Novo Nordisk moved to acquire Akero Therapeutics for up to $5.2 billion to add efruxifermin, a Phase III FGF21 analogue that showed fibrosis regression signals in a long Phase IIb SYMMETRY cohort. The deal accelerates Novo’s push into metabolic-associated steatohepatitis (MASH) and late-stage fibrosis, where efruxifermin reported a 96‑week cirrhosis‑reversal signal in treated patients. At the same time the company disclosed that the Indiana manufacturing site it acquired has been classified by the FDA as “official action indicated” (OAI), a regulatory finding that can delay drug approvals and customer supply. The OAI designation follows inspection observations and has already been linked to complete response letters for customers using the facility. Market and program risk now run in parallel: the Akero acquisition gives Novo a late‑stage asset that could expand its MASH franchise beyond incretins, while the OAI raises near‑term execution and manufacturing risk for both Novo and companies relying on that plant.