FDA delays review of Merus’ zenocutuzumab BLA

Dutch clinical-stage oncology company Merus (Nasdaq|: MRUS), which is developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), today announced that the US Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for zenocutuzumab (Zeno) Biologics License Application (BLA) currently under priority review.

Merus noted that 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. It also pointed out that the agency has not requested any additional clinical data. The company’s shares were down 4.4% at $49.00 in pre-market activity.

Will need a commercial partner for Zeno

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