Merus N.V. Common Shares - MRUS STOCK NEWS

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.

Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company specializing in innovative multispecific antibodies, has announced its participation in Canaccord Genuity's 44th Annual Growth Conference. Bill Lundberg, M.D., President and CEO of Merus, will present on Tuesday, August 13, 2024, from 9:00-9:25 a.m. ET.

The presentation will be webcast live on the Investors page of the Merus website and will remain available for a time after the event. This conference provides Merus with an opportunity to showcase its progress in developing Biclonics® and Triclonics®, their full-length multispecific antibody platforms, to potential investors and industry professionals.

Merus N.V. (NASDAQ: MRUS) announced financial results for Q2 2024 and provided a business update. Key highlights include:

• Petosemtamab showed a 67% response rate in combination with pembrolizumab in 1L HNSCC
• First patients dosed in phase 3 trial for petosemtamab monotherapy in 2/3L HNSCC
• Successful public offering raising $460M gross proceeds
• Cash runway extended into 2028
• FDA accepted BLA for zenocutuzumab in NRG1+ NSCLC and PDAC for priority review

As of June 30, 2024, Merus had $846.4 million in cash and equivalents. Q2 2024 saw collaboration revenue decrease by $3.2M, while R&D expenses increased by $20.8M and G&A expenses rose by $6.5M compared to Q2 2023.

Merus N.V. (Nasdaq: MRUS) has announced the dosing of the first patient in its phase 3 trial (LiGeR-HN2) evaluating petosemtamab in previously treated recurrent/metastatic head and neck squamous cell carcinoma (r/m HNSCC). The trial will compare petosemtamab to investigator's choice of single agent chemotherapy or cetuximab. The FDA has confirmed that the 1500 mg every two weeks dosage is appropriate for further development in HNSCC as monotherapy and in combination with pembrolizumab. This dosage will be used in both the 2/3L phase 3 trial (LiGeR-HN2) and the 1L trial (LiGeR-HN1) in r/m HNSCC. Merus believes petosemtamab has the potential to become the new standard of care across r/m HNSCC.

Merus announced the dosing of the first patient in its phase 2 trial of petosemtamab combined with standard chemotherapy for second-line metastatic colorectal cancer (mCRC). The trial will assess safety and preliminary antitumor activity in approximately 40 patients previously untreated with EGFR inhibitors and without KRAS mutations. This study marks a significant step in Merus' oncology program, expanding from head and neck cancer to mCRC.