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0 0.0109040444091991 0.0109040444091991 0.0013877874702617 -0.00872323552735919 -0.00872323552735919 -0.0021808088818398 -0.00872323552735919
Stock impact report

Merus Receives FDA extension of PDUFA for zenocutuzumab

Merus N.V. - Common Shares (MRUS) 
Last merus n.v. - common shares earnings: 8/19 04:01 pm Check Earnings Report
US:NASDAQ Investor Relations: nasdaq.com/symbol/mrus
Company Research Source: GlobeNewswire
UTRECHT, The Netherlands and CAMBRIDGE, Mass., Nov. 05, 2024 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), today announced that the United States 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. The US 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.    About Merus N.V. Merus is a clinical-stage oncology company developing innovative full-length human b Show less Read more
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