Nuvalent(US:NUVL) Prnewswire·2025-10-30 10:30Core Insights - Nuvalent, Inc. has completed its rolling NDA submission for zidesamtinib targeting TKI pre-treated advanced ROS1-positive NSCLC, marking a significant milestone in its pipeline [2][6] - The company is on track to report topline pivotal data for neladalkib in TKI pre-treated advanced ALK-positive NSCLC by the end of 2025 [2][6] - Nuvalent maintains a strong financial position with cash runway anticipated into 2028, supporting its transition to a fully integrated commercial-stage biopharmaceutical company [2][5] Pipeline Achievements - The NDA submission for zidesamtinib was supported by data presented at the IASLC 2025 World Conference on Lung Cancer [6] - Preliminary clinical data for neladalkib shows potential in treating advanced ALK-positive solid tumors beyond NSCLC, with ongoing evaluation in the ALKOVE-1 trial [6][7] - The ALKAZAR trial is evaluating neladalkib for TKI-naïve patients with advanced ALK-positive NSCLC, with enrollment ongoing [6][7] Financial Results - As of September 30, 2025, Nuvalent reported cash, cash equivalents, and marketable securities totaling $943.1 million [5][9] - Research and development expenses for Q3 2025 were $83.8 million, while general and administrative expenses were $28.9 million [5][9] - The net loss for Q3 2025 was $122.4 million, compared to a net loss of $84.3 million in Q3 2024 [5][9] Upcoming Events - Management will participate in a fireside chat at the Jefferies 2025 Global Healthcare Conference in London on November 19, 2025 [4]