Tag Archives: srpt

BioMarin, Sarepta Muscular Dystrophy Drugs Progress

Two potential treatments for Duchenne muscular dystrophy inched closer to the U.S. market Monday, as BioMarin Pharmaceutical (BMRN) got an FDA decision date and Sarepta Therapeutics (SRPT) finally completed its application. BioMarin announced that the FDA had accepted its filing of drisapersen, the DMD drug it acquired with its buyout of Prosensa last year, and set itself a deadline to make a ruling by Dec. 27. Since that’s a Sunday, the decision

Sarepta Soars On New Hope For Muscular-Dystrophy Drug

Sarepta Therapeutics (SRPT) stock jumped more than 50% in early trading Wednesday, to an eight-month high, after the company said late Tuesday that the FDA had finally agreed to a refiling plan for its Duchenne muscular dystrophy (DMD) drug eteplirsen. Sarepta said the FDA agreed to a rolling submission plan, with the first batch of data delivered this week and the rest by midyear. That’s in line with previous company guidance, but investors had

Sarepta Revives Hopes For Muscular Dystrophy Drug

Biotech Sarepta Therapeutics (SRPT) said Monday that the FDA sent it detailed guidelines for testing its muscular-dystrophy drug after a previous rejection, leading Sarepta to believe it can file for approval again by the end of the year. Sarepta’s stock was up nearly 50% in midday trading on the stock market today, near 36, a five-month high. Last year, Sarepta attempted to win accelerated approval for the drug, eteplirsen, based on a study