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Merus N.V. (Nasdaq: MRUS) is a clinical-stage immuno-oncology company focused on creating innovative therapies to treat and potentially cure cancer. At the heart of Merus' approach is its proprietary Biclonics® and Triclonics® technology platforms, which generate full-length human bispecific and trispecific antibodies. These advanced therapeutics are designed to engage the immune system to kill tumor cells and inhibit tumor cell growth pathways simultaneously.
Core Business
Merus' core business revolves around the discovery and development of bispecific antibody therapeutics. Their flagship technology, Biclonics®, can attack tumors in multiple ways, making them highly effective against various cancer types. The company’s portfolio includes several promising candidates, such as MCLA-128, which targets HER2 and HER3 receptors in gastric and breast cancers; MCLA-117, targeting AML; MCLA-158 (petosemtamab), focused on head and neck squamous cell carcinoma; and MCLA-145, developed for solid tumors.
Latest Achievements and News
As of May 2024, Merus has received the FDA's Breakthrough Therapy Designation (BTD) for petosemtamab in treating patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that has progressed after treatment with platinum-based chemotherapy and PD-1/PD-L1 antibodies. This significant milestone is based on the promising data from the ongoing phase 1/2 trial of petosemtamab as a monotherapy, showing substantial improvement in clinically significant endpoints. Furthermore, Merus has announced plans to initiate a phase 3 trial in mid-2024 to evaluate the combination of petosemtamab and pembrolizumab in previously untreated patients.
Additionally, Merus revealed the acceptance of abstracts for MCLA-145 and MCLA-129 at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. These presentations highlighted the clinical activity of MCLA-145 in advanced solid tumors and the efficacy of MCLA-129 in non-small cell lung cancer (NSCLC).
Financial Condition and Partnerships
Merus has a solid financial foundation, bolstered by strategic partnerships and collaborations. Notably, Merus collaborates with Betta Pharmaceuticals to develop MCLA-129 in China while retaining global rights outside China. The company’s financial strategy includes advancing its clinical development programs and supporting preclinical research and technology development through successful capital raises.
About Merus N.V.
Merus N.V. is dedicated to the development of multispecific antibody therapeutics, referred to as Multiclonics®. These therapeutics have been observed in preclinical and clinical studies to exhibit the same features as conventional human monoclonal antibodies, including long half-life and low immunogenicity. For more information, visit Merus’ official website, Twitter, and LinkedIn.
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.
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