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