With earnings season winding down, regulatory and pipeline updates from the biotech sector are back in focus. Clovis Oncology's CLVS shares plunged 70% as the company is possibly facing a delay in gaining FDA approval for its lead pipeline candidate. Meanwhile, companies like Gilead GILD and AbbVie ABBV provided pipeline and regulatory updates.
Recap of the Week's Most Important Stories
1. Clovis, which is focused on bringing cancer treatments to market, suffered a huge setback with the FDA asking the company to submit additional data on its lead pipeline candidate, rociletinib. Clovis is seeking both FDA and EMA approval for rociletinib for a non-small cell lung cancer indication.
The FDA was supposed to decide on the approval status of the candidate by Mar 30, 2016, but now that the agency is asking for additional information, there is low visibility as to when a response will be out (Read more: Clovis Crashes 70%, FDA Seeks More Data on Rociletinib ).
2. The Medicines Company MDCO got some good news with its petition for en banc review being granted. The company had filed the petition related to the decision of the U.S. Court of Appeals for the Federal Circuit invalidating the Orange Book patents covering Angiomax.
3. It's been a busy week for Gilead - the FDA approved the company's blockbuster hepatitis C virus (HCV) treatment, Harvoni for use in additional patient populations (Read more: Gilead's HCV Drug Harvoni's Label Expanded in U.S. ). Moreover, the company said that its late-stage study evaluating Zydelig plus standard therapy in previously-treated chronic lymphocytic leukemia patients will be unblinded early on the recommendation of an independent Data Monitoring Committee (Read more: Gilead's Leukemia Study Unblinded Early on Positive Data) .
4. AbbVie presented data on its investigational HCV regimen, ABT-493 (an NS3/4A protease inhibitor) and ABT-530 (an NS5A inhibitor) from a couple of mid-stage studies at the annual meeting of the American Association for the Study of Liver Diseases (AASLD). The company also presented new data on its approved HCV treatment, Viekira Pak, from an ongoing late-stage study.
Meanwhile, AbbVie continues to progress with its efforts to expand Imbruvica's label. The company has submitted Imbruvica phase III combination data to the FDA (Read more: AbbVie Reports Encouraging Data on HCV Drug Viekira Pak ).
Performance
Vertex VRTX was the highest gainer (7.87%) among major biotech stocks over the last five trading days with Biogen BIIB declining 4.61% during this period. Meanwhile, Biogen lost 27.53% over the last six months with Regeneron being the highest gainer (16.75%) during this period.
The NASDAQ Biotechnology Index declined 0.83% over the last five trading days (See the last biotech stock roundup here: AbbVie's Humira Remains Strong, Shire to Buy Dyax ).
What's Next in the Biotech World?
BioMarin BMRN has an important regulatory event coming up with the FDA's advisory panel scheduled to review the company's experimental treatment for Duchenne muscular dystrophy treatment, Kyndrisa, next week.
Meanwhile, quite a few companies will present abstracts at the American Heart Association (AHA) Scientific Sessions 2015.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
