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) generates frequent news as an oncology company focused on full-length human bispecific and trispecific antibody therapeutics, known as Multiclonics®. Its disclosures highlight clinical progress, regulatory designations, corporate transactions and collaboration updates that are relevant to investors and observers of the biotechnology sector.
A central theme in recent Merus news is the development of petosemtamab (MCLA-158), a Biclonics® antibody targeting EGFR and LGR5. Company announcements describe interim data from phase 2 trials in metastatic colorectal cancer, including combinations with FOLFOX and FOLFIRI and monotherapy in later-line settings, as well as data in recurrent or metastatic head and neck squamous cell carcinoma. News releases detail response rates, safety observations and presentations at major scientific meetings such as the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics and the American Society of Clinical Oncology Annual Meeting.
Another important news stream concerns regulatory and strategic milestones. Merus has reported that the U.S. FDA granted Breakthrough Therapy Designation to petosemtamab in two head and neck cancer settings, and it has provided updates on phase 3 registration trials in first-line and later-line recurrent or metastatic HNSCC. In parallel, the company issues regular financial and business updates, including quarterly results, capital raises, and details on research collaborations with partners such as Incyte, Eli Lilly, Gilead, Ono and Biohaven.
Recent company announcements also cover the agreed acquisition of Merus by Genmab A/S through a cash tender offer and subsequent back-end transactions. Joint releases and 8-K filings describe the tender offer terms, acceptance levels, change of control and plans for a subsequent offering period. For users following MRUS news, this page offers a consolidated view of clinical, regulatory, financial and corporate developments, including the transition of Merus into an indirect wholly owned subsidiary of Genmab.
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Merus N.V. (Nasdaq: MRUS) has reported interim clinical data from the phase 1/2 trial of its bispecific antibody, petosemtamab, in patients with previously treated head and neck squamous cell carcinoma (HNSCC). Key findings include a 37% overall response rate among 43 evaluable patients and a 6-month median duration of response. The trial involved 49 patients, with most having undergone multiple previous treatments. The disease control rate was found to be 72.1%, with promising overall survival metrics. Safety assessments indicated manageable side effects, primarily mild to moderate gastrointestinal and skin reactions. An end-of-phase meeting with the FDA provided insights into the potential registration path for petosemtamab as a treatment for HNSCC. A conference call is scheduled for April 17, 2023, to discuss these results further.
Merus N.V. (Nasdaq: MRUS) reported a robust overall response rate (ORR) of 36% in a trial for the bispecific antibody petosemtamab (MCLA-158) in patients with head and neck squamous cell carcinoma (HNSCC). As of November 28, 2022, 42 evaluable patients showed clinical efficacy, with a median duration of response of 6 months. Following an end-of-phase meeting with the FDA, the company is optimistic about a potential registration path for petosemtamab. The ongoing phase 1/2 trial incorporates a cohort evaluating the drug in combination with Keytruda, targeting a relevant patient population. Merus is set to share more details during a presentation at the AACR Annual Meeting 2023 and on an investor call scheduled for April 17, 2023.
Merus N.V. (Nasdaq: MRUS) announced early clinical data on its bispecific antibody, petosemtamab (MCLA-158), for treating advanced gastric/esophageal adenocarcinoma (GEA) at the AACR Annual Meeting 2023. The treatment targets EGFR and LGR5, showing promise among patients with EGFR gene amplification or overexpression. However, the company has decided to pause further exploration of the GEA cohort to prioritize head and neck squamous cell carcinoma (HNSCC) due to observed strong clinical activity. Clinical data indicated that out of 14 evaluable patients, one achieved a sustained partial response with a 67% tumor reduction, and three experienced stable disease. Petosemtamab demonstrated a manageable safety profile with common adverse events like rash and hypotension. The presentation is scheduled for April 17, 2023.
Merus N.V. (Nasdaq: MRUS) announced the presentation of an abstract on its bispecific antibody MCLA-129 at the AACR Annual Meeting 2023 in Orlando, scheduled for April 18, 2023. MCLA-129 targets EGFR and c-MET, showing enhanced antibody-dependent cellular cytotoxicity compared to amivantamab in preclinical evaluations. The therapy is in clinical trials for treatment of non-small cell lung cancer (NSCLC) and head and neck cancers. Merus holds global rights outside China for MCLA-129, which is co-developed with Betta Pharmaceuticals.