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FDA Extends Review For Sarepta Therapeutics' Duchenne Gene Therapy By Couple Of Weeks

  • The FDA informed Sarepta Therapeutics Inc (NASDAQ: SRPT) that it requires modest additional time to complete the review of its SRP-9001 (delandistrogene moxeparvovec) for Duchenne muscular, including final label negotiations and postmarketing commitment discussions.

  • Last week, FDA's Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) voted 8 to 6 in support of accelerated approval of Sarepta's SRP-9001.

  • The agency has extended the review date from May 29 to June 22.

  • Following discussions with FDA, the agency has indicated that subject to the completion of the BLA review, it is working toward potentially granting an accelerated approval for SRP-9001, initially for use in Duchenne patients ages 4-5 years old.

  • EMBARK Phase 3 trial of SRP-9001 is the proposed confirmatory study.

  • Related: Sarepta Therapeutic Shares Surge 25% Following Favorable Gene Therapy Vote; Analyst Anticipates Huge Earnings Swing In 2024.

  • The agency has informed Sarepta that, in addition to confirming the results of the initial BLA approval, if the trial meets its objectives, the agency intends to entertain a non-age-restricted expansion of the SRP-9001 label based on the review of the EMBARK data.

  • EMBARK is fully enrolled, with top-line results expected in the fourth quarter of 2023.

  • Price Action: SRPT shares are down 9.44% at $133 on the last check Wednesday.

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This article FDA Extends Review For Sarepta Therapeutics' Duchenne Gene Therapy By Couple Of Weeks originally appeared on Benzinga.com

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