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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.
On February 1, 2021, Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company, announced that CEO Bill Lundberg will participate in upcoming investor conferences. Key events include the Guggenheim Healthcare Talks 2021 Oncology Days on February 12, LifeSci Partners Precision Oncology Day on February 17, and the 2021 SVB Leerink Global Healthcare Conference on February 26. Webcasts of the presentations will be accessible via the Company’s Investors page, with archived versions available for a limited time.
Merus N.V. (MRUS) announced an underwritten public offering of 4,848,485 common shares at $24.75 each, aiming for gross proceeds of approximately $120 million. The offering is expected to close around January 25, 2021, pending customary conditions. Merus plans to use the funds for advancing clinical development, preclinical research, and general corporate purposes. The offering includes an option for underwriters to purchase an additional 727,272 shares. Jefferies LLC and SVB Leerink LLC are leading the offering, with a registration statement filed with the SEC for compliance.
Merus N.V. (Nasdaq: MRUS) has announced a proposed underwritten public offering of up to $60 million of its common shares, with an additional $9 million option for underwriters. The offering is subject to market conditions and aims to support the clinical development of its innovative multispecific antibodies, along with preclinical research and working capital needs. Jefferies LLC and SVB Leerink LLC are the joint book-running managers. The shares will be offered under a shelf registration statement filed with the SEC.
Loxo Oncology at Lilly and Merus N.V. announced a collaboration to develop CD3-engaging bispecific antibody therapies. Merus will lead discovery, with Lilly handling development and commercialization. Merus receives $40 million upfront, $20 million equity investment, and up to $1.6 billion in potential milestones for up to three products. This partnership enhances Loxo's biologics strategy. The transaction aligns with Lilly's financial guidance, with no change to 2021 non-GAAP earnings per share expected.
Merus N.V. (MRUS) announced collaborations with key medical organizations in the Netherlands and Japan to promote the eNRGy trial, focusing on identifying NRG1 fusions in cancer patients. The initiative includes support for next-generation sequencing for pancreatic adenocarcinoma patients in both countries. Erasmus MC in the Netherlands and the National Cancer Center in Japan will raise awareness and facilitate screening. The eNRGy trial evaluates zenocutuzumab’s safety and efficacy in treating NRG1+ cancers, aiming to advance patient enrollment in this Phase 1/2 study.
Merus N.V. (MRUS) announced the presentation of clinical data from its Phase 1 dose escalation study of MCLA-158 at the ASCO 2021 Gastrointestinal Cancers Symposium, scheduled from January 15-17, 2021. MCLA-158, a bispecific antibody targeting EGFR and LGR5, was reported to be well-tolerated, successfully reaching the recommended phase 2 dose. The ongoing dose expansion phase includes patient enrollment for gastric and other non-CRC cancers, indicating progress in their clinical development efforts.
Merus N.V. (Nasdaq: MRUS) announced that the FDA has granted Fast Track Designation to its drug Zenocutuzumab (Zeno) for treating metastatic solid tumors with NRG1 gene fusions. This designation aims to expedite development for serious conditions with unmet needs. The ongoing Phase 1/2 eNRGy trial is evaluating Zeno monotherapy across different cancer types including non-small cell lung and pancreatic cancer. The company anticipates providing updates in the second quarter of 2021.
Merus N.V. (Nasdaq: MRUS) has announced a strategic agreement with Sema4 to utilize advanced genomic testing to identify patients with neuregulin 1 gene (NRG1) fusions for the Phase 1/2 eNRGy clinical trial of Zenocutuzumab (Zeno). The collaboration aims to enhance enrollment by identifying candidates with advanced NRG1+ solid tumors, including pancreatic and non-small cell lung cancers. Zeno targets NRG1 fusions, which are actionable drivers in various cancers. This partnership aligns with Merus’ goal to provide new treatment options and accelerate clinical trial participation.
Merus (Nasdaq:MRUS), a clinical-stage oncology company, announced that CEO Dr. Bill Lundberg will participate in a fireside chat at the Jefferies Virtual London Healthcare Conference on November 17, 2020, at 14:40 GMT. A live webcast of the presentation will be accessible on the company's Investors page, with an archived version available for a limited time.
Merus specializes in developing innovative multispecific antibodies known as Biclonics® and Triclonics™ that demonstrate characteristics similar to traditional human monoclonal antibodies.
Merus N.V. (Nasdaq: MRUS) announces the presentation of preclinical data for its bispecific antibody MCLA-145 at the Society for Immunotherapy of Cancer (SITC) annual meeting from November 10-15, 2020. MCLA-145 targets CD137 on T cells and PD-L1 on cancer cells, demonstrating a potent anti-tumor effect without the safety issues seen with other CD137 agonists. Currently, MCLA-145 is in a Phase 1 dose escalation study for patients with solid tumors, co-developed with Incyte, which handles commercialization outside the U.S.
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