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
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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
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News
- Merus announces First Patient Dosed in Phase 2 Trial of Petosemtamab in 3L+ mCRCGlobeNewswire
- Merus (MRUS): FDA Approval and Speculative Future in Cancer Therapy [Yahoo! Finance]Yahoo! Finance
- Merus (NASDAQ: MRUS) had its price target raised by analysts at Citigroup Inc. from $89.00 to $97.00. They now have a "buy" rating on the stock.MarketBeat
- Merus (NASDAQ: MRUS) had its "buy" rating re-affirmed by analysts at Needham & Company LLC. They now have a $85.00 price target on the stock.MarketBeat
- Merus' Petosemtamab Monotherapy Interim Data Continues to Demonstrate Clinically Meaningful Activity in 2L+ r/m HNSCC [Yahoo! Finance]Yahoo! Finance
MRUS
Earnings
- 8/1/24 - Miss
MRUS
Sec Filings
- 12/16/24 - Form SCHEDULE
- 12/5/24 - Form 8-K
- 12/2/24 - Form 8-K
- MRUS's page on the SEC website