Merus NV

The FDA extended the review period for Merus N.V.'s biologics license application for zenocutuzumab in NRG1 fusion–positive cancer to February 4, 2025, to review submitted Chemistry, Manufacturing, and Controls information without requesting additional clinical data.

The FDA extended the PDUFA target action date for the BLA of zenocutuzumab (MCLA-128) for NRG1-positive NSCLC and pancreatic cancer to February 4, 2025, due to additional CMC review. The BLA is supported by the eNRGy trial data showing ORR of 37.2% in NSCLC and 42.4% in PDAC, with no treatment-related TEAEs leading to discontinuation.

The FDA extended the PDUFA goal date for Merus's zenocutuzumab BLA to Feb 4, 2025, to review recent CMC information. No additional clinical data was requested. Merus emphasizes the importance of a commercialization partnership for NRG1+ cancer patients.

FDA to decide on Journey's rosacea drug DFD-29, Merus' bispecific antibody for NSCLC and PDAC, PTC's gene therapy Upstaza for AADC deficiency, and Autolus' CAR T therapy obe-cel for ALL by November 4, 6, 13, and 16 respectively.

Merus N.V. reports financial results for Q3 2024, highlighting ongoing phase III trials for pétosemtamab in head and neck cancer treatment, with interim clinical data selected for presentation at ESMO® Asia 2024. The company's cash, equivalents, and marketable securities are expected to fund operations until 2028.

Bio-pharma advances in endocrinology, dermatology, cardiovascular, oncology, rare diseases, pulmonology, gastroenterology, and neurology highlight promising therapies like Eli Lilly’s orforglipron, Amgen’s MariTide, Novo Nordisk’s oral semaglutide, Johnson & Johnson’s JNJ-2113, Sanofi’s amlitelimab, Ionis’s olezarsen, BridgeBio’s acoramidis, NewAmsterdam Pharma’s obicetrapib, Jazz Pharmaceuticals’ zanidatamab, Syndax’s revumenib, Merus’ zenocutuzumab, Johnson & Johnson’s nipocalimab, Novo Nordisk’s Mim8, Solid Biosciences’ SGT-003, Merck’s sotatercept, Johnson & Johnson’s Tremfya, and Crossject’s Zepizure, with analyses including clinical data, revenue forecasts, and expected launch dates.

DelveInsight's 'Breast Cancer Pipeline Insight 2024' highlights a robust pipeline with 100+ companies developing 120+ drugs, driven by rising incidence, tech advancements, and increased awareness. Key companies and drugs include Ambrx, CSPC ZhongQi, Merus, and ARX788, DP303c, SHR-A1811, among others. FDA fast-track designations and breakthrough therapy designations for drugs like 9MW2821 and inavolisib underscore significant progress.

S.B., A.D., T.J.F., I.M.G., L.G., R.K.J., G.K., J.M.L., G.V.L., K.P.-J., H.I.S., J.T., R.R.W., M.W., Y.L.W. have disclosed various financial interests, including funding, advisory roles, patents, and equity. C.M.B., E.B., M.W.B., and K.P. declare no competing interests.

Merus N.V. announced the first patient dosed in its phase 3 trial evaluating petosemtamab, a Biclonics® targeting EGFR and LGR5, combined with pembrolizumab for PD-L1+ r/m HNSCC patients.

S.K., D.A.M., J.P., H.S., X.Z., P.H., T.X., and H.S. have financial ties to various pharmaceutical companies, including stock ownership and advisory roles. F.C., J.D., E.V.C., H.S.W., T.Y., R.Y., and J.T. also report consulting or advisory roles and research funding from multiple institutions and companies.