Financial StrengthAutolus is well capitalized, with robust financial resources following a strategic partnership with BioNTech, ensuring strong support for the launch of obe-cel and further pipeline development.
Manufacturing And Supply ChainAutolus has achieved a significant milestone by completing its first facility inspection and obtaining a Good Manufacturing Practice (GMP) certificate for the Nucleus site, enabling commercial supply of obe-cel in the US and EU/UK markets.
Regulatory MilestoneObe-Cel is on track with regulatory activities and a set Prescription Drug User Fee Act (PDUFA) date, signaling potential approval and commercialization.