UTRECHT, The Netherlands and CAMBRIDGE, Mass. - Merus N.V. (NASDAQ:MRUS), a clinical-stage oncology company valued at $3.12 billion and showing remarkable market performance with a 96% return over the past year, announced today that the U.S. Food and Drug Administration (FDA) has approved BIZENGRI® (zenocutuzumab-zbco) for the treatment of adult patients with pancreatic adenocarcinoma and non-small cell lung cancer (NSCLC) that are advanced, unresectable or metastatic and harbor a neuregulin 1 (NRG1) gene fusion. This approval is the first for a therapy specifically targeting NRG1 gene fusions in these cancer types.
The FDA's accelerated approval is based on the overall response rate (ORR) and duration of response (DOR) observed in clinical trials, with continued approval contingent on verification of clinical benefits in confirmatory trials. BIZENGRI® is expected to become available to patients in the United States in the coming weeks. According to InvestingPro analysis, Merus maintains a strong financial position with more cash than debt and a healthy current ratio of 8.32, suggesting robust operational capability for the commercial launch.
Data from the eNRGy trial, which supported the approval, showed an ORR of 40% among 30 patients with NRG1+ pancreatic adenocarcinoma, with a DOR range of 3.7 to 16.6 months. For the 64 patients with NRG1+ NSCLC, the ORR was 33%, and the median DOR was 7.4 months. Adverse reactions were reported in the trial, including diarrhea, musculoskeletal pain, and fatigue, among others.
Dr. Alison Schram, an attending medical oncologist at Memorial Sloan Kettering Cancer Center and a principal investigator for the eNRGy trial, witnessed the clinical outcomes of BIZENGRI® treatment and expressed gratitude for the patients and families who participated in the trial.
The approval of BIZENGRI® also marks a milestone for Merus's proprietary Biclonics® technology platform. The company's Chief Commercial Officer, Shannon Campbell, emphasized the significance of the approval for both the technology and the patients in need of targeted therapy options. While currently not profitable, InvestingPro data shows analysts expect significant revenue growth of 319% for the upcoming year, potentially transforming the company's financial trajectory. For detailed analysis and additional insights, investors can access the comprehensive Pro Research Report, available exclusively to InvestingPro subscribers.
BIZENGRI® is a bispecific antibody that binds to HER2 and HER3, inhibiting dimerization and NRG1 binding, leading to decreased cell proliferation and signaling in cancer pathways. It also mediates antibody-dependent cellular cytotoxicity.
The Personalized Medicine Coalition has applauded the approval, recognizing BIZENGRI® as the sole approved NRG1+ therapy for patients with these challenging cancer types. Merus also plans to offer patient support through PTx Assist™, including educational information and assistance with insurance coverage and financial options.
This approval represents a significant advancement for patients with NRG1+ pancreatic adenocarcinoma and NSCLC, providing a new targeted treatment option. Based on InvestingPro's Fair Value analysis, the stock appears slightly overvalued at current levels, though analysts maintain optimistic price targets. The information reported is based on a press release statement from Merus N.V. Investors seeking deeper insights can access over 12 additional ProTips and comprehensive financial metrics through an InvestingPro subscription.
In other recent news, Merus N.V. has entered into a significant licensing agreement with Partner Therapeutics, Inc. for the development and commercialization of zenocutuzumab, a cancer treatment drug. The company could receive up to $130 million in milestone payments based on annual net sales from this deal. The U.S. Food and Drug Administration has extended the Prescription Drug User Fee Act goal date for the review of Merus's Biologics License Application for zenocutuzumab to February 4, 2025.
In addition, Merus's product, petosemtamab, is showing promise as a therapy for head and neck squamous cell carcinoma, with a Phase 3 trial currently underway. Several analyst firms, including Guggenheim, BMO Capital Markets, H.C. Wainwright, Goldman Sachs, and UBS, have expressed confidence in Merus, maintaining positive ratings and suggesting strong potential for the company's stock.
These are recent developments that highlight the ongoing progress and potential of Merus in the field of oncology.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.