Update: FDA Delays Decision on Sarepta’s DMD Gene Therapy

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1. The FDA has delayed its decision on Sarepta's gene therapy for Duchenne muscular dystrophy (DMD) until June 22.

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2. The FDA requires additional time to complete the review and finalize label negotiations for Sarepta's gene therapy.

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3. The FDA is working towards potentially granting accelerated approval for SRP-9001, Sarepta's gene therapy for DMD patients aged 4-5 years.

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4. If approved, SRP-9001 would be the first FDA-authorized gene therapy for DMD.

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5. Sarepta's shares dropped 14% in pre-market trading following the news of the FDA's delay.

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6. An FDA advisory committee voted 8-6 in favor of Sarepta's gene therapy for DMD after an all-day meeting.

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7. Sarepta presented evidence supporting the efficacy of its gene therapy, including a video of a successfully treated patient.

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8. Concerns were raised during the meeting regarding Sarepta's trial results and the therapy's efficacy.

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9. The FDA released briefing documents expressing concerns about the safety and effectiveness of Sarepta's gene therapy for DMD.

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10. The FDA is expected to provide its decision on accelerated approval of Sarepta's therapy by May 29.

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