FDA Approves Expanded Use For Sarepta's Rare Muscular Dystrophy Gene Therapy
Thursday, the FDA approved labeled indication for Sarepta Therapeutics Inc's SRPT Elevidys (delandistrogene moxeparvovec-rokl) to include individuals with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene who are at least 4 years of age.
Sarepta surges as investors cheer expanded use of gene therapy
Sarepta Therapeutics shares surged about 36% in premarket trading on Friday as an expanded use approval opened up a bigger market in the U.S. for its gene therapy for patients with Duchenne muscular dystrophy (DMD).
Why has the Sarepta stock price (SRPT) gone up more than 35%?
Sarepta Therapeutics (NASDAQ: SRPT), a pharmaceutical company that describes itself as specializing in “precision genetic medicine for rare diseases”, saw its stock price shoot up by 36% in after-hours trading last night. But why? Ground-breaking medical breakthrough Toward the end of the trading day yesterday, Sarepta announced that it had obtained approval from the U.S.
Sarepta Skyrockets After Nabbing A Broad Label For Its Duchenne Gene Therapy
Sarepta rocketed late Thursday after the FDA approved its Duchenne muscular dystrophy gene therapy for all patients age 4 and older.
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.
