Regeneron announces FDA and EMA accept cemdisiran submissions for gMG
NDA under Priority Review with action date November 2026; EU decision expected H2 2027. Cemdisiran could be first siRNA for gMG with subcutaneous dosing four times a year.
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Biopharmaceutical company
regeneron.comLast updated
In short: Regeneron achieved strong Q1 2026 results and FDA approval for the first hearing loss gene therapy, despite a Phase 3 trial failure in melanoma.
NDA under Priority Review with action date November 2026; EU decision expected H2 2027. Cemdisiran could be first siRNA for gMG with subcutaneous dosing four times a year.
The antibody, maftivimab, has shown broad activity against Bundibugyo virus in vitro and will be evaluated in clinical trials.
The EMA accepted the MAA for Otarmeni, a gene therapy for OTOF-related hearing loss, for review under Accelerated Assessment.
Responses were rapid with free light chain normalization by day 15; most patients showed organ improvement. Phase 2 is ongoing for registration.
By Colin Kellaher Regeneron Pharmaceuticals said U.S. and European regulators have accepted its applications seeking approval of its cemdisiran drug candidate in the rare and...
Regeneron Pharma is in focus on Monday after an Ad-hoc-News report said the analyst consensus price target sits at about $792.65, well above the recent...
World Health Organization prioritizes Regeneron’s maftivimab for clinical trials targeting Bundibugy...
It is 10:30 AM and time to call the Annual Meeting of Shareholders of Regeneron Pharmaceuticals Inc. to order. As you have seen in our...
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