BioCentury
ARTICLE | Company News

BioMarin revenues rise as it awaits DMD meeting

August 4, 2015 12:53 AM UTC

BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) reported earnings and said it is planning an early 2016 launch for drisapersen, its therapy for Duchenne muscular dystrophy amenable to exon 51 skipping. The antisense oligoribonucleotide that induces exon 51 skipping on the dystrophin gene is under Priority Review by FDA with a Dec. 27 PDUFA date; EMA accepted for review an MAA for drisapersen in June.

CEO Jean-Jacques Bienaime reiterated on the earnings call that the company expects FDA to hold an advisory committee committee this year for drisapersen. ...