Welcome to our dedicated page for Merus news (Ticker: MRUS), a resource for investors and traders seeking the latest updates and insights on Merus stock.
Merus N.V. (MRUS) is a clinical-stage biotechnology company pioneering bispecific antibody therapeutics for cancer treatment through its Biclonics® platform. This page provides investors and researchers with centralized access to official announcements, clinical trial updates, and strategic developments shaping the company's trajectory in immuno-oncology.
Find timely updates on Merus' investigational therapies, including progress across multiple cancer indications. Track key milestones such as regulatory feedback, partnership expansions with pharmaceutical collaborators, and financial performance updates. Our aggregation ensures efficient monitoring of material events without promotional bias.
Content spans clinical data disclosures, research collaborations with industry leaders like Incyte and Lilly, intellectual property developments, and financial reporting. Each update is categorized for quick scanning while maintaining technical accuracy required for biotech analysis.
Bookmark this page for streamlined access to Merus' evolving story in multispecific antibody development. Combine our news repository with SEC filings and scientific publications for comprehensive investment research approach.
Merus N.V. (Nasdaq: MRUS) has received a second Breakthrough Therapy designation (BTD) from the FDA for petosemtamab in combination with pembrolizumab. This designation is for first-line treatment of adult patients with recurrent or metastatic PD-L1 positive head and neck squamous cell carcinoma (r/m HNSCC) with CPS ≥ 1.
The BTD is supported by updated data from an ongoing phase 1/2 trial, which showed a 67% response rate among 24 evaluable patients. This follows the initial BTD and Fast Track designation received in May 2024 and August 2023 for petosemtamab in treating r/m HNSCC patients whose disease progressed after platinum-based chemotherapy and anti-PD-1 antibody treatment.
The BTD status will expedite development and review processes, providing intensive FDA guidance and eligibility for rolling review and priority review. Merus plans to engage with the FDA as they work toward a potential Biologics License Application (BLA) submission.
Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company specializing in innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), has announced its participation in Citi's 2025 Virtual Oncology Leadership Summit. Bill Lundberg, M.D., President and Chief Executive Officer of Merus, will deliver a presentation on Thursday, February 20, 2025, at 9:00 a.m. ET.
The presentation will be accessible via webcast on the Investors section of the company's website both during and after the event for a time.
Merus N.V. (MRUS) announced the publication of results from their registrational phase 2 eNRGy trial for Bizengri® (zenocutuzumab) in the New England Journal of Medicine. The drug is the first treatment specifically indicated for adults with pancreatic adenocarcinoma or non-small cell lung cancer (NSCLC) harboring NRG1 gene fusion who experienced disease progression after prior therapy.
The study enrolled 204 patients across 12 tumor types, demonstrating durable efficacy particularly in NSCLC and pancreatic adenocarcinoma cases, with a favorable safety profile. In December, Merus licensed exclusive U.S. commercialization rights to Partner Therapeutics.
The drug's safety profile showed notable adverse reactions, including infusion-related reactions in 13% of patients (all Grade 1 or 2), and interstitial lung disease/pneumonitis in 1.1% of patients. The approval is based on overall response rate and duration of response, with continued approval contingent on confirmatory trials.
Merus N.V. (MRUS) and Biohaven (BHVN) have announced a research collaboration and license agreement to co-develop three novel bispecific antibody drug conjugates (ADCs). The partnership combines Merus' Biclonics® technology platform with Biohaven's ADC conjugation and payload platform technologies.
The collaboration includes two Merus bispecific programs and one program under preclinical research. Biohaven will handle preclinical ADC generation under mutually agreed research plans. Both companies will share subsequent external development costs and commercialization upon program advancement.
Merus will receive an upfront payment and license fee at ADC candidate nomination of the first program. Merus will cover preclinical bispecific antibody generation costs, while Biohaven will manage preclinical ADC generation costs.
Merus (NASDAQ: MRUS) has initiated dosing in a Phase 2 trial evaluating petosemtamab as a monotherapy for heavily pretreated metastatic colorectal cancer (mCRC) patients who have received 3 or more lines of therapy. The open-label trial will assess the safety and antitumor activity of petosemtamab, a Biclonics® antibody targeting EGFR and LGR5, in patients who have previously received anti-EGFR therapy and lack certain mutations (KRAS, NRAS) as detected by ctDNA NGS testing. The drug was discovered through screening over 500 bispecific antibodies and has shown superior activity compared to cetuximab in preclinical CRC models.
Merus (MRUS) presented interim clinical data for petosemtamab in treating recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). Key findings include:
- In the 1500 mg Q2W cohort (75 evaluable patients): 36% confirmed overall response rate, including 4 complete responses, with median duration of response of 6.2 months and overall survival of 11.4 months
- In the 1100 mg Q2W cohort (27 evaluable patients): 19% overall response rate, including 2 complete responses
The drug showed a manageable safety profile with infusion-related reactions primarily occurring on day 1 of cycle 1. Clinical trials are ongoing, including phase 3 studies in HNSCC and expanded evaluation in metastatic colorectal cancer, with additional data updates planned for 2025.
Merus (NASDAQ: MRUS) announced FDA approval of BIZENGRI® (zenocutuzumab-zbco), the first and only treatment for adults with NRG1+ pancreatic adenocarcinoma and NRG1+ non-small cell lung cancer (NSCLC) that are advanced unresectable or metastatic. The approval is based on the eNRGy trial results showing a 40% overall response rate in pancreatic cancer patients and 33% in NSCLC patients.
The drug demonstrated duration of response ranging from 3.7 to 16.6 months in pancreatic cancer and a median of 7.4 months in NSCLC. The approval is under accelerated approval pathway, contingent upon confirmatory trials. BIZENGRI® is expected to be available to patients in the coming weeks, with PTx Assist™ program providing patient support.
Merus N.V. (MRUS) has entered into an exclusive license agreement with Partner Therapeutics (PTx) for the U.S. commercialization of zenocutuzumab (Zeno) in NRG1 fusion-positive cancer treatment. PTx will assume full U.S. commercialization rights after a transition period. Merus will receive an upfront payment plus potential milestone payments and high single-digit to low double-digit royalties based on future U.S. sales. Zeno's Biologics License Application is currently under FDA review for treating previously treated NRG1+ non-small cell lung cancer and pancreatic cancer, with potential to be the first targeted therapy for these conditions.
Merus (MRUS) announced updated clinical data for petosemtamab in treating recurrent/metastatic head and neck squamous cell carcinoma (r/m HNSCC). As of November 2023, among 54 patients treated with 1500mg Q2W, 47 were evaluable showing a 40.4% response rate with 7.2 months median duration of response and 12.5 months median overall survival. In a dose comparison study as of March 2024, the 1500mg dose showed stronger efficacy with 5 responses (including 1 complete response) in 12 evaluable patients, compared to 1 confirmed response in 10 patients at 1100mg. The treatment was well-tolerated at both doses with no grade 5 adverse events reported.
Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company specializing in multispecific antibodies, has announced its participation in two upcoming investor conferences. Bill Lundberg, M.D., President and CEO, will participate in a fireside chat at the Guggenheim Securities Healthcare Innovation Conference on Tuesday, November 12 at 9:30 a.m. ET and at the Stifel 2024 Healthcare Conference on Monday, November 18 at 3:00 p.m. ET. Both presentations will be available via webcast on the company's website's Investors page, with archived versions accessible for a time afterward.
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