Core Viewpoint - Merus N.V. is a clinical-stage oncology company focused on developing innovative multispecific antibodies, with a presentation scheduled at Citi's 2025 Virtual Oncology Leadership Summit [1]. Company Overview - Merus N.V. specializes in full-length human bispecific and trispecific antibody therapeutics, known as Multiclonics® [3]. - The company utilizes industry-standard processes for manufacturing Multiclonics®, which have demonstrated characteristics similar to conventional human monoclonal antibodies, including long half-life and low immunogenicity in preclinical and clinical studies [3]. Event Details - Bill Lundberg, M.D., President and CEO of Merus, will present at the summit on February 20, 2025, at 9:00 a.m. ET [1]. - The presentation will be available via webcast on the company's Investors page, with an archived version accessible for a limited time post-event [2].

Core Viewpoint - Merus N.V. is a clinical-stage oncology company focused on developing innovative multispecific antibodies, with a presentation scheduled at Citi's 2025 Virtual Oncology Leadership Summit [1]. Group 1: Company Overview - Merus N.V. specializes in full-length human bispecific and trispecific antibody therapeutics, known as Multiclonics® [3]. - The company utilizes industry-standard processes for manufacturing Multiclonics®, which exhibit characteristics similar to conventional human monoclonal antibodies, including long half-life and low immunogenicity [3]. Group 2: Event Details - Bill Lundberg, M.D., President and CEO of Merus, will present at the summit on February 20, 2025, at 9:00 a.m. ET [1]. - The presentation will be available via webcast on the company's Investors page, with an archived version accessible for a limited time post-event [2].

Core Insights - Merus N.V. announced the publication of results from the eNRGy trial for Bizengri (zenocutuzumab), the first treatment for adults with advanced unresectable or metastatic pancreatic adenocarcinoma or non-small cell lung cancer (NSCLC) harboring NRG1 gene fusion [1][2][3] Company Overview - Merus is a clinical-stage oncology company focused on developing innovative full-length multispecific antibodies, known as Biclonics and Triclonics [1][29] - The company has made significant progress in its clinical pipeline, emphasizing the importance of its proprietary Biclonics antibody technologies [2] Clinical Trial Results - The eNRGy trial included 204 patients across 12 tumor types, demonstrating durable efficacy of Bizengri in advanced NRG1+ cancers, particularly in NSCLC and pancreatic adenocarcinoma, with a favorable safety profile [3][21] - The trial's main outcome measures were overall response rate (ORR) and duration of response (DOR), assessed by independent central review [21] Treatment Indications - Bizengri is indicated for adults with advanced unresectable or metastatic pancreatic adenocarcinoma or NSCLC with NRG1 gene fusion who have disease progression after prior systemic therapy [5][20] - The treatment received accelerated approval based on ORR and DOR, with continued approval contingent upon further verification of clinical benefit [5] Licensing Agreement - In December, Merus entered into an exclusive licensing agreement with Partner Therapeutics, Inc. for the commercialization of zenocutuzumab in the U.S. [4] Safety and Efficacy - The publication highlights the safety and efficacy of Bizengri, with serious adverse reactions reported in 23% of patients with NRG1+ pancreatic adenocarcinoma and 25% in NRG1+ NSCLC [15][17] - Common adverse reactions included increased alanine aminotransferase (51%), diarrhea (36%), and fatigue (21%) among pancreatic adenocarcinoma patients [16] Mechanism of Action - Bizengri is a bispecific antibody that inhibits HER2:HER3 dimerization and prevents NRG1 binding to HER3, leading to decreased cell proliferation and signaling through the PI3K-AKT-mTOR pathway [20] Patient Demographics - In the NRG1+ pancreatic adenocarcinoma group, the median age was 49 years, with 43% female and 87% White [22] - In the NRG1+ NSCLC group, the median age was 64 years, with 64% female and 56% Asian [23]

Collaboration Overview - Biohaven Ltd and Merus N V announced a research collaboration and license agreement to co-develop three novel bispecific antibody drug conjugates (ADCs) leveraging Merus' Biclonics technology platform and Biohaven's next-generation ADC conjugation and payload platform technologies [1] - The collaboration aims to rapidly advance bispecific antibody candidate ADCs based on the Merus Biclonics platform, combining Merus' validated Biclonics technology with Biohaven's innovative ADC technologies [4][6] Agreement Terms - Biohaven is responsible for the preclinical ADC generation of three Merus bispecific antibodies under mutually agreed research plans [3] - The agreement includes two Merus bispecific programs generated using the Biclonics platform and one program under preclinical research by Merus [3] - Merus will receive an upfront payment and license fee at ADC candidate nomination of the first program, with Merus assuming the preclinical bispecific antibody generation cost and Biohaven assuming the preclinical ADC generation cost [5] - Upon mutual agreement to advance each program, the parties plan to share further development and commercialization costs [5] Technology and Expertise - Merus' Biclonics technology has been validated by the recent FDA approval of Bizengri and continued clinical success with petosemtamab [4][6] - Biohaven brings expertise in ADC research and development, along with a broad range of linker/payload and conjugation technologies [4][6] - The collaboration aims to generate new and differentiated bispecific therapies with greater potency and selectivity over currently available monoclonal ADC approaches [4][6] Company Background - Merus is a clinical-stage oncology company developing innovative full-length human bispecific and trispecific antibody therapeutics, referred to as Multiclonics [9] - Biohaven is a biopharmaceutical company focused on the discovery, development, and commercialization of life-changing treatments in key therapeutic areas, including immunology, neuroscience, and oncology [10] Contact Information - Merus Investor and Media Inquiries: Sherri Spear, SVP Investor Relations and Strategic Communications, 617-821-3246, s spear@merus nl; Kathleen Farren, Assoc Director IR/Corp Comms, 617-230-4165, k farren@merus nl [12] - Biohaven Investor and Media Inquiries: Jennifer Porcelli, Vice President, Investor Relations, jennifer porcelli@biohavenpharma com, +1 (201) 248-0741; Mike Beyer, Sam Brown Inc, mikebeyer@sambrown com, +1 (312) 961-2502 [12]

Core Insights - Merus N.V. has initiated a phase 2 trial for petosemtamab, a novel treatment for heavily pretreated metastatic colorectal cancer (mCRC) [1][2] - Petosemtamab is a Biclonics® antibody targeting EGFR and LGR5, designed to inhibit cancer cell signaling and enhance immune response [4][5] - The trial aims to evaluate the safety and antitumor activity of petosemtamab in patients who have undergone prior anti-EGFR therapy [2][3] Company Overview - Merus N.V. is a clinical-stage oncology company focused on developing innovative bispecific and trispecific antibody therapeutics, known as Multiclonics® [5] - The company utilizes industry-standard processes to manufacture its antibodies, which exhibit characteristics similar to conventional monoclonal antibodies, such as long half-life and low immunogenicity [5] Product Details - Petosemtamab (MCLA-158) is engineered to have three mechanisms of action: inhibiting EGFR signaling, promoting EGFR internalization and degradation, and enhancing antibody-dependent cellular cytotoxicity and phagocytosis [4] - Preclinical studies indicate that petosemtamab shows superior activity compared to cetuximab, a standard treatment for mCRC [3]

Core Insights - Petosemtamab (MCLA-158) demonstrates clinically meaningful efficacy in patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) in a Phase 2 trial, with a 40.4% overall response rate and a median overall survival of 12.5 months [1][3][4] Company Overview - Merus N.V. is a clinical-stage oncology company focused on developing innovative full-length multispecific antibodies, known as Biclonics® and Triclonics® [6] - The company is preparing for a conference call to discuss updated clinical data on petosemtamab, scheduled for December 7, 2024 [2][4] Clinical Data Summary - As of November 6, 2023, 54 patients were treated with 1500 mg of petosemtamab, with 47 evaluable for response, yielding a 40.4% overall response rate [3] - The median duration of response was 7.2 months, median progression-free survival was 5.1 months, and median overall survival was 12.5 months [3] - A new dose-comparison cohort was established with 42 patients randomized to receive either 1500 mg or 1100 mg, showing promising results at both dose levels [3] Safety Profile - Petosemtamab was well tolerated across both dose levels, with no new safety signals reported and no grade 5 treatment-emergent adverse events [3][5] Industry Context - HNSCC is the sixth most common cancer globally, with over 930,000 new cases and 465,000 deaths reported in 2020, and the incidence is expected to rise by 30% by 2030 [4] - Current standard therapies for HNSCC have poor prognosis, highlighting the need for new treatment options like petosemtamab [4]

Core Viewpoint - Merus NV (NASDAQ:MRUS) has seen a positive market reaction following Goldman Sachs' initiation of coverage with a "buy" rating, driven by the potential growth from its cancer treatment [1]. Group 1: Stock Performance - MRUS stock is currently up 3.4% at $44.40, recovering from a recent decline and aiming to end an eight-day losing streak [1][2]. - The stock dropped below its long-term support at the 200-day moving average, which was at $42, coinciding with a pre-bull gap level from April [2]. - Year-to-date, MRUS has increased by 58.3% [2]. Group 2: Analyst Ratings - All 17 analysts covering Merus stock have a "buy" or better rating, indicating strong bullish sentiment [2]. - The 12-month consensus price target for MRUS is $86.60, representing a 98.4% premium to current levels [2]. Group 3: Options Market Sentiment - Options traders are optimistic, with a 50-day call/put volume ratio of 6.88, ranking in the 93rd percentile of its annual range [3].

UTRECHT, The Netherlands and CAMBRIDGE, Mass., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), today announced that Bill Lundberg, M.D., President, Chief Executive Officer of Merus, will participate in the following investor conferences: Guggenheim Securities Healthcare Innovation Conference (fireside chat): Tuesday, November 12 at 9:30 a.m. ETStifel 2024 Healthcare Confer ...

This article is published by Terry Chrisomalis, who runs the Biotech Analysis Central pharmaceutical service on Seeking Alpha Marketplace. If you like what you read here and would like to subscribe to, I'm currently offering a two-week free trial period for subscribers to take advantage of. My service offers a deep-dive analysis of many pharmaceutical companies. The Biotech Analysis Central SA marketplace is $49 per month, but for those who sign up for the yearly plan will be able to take advantage of a 33. ...

UTRECHT, The Netherlands and CAMBRIDGE, Mass., Nov. 05, 2024 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), today announced that the United States Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for zenocutuzumab (Zeno) Biologics License Application (BLA) currently under priority review. The US FDA ha ...