Zenocutuzumab

FDA approves zenocutuzumab-zbco for NRG1 fusion-positive NSCLC and pancreatic adenocarcinoma, based on eNRGy trial results showing ORRs of 33% and 40% respectively, with common adverse effects including increased gamma-glutamyl transferase and decreased hemoglobin.

FDA approves zenocutuzumab for NRG1+ NSCLC and PDAC, supported by phase 1/2 eNRGy trial. It's the first targeted therapy for these cancers, with ORR of 33% in NSCLC and 40% in PDAC.

The FDA approved zenocutuzumab-zbco (Bizengri) for advanced NSCLC and pancreatic adenocarcinoma with NRG1 gene fusion, based on the eNRGy trial showing ORR of 33% in NSCLC and 40% in pancreatic adenocarcinoma. Common adverse effects included diarrhea, musculoskeletal pain, and fatigue.

Canaccord Genuity analyst John Newman maintains a Buy rating on Merus (MRUS) stock, citing the strategic partnership with Partner Therapeutics to commercialize Zenocutuzumab in the US. This collaboration allows Merus to focus on petosemtamab, with Zenocutuzumab's potential US approval and manufacturing issues resolution supporting a positive outlook. Newman sets a $67 price target.

Alligator focuses on mitazalimab for metastatic pancreatic cancer, suspending early-stage projects. Merus' zenocutuzumab PDUFA date extended, but approval still expected.

Novocure's electrical field-emitting device in Phase 3 trial showed extended survival in pancreatic cancer patients when used with chemo; Merus licensed U.S. rights of its cancer drug zenocutuzumab to Partner Therapeutics; FDA to decide on Cytokinetics' heart drug aficamten approval by Sept. 26, 2025; FDA investigates blood cancer cases post-Bluebird bio's Skysona treatment; Fate Therapeutics' CEO Scott Wolchko to retire, with Bob Valamehr taking over in 2025.

November 2024 saw numerous FDA approvals, designations, and clinical trial advancements in oncology, including revumenib for KMT2A-rearranged acute leukemia, obe-cel for relapsed/refractory B-cell ALL, and fast track designations for ALE.P02 in Claudin-1-positive tumors. Other highlights include orphan drug designations for LBL-024 in neuroendocrine cancer and elraglusib in Ewing sarcoma, and a new drug application for sunvozertinib in EGFR-mutant NSCLC.

Merus N.V. licenses U.S. commercialization rights for zenocutuzumab (Zeno) to Partner Therapeutics for NRG1+ cancer, receiving upfront payment, milestones, and royalties. FDA extends PDUFA goal date for Zeno to February 4, 2025. Analyst highlights petosemtamab as Merus's core value driver, with updated clinical data expected to boost shares.

Lung cancer, primarily non-small cell lung cancer (NSCLC), is a leading cause of morbidity and mortality globally. Targeted therapies have emerged as a preferred first-line treatment for NSCLC patients with oncogenic driver mutations, such as EGFR, ALK, ROS1, BRAF, MET, RET, FGFR, and NTRK. These therapies, including small-molecule drugs and monoclonal antibodies, have shown superior efficacy compared to traditional chemotherapy and immunotherapy, particularly in specific molecular subtypes. Challenges remain in drug resistance, adverse effects, and determining optimal treatment sequences. Continued research is essential for advancing precision medicine in lung cancer treatment.

Merus N.V. announced the FDA extended the PDUFA goal date for zenocutuzumab's BLA to February 4, 2025, to review recent CMC information. No additional clinical data were requested. Merus emphasizes the importance of a commercialization partnership for Zeno's potential approval for NRG1+ cancer patients.