It was a pretty eventful week in the biotech sector - KaloBios KBIO grabbed headlines with the company getting funds from a Martin Shkreli led group. Meanwhile, BioMarin's BMRN experimental Duchenne muscular dystrophy (DMD) treatment, Kyndrisa, came up for review before an FDA advisory panel. Other companies like Amgen AMGN and Vertex VRTX provided regulatory/pipeline updates.
Recap of the Week's Most Important Stories
1. An FDA advisory panel met to discuss BioMarin's experimental DMD treatment, Kyndrisa. The panel reviewed the Kyndrisa data package and was asked to discuss the overall strengths and weaknesses of the application but was not asked to vote on a recommendation for approval of Kyndrisa. Most of the questions related to efficacy got negative or neutral votes with just one vote in favor of a question related to Study 1. With the panel not finding the data convincing enough to support efficacy, chances are that BioMarin may not gain FDA approval by Dec 27. Meanwhile, Sarepta, which is looking to get its experimental DMD treatment approved, has an advisory panel meeting coming up in January.
2. KaloBios' shares soared more than 400% as the company, which was preparing to wind down operations, found a savior in the form of Martin Shkreli. An investor group led by Shkreli acquired 70% of KaloBios' shares. Shkreli is now the Chief Executive Officer of the company (read more: KaloBios Soars on Investment by Martin Shkreli-Led Group ).
3. Amgen got some positive updates over the last week. The company gained EU approval for its blood cancer treatment, Blincyto, as well as for its multiple myeloma treatment, Kyprolis (read more: Amgen's Multiple Myeloma Drug Kyprolis Gains EU Approval ). Moreover, Amgen announced a major formulary win this week with its PCSK9 inhibitor, Repatha, being placed exclusively on CVS/caremark commercial formularies (read more: Amgen's Repatha Gets Preferred Position on CVS Formularies ).
4. Quite a few companies gained EU approval for their treatments over the last five trading days. While Vertex gained approval for its cystic fibrosis treatment, Orkambi (read more: Vertex's Orkambi Approved in EU for Cystic Fibrosis ), Gilead's GILD cocktail HIV drug Genvoya also got approved (read more: Gilead's Cocktail HIV Drug Genvoya Approved in EU ). Moreover, Biogen BIIB got EU approval for its hemophilia A treatment, Elocta.
5. Amgen needs to watch out for potential biosimilar competition for a couple of key drugs in its portfolio - Neulasta and Enbrel. Sandoz, a Novartis company, announced that its regulatory application for the biosimilar version of Neulasta has been accepted for review by the FDA. Sandoz was the first company to launch a biosimilar in the U.S. - a biosimilar version of Neupogen - and the company also has a biosimilar version of Enbrel under FDA review.
Meanwhile, Biogen announced that it has received a positive opinion in the EU for Benepali, a biosimilar version of Enbrel.
Alexion was the highest gainer (3.85%) among major biotech stocks over the last five trading days with Regeneron declining 0.60% during this period. Meanwhile, Biogen lost 26.09% over the last six months with Regeneron being the highest gainer (10.43%) during this period.
The NASDAQ Biotechnology Index was up 1.89% over the last five trading days (See the last biotech stock roundup here: Clovis Plunges, Label Expansion for Gilead's Harvoni ).
Last 6 Months
What's Next in the Biotech World?
A response from the FDA regarding Repros' RPRX enclomiphene product candidate should be out next week.
Meanwhile, quite a few companies will present abstracts at the American Heart Association (AHA) Scientific Sessions 2015.
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