Novo Nordisk (NYSE: NVO; Copenhagen: NOVO-B) received Thursday September 17, 2026 a positive EU CHMP opinion recommending marketing authorization for FREHEMGO (denecimig), the company's next-generation factor VIIIa-mimetic bispecific antibody, for treatment of hemophilia A (with or without factor VIII inhibitors) in adults and children. Denecimig offers flexible subcutaneous dosing including once-monthly, every-two-week, or weekly administration in a prefilled-pen presentation. Approval would position denecimig as the second bispecific-antibody FVIIIa mimetic in the European hemophilia A market after Roche's Hemlibra (emicizumab, first launched 2018) — potentially the first meaningful bispecific competition Roche has faced in the Hemlibra franchise. Novo Nordisk expects to launch denecimig in the first European countries in Q4 2026, with broader EU rollout beginning early 2027. The CHMP recommendation is based on data from the Phase 3 FRONTIER program including FRONTIER-2 (adults) and FRONTIER-4 (pediatric) trials. Sandoz-mAbxience separately announced Friday a Hemlibra-referenced biosimilar collaboration, adding a second layer of long-term competitive pressure to the Roche franchise.
Novartis (NYSE: NVS; SIX: NOVN) announced Friday September 18, 2026 that the EMA's CHMP adopted a positive opinion recommending EU marketing authorization for Cosentyx (secukinumab, a fully human IgG1 monoclonal antibody against interleukin-17A) for the treatment of adults with polymyalgia rheumatica (PMR) who have had an inadequate response to steroids or who experience relapse during steroid taper. Upon EC approval, Cosentyx would be the first IL-17A inhibitor licensed in Europe for PMR — a common inflammatory rheumatic disease in adults over 50 with limited advanced treatment options beyond long-term steroids (which carry significant morbidity). The recommendation is anchored on the REPLENISH Phase 3 trial: all primary and secondary endpoints were met across both Cosentyx 300 mg and 150 mg treatment arms, showing doubled sustained remission rates and steroid-sparing benefit versus placebo, with safety consistent with the established Cosentyx profile. European Commission decision is expected by November 2026. Cosentyx generated approximately $6.4 billion in 2025 global sales across its 10+ approved indications.
Zealand Pharma (NASDAQ: ZEAL; NASDAQ Copenhagen: ZEAL) announced Friday September 18, 2026 that the EMA's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending marketing authorization for Zeydovio (glepaglutide, a long-acting next-generation GLP-2 receptor agonist peptide) for the treatment of adults with short bowel syndrome (SBS). The recommendation is anchored on the registrational Phase 3 EASE-1 trial: 65.7% of patients on glepaglutide achieved at least a 20% reduction in parenteral support volume versus 38.9% on placebo, with approximately 1 in 7 patients weaning off parenteral support entirely at 24 weeks. Zeydovio will be supplied as a 10 mg solution for injection in a pre-filled pen. This is the first major CHMP advance in SBS in more than a decade — the current European standard-of-care GLP-2 analog teduglutide (Takeda's Revestive) has been the only GLP-2 in the EU market since 2012. The European Commission decision is expected within approximately 67 days (mid-November 2026 timeframe). Zealand retains full commercial rights in Europe. Glepaglutide is also under FDA review with a U.S. PDUFA action date targeted for early 2027.
Merck (NYSE: MRK; MSD outside North America) and Astellas (TSE: 4503) announced Friday September 18, 2026 that the EMA's CHMP issued a positive opinion recommending EU marketing authorization for Keytruda (pembrolizumab, anti-PD-1 monoclonal antibody) in combination with Padcev (enfortumab vedotin-ejfv, Nectin-4-directed antibody-drug conjugate developed with Pfizer) as perioperative treatment — neoadjuvant before radical cystectomy, continued as adjuvant — for adults with resectable muscle-invasive bladder cancer (MIBC). The recommendation is based on Phase 3 KEYNOTE-B15/EV-304 data documenting statistically significant improvements in event-free survival (primary endpoint), overall survival, and pathologic complete response rate versus neoadjuvant cisplatin-based chemotherapy followed by adjuvant standard of care. European Commission decision is expected in Q4 2026. This would be the first perioperative regimen combining a PD-1 inhibitor with an antibody-drug conjugate to reach European regulatory approval in MIBC and follows the September 2026 FDA approval of the same regimen (plus KEYTRUDA QLEX subcutaneous formulation with berahyaluronidase alfa-pmph) for cisplatin-ineligible MIBC patients.