Before the Move: Watch BioMarin Into FDA Advisory Committee
BioMarin Pharmaceutical (BMRN) - Get Report , which develops and commercializes pharmaceuticals for serious diseases and medical conditions including Duchenne muscular dystrophy, or DMD, is awaiting an FDA advisory committee for its DMD drug drisapersen, which is brand named Kyndrisa.
WHAT'S NEW: The Peripheral and Central Nervous System Drugs Advisory Committee is meeting on Tuesday, November 24 to discuss the New Drug Application, or NDA, for Biomarin's drisapersen. It is expected that briefing documents related to that meeting will be posted on the FDA's website tomorrow, Friday, November 20.
BULLISH TAKE: On November 15, Leerink analyst Joseph Schwartz said he believes the FDA will feel compelled to approve at least one DMD drug due to "public attention and vocal demand," and says that most likely both drisapersen and Sarepta Therapeutics' (SRPT) - Get Report eteplirsen will be approved. However, he also makes a case where eteplirsen is not approved due to the "extremely limited" clinical data on the drug. Schwartz noted that drisapersen's advisory panel on November 24 happens first and will be important for both companies, adding that he sees "significant" upside potential for BioMarin. On November 18, Goldman Sachs said it views the risk/reward in BioMarin as favorable, with the advisory committee as a key catalyst on the company's path to non-GAAP profitability. Goldman has a Buy rating on BioMarin shares. On November 19, Jefferies analyst Gena Wang wrote that a buy-side survey the firm conducted suggests positive expectations for BioMarin's advisory committee. Wang, who said the survey of 58 investors suggests buy-side expectations of a positive panel for Kyndrisa are 62%, noted that a positive outcome could push BioMarin higher by almost 20%, and positively impact peers PTC Therapeutics (PTCT) - Get Report and Sarepta by over 20% and 6%, respectively.
BAIRD CAUTIOUS: On November 19, Baird analyst Brian Skorney wrote a note titled "A Skeptic's Guide to DMD Regulatory Reviews" where he says the firm has "increasingly come to believe that the FDA is more likely to reject the NDA's for drisapersen and eteplirsen," although he notes the risk reward for BioMarin is skewed to the upside -- with 20% upside potential on approval, but only 10% downside potential on rejection. Baird has a Neutral rating on BioMarin. Skorney sees a 30% probability both drugs get approved during this review period, a 5% chance BioMarin's drug gets approved and Sarepta's gets rejected, a 5% chance Sarepta's gets approved and BioMarin's gets rejected, and a 60% chance that both get rejected.
PRICE ACTION: On Thursday, shares of BioMarin slid about 4.3% to close at $103.11, while shares of rivals Sarepta and PTC Therapeutics dropped 6% and 13%, respectively.
"Before the Move" is The Fly's recurring series of exclusive stories that identify potentially market moving events, along with analyst predictions, ahead of the news. Check back to TheFly.com for more on Biomarin, including analyst reactions to the release of the FDA adcom briefing documents.
Reporting by Eric Buscemi.
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