The Food and Drug Administration has requested more data on Clovis’ lead drug candidate rociletinib as it reviews the company’s new drug application, which will likely delay the drug’s approval, currently slated for March 30 of next year. More importantly, the updated results requested by FDA and released on Monday morning call into question rociletinib’s commercial potential, as the FDA just last week approved a similar, competing drug. Worse still, Clovis acknowledged that the latest news may jeopardize the drug’s Breakthrough Therapy Designation, received in May of 2014, which expedites the drug’s review and has been a point of confidence for Clovis’ investors.
Wall Street has taken CLVS to the chopping block, trimming the stock by 70% on Monday as the drug’s commercial potential and approval status both come into question.
Bad news aside, the final rub lies in Clovis’ acknowledgment during a conference call Monday that thecompany has had these updated results – suggesting that rociletinib may be inferior since the end of October.
Clovis price target cut to $28 from $92 at Piper Jaffray
Piper Jaffray analyst Charles Duncan cut his price target for shares of Clovis Oncology (CLVS) to $28 from$92 after the company announced that rociletinib efficacy data matured and the number of patients with a confirmed response is lower than expected.
November 17, 2015
AstraZeneca gains from rival’s trial setback
Bryce Elder Bryce Elder
Clovis Oncology of the US said the number of patients confirmed to be responding to its experimental treatment for lung cancer, rociletinib, was much lower than previously indicated. Its drug has been seen as the main rival of Tagrisso, AstraZeneca’s potential blockbuster, which on Friday unexpectedly won early approval from the US regulator. “Rociletinib now looks likely to be delayed and has a materially inferiorprofileto Tagrisso,” said Deutsche Bank. Deutsche had been forecasting Tagrisso sales of $1bn which it said now looked conservative. Dependent on more trials, the sales opportunity could be as big as $2.5bn to$3bn
Way too cheap here, All in baby.
Sentiment: Strong Buy
Anavex Announces Preparation of Regulatory Filings Based on Guidance From the FDA
Anavex Life Sciences Corp.
3 hours ago
NEW YORK, Nov. 18, 2015 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (AVXL), a clinical-stage biopharmaceutical company developing drug candidates to treat Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer, announces that it is moving forward with the development program for ANAVEX 2-73. Guidance received from the FDA confirms the Company’s strategy to advance ANAVEX 2-73 for the treatment of Alzheimer’s disease in a larger double-blinded, randomized, placebo-controlled Phase 2/3 trial.
Adam F what a fool !
wow do the DD