Peptide News Digest

#Denecimig

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Regulatory · View digest

FDA Extends Review of Novo Nordisk's Hemophilia A Drug Denecimig Over Manufacturing-Site Fixes; U.S. Launch Now Aimed for First Half of 2027

Novo Nordisk said on Friday, October 2, 2026 that the FDA's review of its biologics license application for denecimig, a bispecific antibody that mimics activated clotting factor VIII in hemophilia A, is still ongoing with no new action date because of remediation work at a manufacturing facility. Novo filed in September 2025 and had expected a decision in the third quarter of 2026; the FDA has not identified deficiencies in the clinical efficacy or safety data, and Novo now aims to launch in the U.S. in the first half of 2027. The company said the delay does not change its 2026 financial outlook.

Regulatory · View digest

Novo Nordisk FREHEMGO (Denecimig), a Factor VIIIa-Mimetic Bispecific Antibody, Receives Positive EU CHMP Opinion for Hemophilia A with Monthly, Every-Two-Week, or Weekly Dosing

Novo Nordisk announced on Thursday, September 17, 2026 that the EMA's CHMP recommended marketing authorization for FREHEMGO (denecimig) to treat hemophilia A, with or without inhibitors, in adults and children. Denecimig is a factor VIIIa-mimetic bispecific antibody that bridges factor IXa and factor X to mimic the cofactor function of activated factor VIII. Novo says it is the first FVIIIa mimetic to offer once-monthly, once-every-two-weeks, and once-weekly prophylaxis in a single-use pre-filled pen. The application was based on the FRONTIER2, FRONTIER3, and FRONTIER4 trials, and FRONTIER5 showed no new safety signals in patients switching from emicizumab. Pending a European Commission decision, Novo expects launches in the first European countries in Q4 2026 and across the EU starting early 2027.