Hansa Biopharma — Maj 2023
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Sarepta Halted As FDA Mulls Its Highly Anticipated Gene Therapy
Sarepta Stock Catapults Higher After Eking Out A Narrow Win In Its Gene Therapy Battle
Shares of SRPT stock launched Monday after FDA advisors voted late Friday in support of a highly anticipated gene therapy from Sarepta.
Yahoo Finance (finance.yahoo.com)
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UPDATE 1-FDA advisers weigh Sarepta's Duchenne gene therapy
UPDATE 4-US FDA advisers narrowly back Sarepta's Duchenne gene therapy for accelerated approval
Advisers to the U.S. Food and Drug Administration on Friday narrowly recommended that the agency grant accelerated approval to Sarepta Therapeutics Inc's first-of-its-kind gene therapy for Duchenne muscular dystrophy (DMD). Tabassum Ahsan, chair of the panel and vice president of cell therapy operations at California's City of Hope, said she was "very much on the edge" but ended up voting yes.
Yahoo Finance (finance.yahoo.com)
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Aktien er pt. paused. Det skal vi lige huske.
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FDA presentation has concluded. Q&A now. https://twitter.com/maxonwifi/status/1657090567497474050
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Tak exitnu...Jeg følger Q&A. Umiddelbart ser det ikke godt ud for det videre forløb for Sarepta.
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FDA advisors say the benefit-risk profile of SRP-9001 DOES support accelerated approval. The votes:
Yes: 8No: 6
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FDA advisers narrowly vote in favor of Sarepta's DMD gene therapy
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""I think we owe it to the patients to help them intervene," said committee member and consumer representative Kathleen O’Sullivan-Fortin, who voted in favor. Others expressed confidence in the safety profile of the gene therapy even amid concerns about the efficacy."
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Sarepta Therapeutics Announces Positive Vote from U.S. FDA Advisory Committee Meeting for SRP-9001 Gene Therapy to Treat Duchenne Muscular Dystrophy
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