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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 commenced a phase 1/2 clinical trial for MCLA-129, a bispecific antibody targeting advanced non-small cell lung cancer (NSCLC) and other solid tumors. This trial aims to evaluate safety, tolerability, and clinical activity, focusing on determining the maximum tolerated dose. MCLA-129, developed in collaboration with Betta Pharmaceuticals, has shown promise in preclinical studies for treating EGFR-resistant NSCLC. This strategic initiative marks a significant advancement in Merus' oncology portfolio, aimed at addressing treatment resistance.
Merus N.V. (Nasdaq: MRUS) announced its selection for an oral presentation at the ASCO Annual Meeting from June 4-8, 2021. The presentation will focus on interim clinical data for zenocutuzumab (Zeno), a bispecific antibody targeting NRG1 fusion positive cancers. Currently, patients are being recruited for the phase 1/2 eNRGy trial assessing Zeno's safety and anti-tumor efficacy. The session will be led by Dr. Alison Schram from Memorial Sloan Kettering Cancer Center and will provide updated analyses on this promising candidate.
Merus N.V. (Nasdaq: MRUS) reported its financial results for Q4 and FY 2020, highlighting advancements in its clinical programs. The clinical update for zenocutuzumab is expected in 2Q 2021, focusing on NRG1 fusion cancers, with over 30 patients involved. Collaboration with Loxo Oncology has resulted in $60 million of upfront payments and equity investment. The company aims to extend its financial runway to at least 2H 2024, supported by cash reserves of $207.8 million. R&D expenses increased by $14.4 million, primarily due to escalating costs for zenocutuzumab.
Merus N.V. (Nasdaq: MRUS) has announced its participation in the AACR 2021 Annual Meeting, presenting preclinical data on its innovative multispecific antibodies, zenocutuzumab and MCLA-129. These presentations, scheduled for April 10-15 and May 17-21, 2021, will focus on the effectiveness of zenocutuzumab against tumors driven by NRG1 gene fusions and MCLA-129's role in impairing NSCLC tumor growth. The company aims to showcase the potential of its Biclonics® technology in cancer therapies.
Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company, announced that CEO Bill Lundberg, M.D., will participate in a fireside chat at the 33rd Annual Roth Conference on March 15, 2021, at 2:00 p.m. ET. The event will be accessible via a live webcast on the Company’s Investors page, with an archived version available for a limited time afterward.
Merus is known for developing innovative, full-length multispecific antibodies, branded as Biclonics® and Triclonics®, which have shown promising features in clinical studies.
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.
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