Hansa Biopharma — Maj 2023

[MBCruise]

Tak for link Exitnu - Analytikerne lyder ikke så positive på udfaldet (i linket)

[exitnu]

Selv tak

[exitnu]

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)

[exitnu]

Sarepta: pt. køb i kurs 110,01 & salg i kurs 160

[Helge_LarsenPI-redaktør]

Aktien er pt. paused. Det skal vi lige huske.

[exitnu]

FDA says there isn't persuasive evidence that expression of Sarepta's micro-dystrophin correlates to an improvement in NSAA score.

[Helge_LarsenPI-redaktør]

https://www.fda.gov/media/168021/download

[exitnu]

Max Bayer (staff writer @FierceBiotech covering new drug development)

[Helge_LarsenPI-redaktør]

FDA presentation has concluded. Q&A now. https://twitter.com/maxonwifi/status/1657090567497474050

[exitnu]

Logger ud - god aften til ALLE!

[Helge_LarsenPI-redaktør]

Tak exitnu...Jeg følger Q&A. Umiddelbart ser det ikke godt ud for det videre forløb for Sarepta.

[Helge_LarsenPI-redaktør]

FDA advisors say the benefit-risk profile of SRP-9001 DOES support accelerated approval. The votes:
Yes: 8

No: 6

[exitnu]

FDA advisers narrowly vote in favor of Sarepta's DMD gene therapy

Just a moment...

(www.fiercebiotech.com)

[exitnu]

"Experts from the Cellular, Tissue, and Gene Therapies Advisory Committee narrowly voted 8 to 6 that the benefit-risk profile of SRP-9001 was strong enough to support accelerated approval even as questions about the gene therapy's efficacy linger."

[exitnu]

""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."

[exitnu]

Sarepta Therapeutics Announces Positive Vote from U.S. FDA Advisory Committee Meeting for SRP-9001 Gene Therapy to Treat Duchenne Muscular Dystrophy

https://www.businesswire.com/news/home/20230512005452/en/Sarepta-Therapeutics-Announces-Positive-Vote-from-U.S.-FDA-Advisory-Committee-Meeting-for-SRP-9001-Gene-Therapy-to-Treat-Duchenne-Muscular-Dystrophy

[exitnu]

Så nu er det med at holde øje med mandag d. 29 maj: "The Biologics License Application (BLA) for SRP-9001 is currently under priority review by the FDA with a regulatory action date of May 29, 2023."

[Munchi]

ja lange 14 dage vi skal vente ... 8-6 ikke overbevisende men forhåbentligt ok

[B.Andersen]

Der er vist ikke særlig mange som har fanget det seneste nye omkring Sarepta og FDA. Havde forventet en noget større reaktion i dag.

[Aps_invest]

6,5% op nu….nok mange der har brændt fingrene lidt, og holder sig lidt tilbage Lad os håbe på et lille shorts squeze kan tænde raketten