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Biotech Stocks Facing FDA Decision In June 2024

Sarepta Therapeutics
Sarepta Therapeutics

Sarepta Therapeutics Inc.’s (SRPT) efficacy supplement to the Biologics License Application for Elevidys is under priority review by the FDA, with a decision anticipated on June 21, 2024.

The objectives of the Efficacy Supplement are to broaden the approved indication of Elevidys by removing age and ambulation restrictions and converting the accelerated approval status of the drug to a traditional approval.

Elevidys was granted accelerated approval by the FDA for the treatment of ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene last June.

The drug generated net revenues of $133.9 million for the first quarter of 2024.

SRPT closed Wednesday’s trading at $116.25, up 2.58%.