This regulatory relief, combined with several other compelling catalysts, creates a pathway for the stock to potentially ...

FDA evaluating further regulatory actions after deaths Elevidys is the only gene therapy for Duchenne muscular dystrophy Sarepta suggested updating Elevidys' label June 24 (Reuters) - The U.S ...

For a broader perspective on Sarepta’s outlook, explore how other analysts view the stock. Price Action: SRPT stock is trading lower by 9.96% to $17.09 at last check Wednesday.

Sarepta will share the panel’s recommendations with the U.S. Food & Drug Administration (FDA), and implementation of any new regimen will be subject to FDA guidance and allowance. In the ...

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 ...

FDA Grants Platform Technology Status To Sarepta's RAAVrh74 Vector June 04, 2025 — 10:24 am EDT Written by RTTNews.com for RTTNews -> ...

Back in 2020, Sarepta’s then-investigational Elevidys was hit with a regulatory delay as the FDA requested an additional potency assay before the company could start a phase 3 trial.

The rAAVrh74 viral vector is a key component in several of Sarepta’s gene therapy programs, including Elevidys, an already FDA-approved gene therapy for Duchenne muscular dystrophy. It is also ...

Sarepta Therapeutics SRPT announced that the FDA has granted platform-technology designation to its viral vector rAAVrh74, used in the investigational gene therapy SRP-9003.