The FDA has extended the Prescription Drug User Fee Act (PDUFA) goal date for Merus N.V.’s zenocutuzumab (Zeno) Biologics License Application (BLA), pushing the decision to February 4, 2025.
The delay will allow the FDA additional time to assess recent information submitted by Merus regarding chemistry, manufacturing, and controls (CMC) for Zeno, a treatment under priority review targeting NRG1+ cancers. The FDA did not request any additional clinical data concerning this extension.
Merus, headquartered in Utrecht, Netherlands, and Cambridge, Massachusetts, specializes in developing bispecific and trispecific antibody therapeutics, known as Multiclonics.
These therapies, engineered to perform like traditional human monoclonal antibodies, have shown promise for durable therapeutic effects with minimal immunogenicity.
