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BioMarin (BMRN) FDA Panel Deals with Two Opposing Views - Wedbush

November 25, 2015 7:08 AM EST
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Price: $87.34 -1.43%

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Wedbush analyst Heather Behanna reiterated a Neutral rating and $125 price target on BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) following the Drisapersen AdCom meeting.

Behanna notes that from the start, the panel dealt with two opposing views of the drisapersen data package - on the one hand, BioMarin made a case for the totality of the data on the backdrop of a devastating disease with an evolving understanding on natural history and challenging trial designs. On the other the agency poked holes in the BioMarin story, as expected by the briefing documents, calling the data inconsistent and unconvincing, and the lack of dystrophin data as troubling.

"The panel seemed to be affected by the stories from patients and parents, some getting emotional in their discussion of the data," Behanna commented. "However, despite these anecdotes, it appears to us that the panel was unconvinced of the efficacy of drisapersen. Although the panel did not vote yes or no on approval, we believe the panel was negative on the risk/reward of the drug. In our view, the panel believes the drug works in some patients, it viewed the post-hoc analyses by BioMarin as hypothesis generating and would like to see a study in a population of DMD boys that has a good chance of showing a benefit. We remain on the sidelines for BioMarin and remain cautious on approval by the PDUFA date of December 27th."

For an analyst ratings summary and ratings history on BioMarin Pharmaceutical Inc. click here. For more ratings news on BioMarin Pharmaceutical Inc. click here.

Shares of BioMarin Pharmaceutical Inc. closed at $97.80 yesterday.



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