PDUFA date extended for zenocutuzumab (Zeno) to treat NCSLC/NGR1 positive and pancreatic cancer
Merus N.V. a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), announced that the FDA has extended the Prescription Drug User Fee Act (PDUFA) goal date for zenocutuzumab (Zeno) Biologics License Application (BLA) currently under priority review
The FDA has extended the PDUFA goal date to February 4, 2025 to enable sufficient time to review information recently submitted by the Company in response to a CMC information request. No additional clinical data have been requested. Merus believes that obtaining a commercialization partnership agreement is an important step in bringing Zeno to patients with NRG1+ cancer, if approved.
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