Shanghai RAAS Initiates Phase II Clinical Trial for SR604 Injection

Novo Nordisk announced two European regulatory advances for its Rare Disease portfolio, with the European Medicines Agency's Committee for Medicinal Products for Human Use recommending approval of denecimig, to be marketed as Frehemgo, for hemophilia A in adults and children with or without inhibitors, and issuing a positive opinion for once-weekly Sogroya, or somapacitan, in children with idiopathic short stature or unexplained shortness. Both decisions still require final European Commission action. Novo expects to launch Frehemgo in the first European countries in the fourth quarter of 2026, followed by broader EU availability in early 2027, and denecimig is also under FDA review for the same hemophilia A indication. The Sogroya opinion follows a May 2026 CHMP recommendation for children with short stature born small for gestational age and those with Noonan syndrome, and the pending EC decision will cover all three indications; if approved, Sogroya would become the first and only growth hormone treatment authorized for idiopathic short stature in the EU. Novo generated DKK 9.1 billion in adjusted Rare Disease sales in the first half of 2026, and the segment also includes Alhemo, approved in the United States, Europe, Japan and Australia for routine prophylaxis in patients aged 12 years and older with hemophilia A or B, plus etavopivat, which has completed phase III development in sickle cell disease and phase II development in thalassemia. The Rare Disease push comes as Novo's core GLP-1 franchise faces intensifying competition, with Eli Lilly's Mounjaro generating $18.6 billion in first-half 2026 sales, up 106% year over year, and Zepbound sales rising 60% to $9.1 billion, while Novo's first-half Ozempic sales declined 2% at constant exchange rates and Wegovy product sales increased 7%.