Hansa Biopharma — Maj 2023
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Sarepta Therapeutics Announces Update on Regulatory Review of SRP-9001
(05/24/23 8:00 AM EDT)
New regulatory action date is June 22, 2023 ...
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.... CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 24, 2023-- Sarepta Therapeutics, Inc. (NASDAQ: SRPT), the leader in precision genetic medicine for rare diseases, today provided the following update on the Biologics License Application (BLA) for SRP-9001 (delandistrogene moxeparvovec), which is currently under review for the treatment of ambulant individuals with Duchenne muscular dystrophy (DMD) who have a confirmed mutation of the DMD gene.
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Så må vi jo væbne os med lidt yderligere tålmodighed. Men det går vel nok endda.
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UPDATE: FDA needs more time for Sarepta's DMD gene therapy—spurring a deja vu of Exondys 51 (May 24, 2023 08:39am)
"The FDA needs a wee bit more time to consider the approval of Sarepta Therapeutics' gene therapy for Duchenne muscular dystrophy (DMD), however, the agency has indicated an accelerated approval is likely in a restricted age group."
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RBC Capital Markets har sat et nyt Sarepta Therapeutics kursmål på USD 218 med anbefalingen Outperform ... RBC ser en smule negativt på meldingen fra FDA men anbefaler dog at købe på et tilbagefald.
https://pbs.twimg.com/media/FxA6F9NWIAI6SCZ?format=png&name=900x900
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Hansa announces first patient dosed with imlifidase in a global pivotal phase 3 trial in anti-glomerular basement membrane (anti-GBM) disease
(30 May 2023, 08:00)
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