Sarepta Therapeutics, hoping to win approval with a treatment for Duchenne muscular dystrophy, will have to endure a three-month FDA delay before getting final word on its drug.
The FDA is taking a snow day this Friday, abandoning scheduled plans to submit Sarepta's Duchenne muscular dystrophy drug to a review by outside experts.
Sarepta's quest to gain an accelerated approval for eteplirsen was subjected to some harsh scrutiny by regulators at the FDA. And the insiders concluded that much of the data submitted for an approval was a mess, with weak, inconsistent data raising serious questions about the efficacy of the drug.
The FDA is postponing its final decision on BioMarin's treatment for Duchenne muscular dystrophy after taking a dim view of the drug in a staff-prepared review.
The Securities and Exchange Commission has charged a trader with using fraudulent posts on Twitter to manipulate the stock price of Sarepta Therapeutics. James Alan Craig, the man at the center of the case, is alleged to have created a Twitter account that looked like it belonged to securities research firm Citron Research and used it to post lies about Sarepta.
The FDA has awarded priority review status to Sarepta Therapeutics' eteplirsen. The regulatory go sign means Sarepta is still tucked in just behind BioMarin in the race to bring a therapy for Duchenne muscular dystrophy to market, with analysts tipping the agency to make a decision on both drugs by the end of the year.
Sarepta, ending a protracted process that may have cost its last CEO his job, submitted its treatment for Duchenne muscular dystrophy to the FDA, setting the stage for a possible approval early next year.
Chris Garabedian, the bullish, controversial CEO of Sarepta Therapeutics, has resigned from his post, leaving the company just as it prepares to file its Duchenne muscular dystrophy treatment for FDA approval.
In an uncommon move, the FDA has publicly weighed in on an in-development drug, clarifying the status of Sarepta Therapeutics' closely watched Duchenne muscular dystrophy treatment eteplirsen in light of an earlier setback that tanked the biotech's shares.
After a behind-the-scenes squabble spilled out into the public, Sarepta has replaced the chairman of its board and reaffirmed its support of CEO Chris Garabedian, looking to move on from an embarrassing distraction and focus on its lead drug program.