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 shot up on positive pipeline data, Orexigen OREX announced a couple of deals related to its obesity drug, Contrave.
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.
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. Is Gilead’s GILD 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 associated with the drug. The FDA has also issued alerts to healthcare professionals about the higher rate of adverse events.
Negative findings could well put a stop to Gilead’s plans to expand the drug’s label for use in combination with other treatments.
Sarilumab, which could well be Regeneron’s next blockbuster, is currently under FDA review with a response expected later this year.
Sarepta’s SRPT 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 treatment, eteplirsen.
The FDA had previously canceled 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.
Performance Most major biotech stocks lost ground last week with Regeneron declining 6.99% while Gilead gained 0.88%. Meanwhile, Vertex VRTX lost 38.85% over the last six months.