Sarepta FDA Safety Concerns

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FDA, Sarepta and Elevidys

Sarepta drops as report suggests FDA needs new trials for Elevidys

Sarepta Therapeutics (NASDAQ:SRPT) resumed its recent sell-off on Thursday after Endpoints News reported that the FDA would require the company to conduct new studies to address safety concerns and reintroduce its gene therapy,

EconoTimes · 21h

FDA Probes Death of 8-Year-Old Linked to Sarepta’s Elevidys Gene Therapy

BioPharma Dive · 5d

5 questions on Sarepta, the FDA and a Duchenne gene therapy crisis

· 6h

What’s behind Sarepta’s gene therapy deaths?

Three patient deaths linked to neuromuscular drugs developed by Sarepta Therapeutics ( NASDAQ: SRPT) have drawn regulatory scrutiny on the viral vector used in the company’s gene therapy platform tech...

STAT · 1d

Europe moves to reject embattled Duchenne muscular dystrophy gene therapy

· 1d

EU panel declines backing Sarepta-Roche gene therapy for Duchenne

Fierce Biotech5d

Sarepta LGMD trials all hit by FDA hold amid newly surfaced safety concerns over gene therapy

The Sarepta saga continues, with the FDA slapping a clinical hold across all of the company’s investigational limb-girdle muscular dystrophy (LGMD) trials, while also revoking the biopharma’s gene therapy platform technology designation.

FDA opens probe into mysterious death linked to gene therapy

The Food & Drug Administration is investigating the death of an 8‑year‑old following Elevidys gene therapy for Duchenne muscular dystrophy. U.S. distribution has been paused amid safety concerns.

BioSpace1d

Sarepta’s Future Increasingly Uncertain as FDA Eyes New Study for Elevidys

CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an anonymous senior FDA official. Given Elevidys’ full approval, however, experts told BioSpace this path would set up a length legal battle between the regulator and

STAT4d

Sarepta Therapeutics’ Duchenne therapy faces ‘arduous’ path back to market, senior FDA official says

Sarepta Therapeutics faces an "arduous path” to try to get its gene therapy for Duchenne muscular dystrophy back onto the market, a senior FDA official told STAT.

4don MSN

Sarepta pares gains as report suggests an ‘arduous’ path for Duchenne drug

Sarepta Therapeutics ( NASDAQ: SRPT) faces an “arduous and treacherous path” to bring its gene therapy Elevidys back to market, according to a STAT report citing a senior FDA official, suggesting the treatment’s license could be revoked amid ongoing safety concerns. The stock was up about 7% in the morning. Now, it is trading flat.