Once again, it was a rough week for the biotech sector with the NASDAQ Biotechnology Index declining 3.37% over the last five trading days. While companies like GW Pharma (GWPH - Free Report) shot up on positive pipeline data, Orexigen announced a couple of deals related to its obesity drug, Contrave.
Recap of the Week’s Most Important Stories
1. GW Pharma’s shares were up a whopping 120.2% on news that the company’s lead cannabinoid pipeline candidate, Epidiolex, scored in a late-stage study. The study was conducted in patients with Dravet syndrome, a rare and debilitating type of epilepsy for which no treatments are currently approved in the U.S. The next step in the company’s development plan is to set up a pre-NDA meeting with the FDA to discuss a potential regulatory application (Read More: GW Pharmaceuticals Skyrockets on Favorable Epilepsy Data).
2. Orexigen, known for its branded obesity treatment, Contrave, announced that it will be terminating its collaboration agreement with Takeda for the drug. The termination of this deal will result in Orexigen acquiring U.S. rights to the drug. Orexigen also said that it is partnering with Valeant for the commercialization of Contrave (EU trade name: Mysimba) in 18 Central and Eastern European countries and Turkey. Valeant intends to start selling Mysimba in the second half of the year.
3. Is Gilead’s (GILD - Free Report) blood cancer drug, Zydelig, in trouble? Problems for the drug have cropped up with regulatory authorities in both the U.S. and the EU looking into safety concerns (a higher rate of serious adverse events including deaths, mostly due to infections, have been observed in studies being conducted in combination with other cancer medicines) associated with the drug (Read More: Gilead's Zydelig under EU Review amid Safety Concerns).
The FDA has also issued alerts to healthcare professionals about the higher rate of adverse events. Moreover, Gilead said that it is halting 6 ongoing studies in patients with chronic lymphocytic leukemia, small lymphocytic lymphoma and indolent non-Hodgkin lymphomas. Negative findings could well put a stop to Gilead’s plans to expand the drug’s label for use in combination with other treatments.
4. Regeneron (REGN - Free Report) and partner Sanofi came out with positive head-to-head data on their experimental rheumatoid arthritis treatment, sarilumab, compared to AbbVie’s (ABBV - Free Report) Humira. Sarilumab, which could well be Regeneron’s next blockbuster, is currently under FDA review with a response expected later this year (Read More: Regeneron/Sanofi Report Positive Sarilumab Phase III Data).
5. Sarepta’s (SRPT - Free Report) shares are up with the FDA announcing that an advisory panel will meet on Apr 25 to review the company’s experimental Duchenne muscular dystrophy (DMD) treatment, eteplirsen. The FDA had previously cancelled an advisory panel meeting earlier this year due to bad weather. Briefing documents issued at that time were not favorable with the agency raising concerns about the drug’s efficacy.
We remind investors that experimental DMD treatments have not exactly fared well on the regulatory front -- while BioMarin got a complete response letter from the FDA for Kyndrisa in January, the agency issued a “refusal to file” letter for PTC Therapeutics' experimental DMD treatment, Translarna in February.
Most major biotech stocks lost ground last week with Regeneron declining 6.99% while Gilead gained 0.88%. Meanwhile, Vertex (VRTX - Free Report) lost 38.85% over the last six months (See the last biotech stock roundup here: AbbVie's Imbruvica Label Expanded, Celldex Slumps on Study Update).
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What's Next in the Biotech World?
Watch out for the usual pipeline updates and data presentations from biotech companies.
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