FDA Accepts sNDA For Amondys and Vyondys; PDUFA Set For Feb 28, 2027

研报英文原文证据摘录

FDA Accepts sNDA For Amondys and Vyondys; PDUFA Set For Feb 28, 2027

Update

June 30, 2026 01:39 PM GMT

Morgan Stanley & Co. LLCMSarepta Therapeutics Inc | North America Michael E Ulz

Equity Analyst

FDA Accepts sNDA For Mike.Ulz@morganstanley.comRohit Bhasin +1 212 761-4650

Research Associate

Rohit.Bhasin@morganstanley.com +1 212 761-0534

Amondys and Vyondys; PDUFA Avraham Novick

Avi.Novick@morganstanley.com +1 212 761-2231

Set For Feb 28, 2027

Sarepta Therapeutics Inc (SRPT.O, SRPT US)

Biotechnology | United States of America

Key Takeaways Stock Rating Equal-weight

Industry View Attractive

FDA accepted sNDAs for Amondys 45 and Vyondys 53 and set a Feb 28, 2027 Price target $25.00

PDUFA date for conversion to full approval. Shr price, close (Jun 29, 2026) $17.02

Mkt cap, curr (mm) $1,842

ESSENCE study showed numerical trends favoring treatment vs placebo, but the 52-Week Range $25.32-10.42

96-week primary endpoint, 4-step ascend velocity, did not reach stat sig.

Mgt. expects full approval due to favorable trends and written FDA agreement

that authorization would be withdrawn only if clinical benefit is not

demonstrated.

We view sNDA acceptance as an incremental positive that supports long-term

positioning of the exon-skipping franchise, while challenges continue for Elevidys.

FDA sets PDUFA target action date of Feb 28. Earlier today, Sarepta announced

FDA acceptance of sNDAs for Amondys 45 and Vyondys 53, with a PDUFA date set

for February 28, 2027, as the company looks for conversion from accelerated to full

approval (press release). The submissions are supported by the ESSENCE

confirmatory study alongside a growing body of real-world evidence and consistent

safety data, with >1,800 patients treated globally across the exon-skipping

franchise.