Beyond Otarmeni’s FDA clearance, the broader gene-therapy ecosystem continued to show momentum through manufacturing and delivery partnerships. Andelyn Biosciences and ENCell, both CMOs, announced a collaboration designed to create a U.S.–Asia-Pacific manufacturing bridge to accelerate global gene therapy delivery. The companies said the workflow is intended to streamline a “dual hemisphere” process, enabling in-country manufacturing to support regional clinical trials while reducing lead times and regulatory/logistical friction. Taken together, the approval plus the manufacturing partnership suggests parallel progress: regulators are clearing first gene-therapy wins, while providers are building the operational infrastructure to expand access as more programs move toward commercialization.