Sarepta Therapeutics Inc. (SRPT)
Sarepta Therapeutics receives expanded approval for Elevidys
Sarepta Therapeutics Inc (NASDAQ: SRPT) rallied a whopping 40% in extended hours today following a key announcement from the U.S. Food and Drug Administration regarding Elevidys. Elevidys is the company's treatment for Duchenne muscular dystrophy.
US FDA approves expanded use of Sarepta's Duchenne gene therapy
The U.S. Food and Drug Administration allowed the expanded use of Sarepta Therapeutics' gene therapy for all patients with Duchenne muscular dystrophy aged four and above on Thursday.
Sarepta Therapeutics: Navigating Elevidys Upside Potential
Sarepta Therapeutics submitted a request to the FDA for label expansion of Elevidys, with a response expected by June 21st. Roche initiated the process for Elevidys marketing authorization application in Europe, expected to be completed by H1 2024. If successful, Elevidys label and geographic expansion is likely to unlock Sarepta's capacity to maintain a strong revenue growth pattern. Thus, supporting a “buy” rating for SRPT.
Sarepta Therapeutics stock to enter S&P MidCap 400: Should you buy?
Sarepta Therapeutics (NASDAQ:SRPT) is set to make a significant move by entering the S&P MidCap 400 index, replacing Shockwave Medical. This change, effective before trading begins on June 3, 2024, follows Johnson & Johnson's acquisition of Shockwave Medical.
