News
FDA launches probe into new Elevidys death as Sarepta, Roche stress gene therapy not at fault
In its own communique issued shortly after the FDA’s, Sarepta elaborated on the situation and confirmed a Roche statement to Bloomberg News that linked the probe to a fatality in Brazil and held that the death of the patient was unrelated to Elevidys itself.
Sarepta Shares Rise After Company Says It Will Resume Elevidys Shipments
But uncertainty remains around the FDA's decision-making and whether patient demand for Elevidys will remain, the analysts said. The company voluntarily paused Elevidys shipments for ambulatory patients last week after previously rejecting the FDA's request that it do so.
CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...
The FDA has placed multiple investigational gene therapy clinical trials on hold, signaling broader platform concerns.
Wall Street analysts were quick to downgrade Sarepta Therapeutics (NASDAQ:SRPT) on Monday as the company suspended its revenue guidance for 2025 following a second fatality linked to Elevidys, its ...
Shares of Sarepta Therapeutics closed down as much as 42% to hit a nine-year low of $18.30 on Monday after a second death of a male teenage patient who had received its gene therapy, Elevidys ...
Results that may be inaccessible to you are currently showing.
Hide inaccessible results
Feedback