Sarepta Provides Regulatory Update on AMONDYS 45® and VYONDYS 53® [Yahoo! Finance]
Sarepta Therapeutics, Inc. (SRPT)
Last sarepta therapeutics, inc. earnings: 2/26 04:05 pm
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investorrelations.sarepta.com/events-and-presentations
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Source: Yahoo! Finance
CAMBRIDGE, Mass., March 19, 2026 BUSINESS WIRE )--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today provided an update on its ongoing regulatory interactions with the U.S. Food and Drug Administration (FDA) regarding AMONDYS 45 ® (casimersen) and VYONDYS 53 ® (golodirsen) for the treatment of Duchenne muscular dystrophy (DMD). Sarepta requested a meeting with FDA to discuss submitting supplemental new drug applications (sNDA) seeking conversion of the accelerated approvals of AMONDYS 45 and VYONDYS 53 to traditional approvals. This request was supported by data from the ESSENCE confirmatory study; substantial, published real-world evidence supporting treatment; and the favorable safety profiles of both therapies. Sarepta has received feedback from the Agency confirming that we can submit our data from ESSENCE and real-world evidence as part of the sNDAs. The adequacy of the data to support conversion to traditional approval
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News
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- Sarepta to Share First Clinical Data from siRNA Pipeline Targeting FSHD1 and DM1Business Wire
- Sarepta Therapeutics: A $2B Business Priced Like It's Broken [Seeking Alpha]Seeking Alpha
- How FDA Review of Sarepta's ESSENCE Data At Sarepta Therapeutics (SRPT) Has Changed Its Investment Story [Yahoo! Finance]Yahoo! Finance
- Sarepta Therapeutics (SRPT) had its "outperform" rating reaffirmed by Oppenheimer Holdings, Inc.. They now have a $37.00 price target on the stock.MarketBeat
SRPT
Earnings
- 2/25/26 - Miss
SRPT
Sec Filings
- 3/13/26 - Form 4
- 3/13/26 - Form 4
- 3/13/26 - Form 4
- SRPT's page on the SEC website