BioMarin (BMRN) PT Trimmed at Wedbush Following Briefing Docs; Sees Positive Read-Thru to SRPT, None to PTCT
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BioMarin Announces Data Analysis Demonstrating Consistent Efficacy of Kyndrisa™ (drisapersen) in Comparable Patients Across Three Randomized Studies
November 20, 2015 8:11 AM ESTSAN RAFAEL, Calif., Nov. 20, 2015 (GLOBE NEWSWIRE) -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced data analysis for Kyndrisa demonstrating consistent evidence of efficacy in comparable patients across three randomized, placebo-controlled studies that were conducted contemporaneously. Kyndrisa is currently under review with U.S. and European health authorities for the treatment of patients with Duchenne muscular dystrophy who are amenable to exon 51 skipping.  This analysis is included in materials prepared by BioMarin for the November 24, 2015 Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) meeting and can be found on the FDA website at:
... MoreFDA Posts Briefing Documents for Advisory Committee Meeting to Review Kyndrisa™ (drisapersen) for the Potential Treatment of Duchenne Muscular Dystrophy Amendable to Exon 51 Skipping
November 20, 2015 8:10 AM ESTSAN RAFAEL, Calif., Nov. 20, 2015 (GLOBE NEWSWIRE) -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced that the U.S. Food and Drug Administration (FDA) posted briefing materials prepared by BioMarin and by the FDA. The materials pertain to the November 24, 2015 Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) meeting to review the New Drug Application (NDA) for Kyndrisa (drisapersen) for the potential treatment of Duchenne muscular dystrophy (Duchenne) amendable to exon 51 skipping. Â
The PCNS advisory meeting is scheduled for November 24 at 8:00 a.m. to 5:30 p.m. EST. The briefing... More
