Merus Stock Price, News & Analysis

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.

Merus announced that the FDA has extended the PDUFA goal date for zenocutuzumab (Zeno) Biologics License Application, currently under priority review. The new PDUFA date is February 4, 2025, allowing time to review recently submitted CMC information. No additional clinical data were requested. The company emphasizes that securing a commercialization partnership is important for making Zeno available to NRG1+ cancer patients, pending approval.

Merus N.V. (NASDAQ: MRUS) reported Q3 2024 financial results and business updates. The company's phase 3 trials for petosemtamab in head and neck cancer are progressing, with clinical data updates expected at ESMO Asia in December 2024. The FDA has accepted Zeno BLA for priority review in NRG1+ NSCLC and PDAC cancer. Financial highlights include $782.9 million in cash, cash equivalents, and marketable securities, expected to fund operations into 2028. Q3 collaboration revenue increased by $0.8 million year-over-year, while R&D expenses increased by $26.5 million and G&A expenses rose by $8.2 million.

Merus N.V. (Nasdaq: MRUS) has announced the dosing of the first patient in its phase 3 trial called LiGeR-HN1. This trial evaluates the efficacy and safety of petosemtamab, a Biclonics® targeting EGFR and LGR5, in combination with pembrolizumab, compared to pembrolizumab alone as first-line therapy for patients with PD-L1+ recurrent/metastatic head and neck squamous cell carcinoma (r/m HNSCC).

The company has received confirmation from the U.S. Food and Drug Administration (FDA) that petosemtamab 1500 mg every two weeks is appropriate for further development in HNSCC as monotherapy and in combination with pembrolizumab. Merus' CEO, Bill Lundberg, expressed confidence in petosemtamab's potential to become a new standard of care across r/m HNSCC and possibly beyond, based on strong phase 2 clinical data.

Merus N.V. (Nasdaq: MRUS) announced the acceptance of an abstract on petosemtamab, their Biclonics® antibody targeting EGFR and LGR5, for presentation at the ESMO® Asia Congress 2024. The presentation will focus on interim clinical data of petosemtamab monotherapy in previously treated (2L+) recurrent/metastatic head and neck squamous cell carcinoma (r/m HNSCC).

Key points:

• Presentation scheduled for December 7, 2024, at 3:25-3:30 p.m. SGT
• Updated efficacy, durability, and safety data will be presented
• Previous data showed a 37% response rate among 43 evaluable patients
• FDA feedback confirmed 1500 mg every two weeks as appropriate for further development
• Two phase 3 trials are ongoing or planned: LiGeR-HN2 (2/3L) and LiGeR-HN1 (1L in combination with pembrolizumab)

Foundation Medicine has announced a collaboration with Merus N.V. (Nasdaq: MRUS) to develop an RNA platform as a companion diagnostic for Merus's bispecific antibody zenocutuzumab (Zeno). This diagnostic aims to treat patients with neuregulin 1 fusion (NRG1+) cancer. Zeno, which utilizes Merus's Dock & Block® mechanism, inhibits the neuregulin/HER3 tumor-signaling pathway in solid tumors with NRG1 fusions.

The FDA has accepted a Biologics License Application for Zeno under priority review for NRG1+ non-small cell lung cancer (NSCLC) and NRG1+ pancreatic cancer (PDAC). Zeno has also received Breakthrough Therapy Designation for advanced unresectable or metastatic NRG1+ pancreatic cancer and NSCLC. Foundation Medicine's RNA platform offers sophisticated fusion detection in 318 genes through RNA sequencing, potentially helping to detect more NRG1 fusions and inform patient care decisions.