anticipated timelines. In addition, the FDA and other regulatory agencies may not approve the SOF/VEL/VOX fixed-dose combination, and any marketing approvals, if granted, may have significant limitations on its use. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended June 30, 2016, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
For more information on Gilead Sciences, please visit the company's website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
View source version on businesswire.com: http://www.businesswire.com/news/home/20161020005942/en/
Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.
Investors
Sung Lee, 650-524-7792
Media
Mark Snyder, 650-522-6167
IN none. They are pumping the stock in order to be able to raise more cash as they need it soon
TGTX. Nothing to worry about and they save $10M
TG Therapeutics, Inc. Amends the GENUINE Phase 3 Clinical Trial to Accelerate Study Completion by Revising Primary Endpoint to Overall Response Rate
FDA agrees that Overall Response Rate (ORR) data from revised GENUINE study can be used to request pre-BLA (Biologics License Application) meeting
If results of the revised GENUINE study are positive, the Company plans to file a BLA for accelerated approval based on the outcome of the pre-BLA meeting
Enrollment expected to be completed before year end 2016 with top-line data available in first half of 2017
Amendments expected to save the Company more than $10 million over the next 2 years, and allow the Company to focus its resources on the UNITY-CLL program
http://ir.tgtherapeutics.com/releaseDetail.cfm?ReleaseID=993364
Master, good call on ALNY. I lost track of them many years ago, when they were founded and had their first patent disputes with Ribopharma AG. At that time , they were a promising company leading de development of a new class of drugs, the beginnings of RNAi in the clinic...I lost interest when I saw the company was hyped and with an unjustifiable market cap.
If what you say is true, they shouldn't ever even started the phase 3, for ethical reasons.
what do you think of Patisiran? would be affected at all by this setback? do you think is also a bad drug?
what about other TTR approach (much more early stage) like NTLA?
thanks.
I al long ARDM. they have a Deal with Grifols
CEMP: yes, that is why it is not silly at all. The stock plunged 8% on a bad IBB day, so why not put a PR about the hot NASH story, to recover the price drop!
ABUS: Agree, data very early. But not sure about their aim to raise capital very soon, bear in mind they raised when the stock was at around $20 (when they were TKMR) and today is trading at $3s.
The team working on these are the ex-Pharmasset team, ones who developed Sovaldi. I think it is too early to tell but lets see if they do it again.
AMGN RDUS
I guess/hope AMGN news could favour again RDUS, specially after Merck pulled out Odanacatib
ARRY, Actually +60%. Sold 2/3 today after the news
ACHN News. Halted trading and opened +7% but all known
http://globenewswire.com/news-release/2016/09/23/874228/0/en/Achillion-Announces-100-SVR12-in-the-6-Week-and-8-Week-Cohorts-in-Janssen-s-Phase-2-Trial-Evaluating-the-Triple-Combination-Treatment-Regimen-Including-Odalasvir-AL-335-and-Simepre.html?f=22&fvtc=9&fvtv=United%20States
No surprise at all! EOM
Thank you. EOM
Dew, I asked you about TBRA a month ago. You were not positive about it but after some DD decided to buy. Didn't expect the huge premium though ...
Allergan takes out Tobira for $28.35 and up to $49.84 in CVRs
http://www.seekingalpha.com/news/3209752
NVAX: Thanks for your reply.
There is also the possibility that it is not a lower infection rate season but that if most patients were recounted from same areas or neighbourhoods, the people with the vaccine prevented the others to get infected.
Apparently many of the Resolve trial participants come from community living centers. How do you explain a mere 1'8% attack rate in the phase 3 placebo group?
NVAX. Apparently phase fail was total failure. Company is holding investor meeting 11 October where they will discuss in more detail after having analysed the data in detail. The R&D chief said RSV infection rate was lower than normal in this season so that could be a cause, but it is difficult to think bad outcome is due to a bad clinical design or other external factors. Anyone had a look at the data or comment here if thinks vaccine just does not work?
Big Pharma are developing vaccines for RSV vaccine too, now that the RSV structure is known, with a different approach, but at this point only NVAx, which was ahead in trials, has sown effectively in phase II. Phase II and Phase III data does not match at all.
Yes, same reason BLUE is Up 8% today both SGYP for GI and BLUE in onco have been mentioned by Analysts today as potential Takeda takeout targets... We will see
BTW, Do you know why it went from $10 to $0.5 share price in two years?
If the article is correct, Perella Weinberg Partners is acting as advisor to sale the company. maybe they have started the rumor.
An article at intereconomia also states the buyer was Concordia International ??? but new bidders have emerged before closing the deal. That company ONLY has $330M mkt cap, I very much doubt they would buy PTX for $800M...
All this info is quite odd. I would not pay much attention to it.
Strange these articles are posted at Intereconomia site. To my knowledge intereconomia is a Spanish channel focused mainly on politics. Supporting the right party BTW. Don even know why they write about USA small biotech to be honest. Does not seem to be the interest of Intereconomia´s readers.
OK, so Intereconomia was wrong and gave a false news stating Raptor will be bought out by Shire. It didn't.
Why would we think it is a trustable source and they will be right this time?
This news should favour RDUS, which is doing quite well not being affected despite IBB pressure these days
I posted here when NTLA went for IPO, that I was interested in the company as a long term investment but I never bought because of the patent dispute AND the high valuation for such an early stage company. Price has come down below IPO and well below highest price of $30. but for such a risky investment I would consider to buy only below $10.
What are your thoughts on NTLA? Would be the best pick among the CRISPR universe? Do you have good opinion on Doudna? I like the CEO and also the VCs behind the investment are trustable and I guess they did a good DD in terms of IP before backing the company.
I Also think it shouldn't be allowed to close the way to future CRISPR research with excessive granting patents, in a technology with so many possibilities.
CRISPR tech: here an interesting article on the IP situation from a lawyer perspective:
http://www.biochemist.org/bio/03803/0026/038030026.pdf
MOst of the posters here have shares in ENTA or GILD. Haven't read any comment on ACHN investors here recently. I believe the Jansen/ACHN deal will deliver.
Many could be next...also RDUS, NVAX, SGYP...
AND dropping in pre market like a rock
NVAX great day to add today after earnings miss. We are so close to RSV data readout
Thanks EOM
TBRA; Dew, I believe you have been following NASH because you invested in CNAT in the past., are you familiar with TBRA? I would like to get some opinion on this one, as it is near 52WL and they are going to release data for phase 2 NASH trial (Cenicriviroc, a dual CCR2 and CCR5 antagonist for treating patients with NASH). I am doing some DD on it and looks interesting IMO. Thanks in advance
NVAX. Thanks to all for the feedback. I see all are positive. I am also long the stock. My average is low $6s. As one of the posters said I might sell some before data release but I am also cautiously optimistic and feel comfortable owning shares into the readout. Although many expect data in early September, it could be any day now, note the RSV symposium is on the 27th of August and NVAX is sponsor, it would make Sense that data is already out before that event to make the most of it. Good luck!
NVAX For some reason I have not seen much discussion on this company here. Anybody following or invested? I would like to hear your opinions. They are about to release Phase 3 data for RSV vaccine so the company is at its most important time.
ARRY. The rise is probably because shorts are closing positions.
P3 data for selumetinib in kras+ NSCLC due anytime now
BIIB: I believe Scangos exit is positive for the company and the street also sees this as positive news. New leadership is needed IMO. Stelios could leave the board as well in the future.
ZIOP. Despite the positive news today, And the positive movement premarket, ZIOP is down -10% today. Also XON. Any explanation for this action today?
ZIOP: Death unrelated to treatment. Shares up premarket
• In a statement, ZIOPHARM (NASDAQ:ZIOP) says the recent patient death from intracranial hemorrhage in its Phase 1 clinical trial assessing Ad-RTS-hIL-12 + orally administered veledimex in progressive glioblastoma or grade III malignant glioma was determined to be unrelated to the study drug.
• Enrollment remains open. The company will provide further updates when appropriate. Longer-term survival data will be released later this year.
• Shares are up 9% premarket on increased volume.
JUNO. Well, that was fast. I had buy orders for both JUNO and KITE but didn't get filled. They were a bit lower to yesterday´s close. I was expecting a quick FDA response and lift but not that quick! Congrats to those who added after the news of trial stopped. I keep my JUNO IPO shares for the moment though.