FDA Advisory Committee Discusses Clinical Data Package for BioMarin’s Kyndrisa(TM) (drisapersen) for the Treatment of Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping
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BioMarin (BMRN) Buy Rating Maintained at BofA/Merrill Lynch; FDA Vote Suggests Drisapersen Efficacy Was 'Inconclusive'
November 25, 2015 7:27 AM ESTBofA/Merrill Lynch maintained a Buy rating on BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) with a price target of $165. Comments follow the FDA panel on drisapersen, with votes suggesting that efficacy was inconclusive.
The panel viewed dystrophin as a controversial biomaker, the report... More
BioMarin (BMRN) FDA Panel Deals with Two Opposing Views - Wedbush
November 25, 2015 7:08 AM ESTWedbush 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... More
BioMarin Pharma (BMRN) will resume trading at 7:10am ET
November 25, 2015 6:53 AM ESTBioMarin Pharma (NASDAQ: BMRN) will resume trading at 7:10am EST.
... MoreBioMarin (BMRN) FDA Panel a 'Drisaster' - Oppenheimer
November 25, 2015 6:46 AM ESTOppenheimer analyst Christopher Marai weighed in on BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) following the FDA advisory panel, calling it a "Drisaster!" The panel, he said, puts accelerated approval at risk and DMD strategy in question.
Marai commented, "We attended the FDA advisory meeting... More
BioMarin Pharma (BMRN) Receives Unfavorable View from FDA Panel on Kyndrisa as DMD Treatment
November 25, 2015 6:37 AM ESTBioMarin Pharma (NASDAQ: BMRN) announced today that the Peripheral and Central Nervous System Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) met to discuss the data submitted to support the New Drug Application (NDA) for Kyndrisa (drisapersen) for the treatment of Duchenne muscular dystrophy (Duchenne) amenable to exon 51 skipping. The committee reviewed the Kyndrisa data package, which includes three randomized, placebo controlled trials with more than 300 patients and more than 500 patient years of exposure. The committee discussed the overall strengths and weaknesses of the application but was not asked... More
