Sarepta Therapeutics Secures Expanded FDA Approval Of ELEVIDYS To Duchenne Muscular Dystrophy Patients Ages 4 And Above
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Sarepta Therapeutics has received expanded FDA approval for its drug ELEVIDYS to treat Duchenne Muscular Dystrophy (DMD) in patients aged 4 and above. The FDA granted traditional approval for ambulatory patients and accelerated approval for non-ambulatory patients, with continued approval contingent on a confirmatory trial. ELEVIDYS is contraindicated for patients with deletions in exon 8 and/or exon 9 in the DMD gene.
June 20, 2024 | 9:04 pm
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Sarepta Therapeutics has received expanded FDA approval for its drug ELEVIDYS to treat Duchenne Muscular Dystrophy in patients aged 4 and above. This includes traditional approval for ambulatory patients and accelerated approval for non-ambulatory patients, contingent on a confirmatory trial.
The expanded FDA approval for ELEVIDYS is a significant milestone for Sarepta Therapeutics, potentially increasing the market for the drug and boosting revenue. The traditional approval for ambulatory patients and accelerated approval for non-ambulatory patients indicate strong confidence in the drug's efficacy, which is likely to positively impact SRPT's stock price in the short term.
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