Sarepta Announces FDA’s Approval of Updated ELEVIDYS Prescribing Information
Sarepta Therapeutics, Inc. (SRPT)
Last sarepta therapeutics, inc. earnings: 2/26 04:05 pm
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Source: Business Wire
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced an update to the prescribing information for ELEVIDYS (delandistrogene moxeparvovec-rokl), the only approved gene therapy for Duchenne muscular dystrophy (DMD).As previously disclosed, the ELEVIDYS label now includes several key updates, including:A boxed warning for the risk of acute serious liver injury (ALI) and acute liver failure (ALF).The non-ambulatory indication has been removed from the Indication and Usage section of the Prescribing Information. The Company expects to quickly commence a study of an enhanced sirolimus immunosuppressive regimen to address the risk of ALI and ALF so that, with the concurrence of the FDA, dosing may resume for non-ambulatory patients.Expanded guidance for prescribers, including a modified pre- and post-infusion oral corticosteroids regimen, and enhanced monitoring recommendations on a weekly
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News
- Sarepta Announces Approval to Begin ENDEAVOR Cohort 8 to Evaluate Enhanced Immunosuppression Regimen as Part of ELEVIDYS Gene Therapy for Non-Ambulant Individuals with DuchenneBusiness Wire
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- Is Sarepta Therapeutics a Bargain After Its 82% Drop Over the Last Year? [Yahoo! Finance]Yahoo! Finance
- FDA adds strongest warning to Sarepta gene therapy linked to 2 patient deaths [Yahoo! Finance Canada]Yahoo! Finance Canada
SRPT
Earnings
- 11/3/25 - Beat
SRPT
Sec Filings
- 12/2/25 - Form 4
- 11/19/25 - Form 4
- 11/14/25 - Form SCHEDULE
- SRPT's page on the SEC website