Novo Nordisk received a European regulatory recommendation for FREHEMGO (denecimig), a factor VIIIa mimetic bispecific antibody intended to prevent or reduce bleeding in adults and children with hemophilia A, including patients with inhibitors. The European Medicines Agency’s Committee for Medicinal Products for Human Use based its opinion on the phase 3 FRONTIER program, where denecimig produced mean annualized bleeding rates below one and many participants had no treated bleeds. Separately, Novo signed a multi-target drug discovery and licensing agreement with Eli Lilly-backed Orbis Medicines to develop oral macrocycle treatments for cardiovascular and metabolic diseases. Orbis may receive up to $1.4 billion in upfront and milestone payments, while Novo will make an undisclosed strategic investment. Orbis said its AI-driven nGen platform has produced preclinical macrocycle candidates with oral bioavailability of up to 18%.