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

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

BioMarin (BMRN) Buy Rating Maintained at BofA/Merrill Lynch; FDA Vote Suggests Drisapersen Efficacy Was 'Inconclusive'

November 25, 2015 7:27 AM EST

BofA/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 Pharma (BMRN) will resume trading at 7:10am ET

November 25, 2015 6:53 AM EST

BioMarin Pharma (NASDAQ: BMRN) will resume trading at 7:10am EST.

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BioMarin (BMRN) Panel Negative, But Less than FDA - Baird

November 25, 2015 6:50 AM EST

Baird analyst Brian Skorney weighed in on BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) following yesterday's negative AdCom. However, the analyst said the panel was not as negative as the FDA.

"We spent yesterday at FDA for the drisapersen AdCom. The panelists... More

BioMarin (BMRN) FDA Panel a 'Drisaster' - Oppenheimer

November 25, 2015 6:46 AM EST

Oppenheimer 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 EST

BioMarin 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