Nuvalent Announces OnTarget 2026 Operating Plan Progress and Outlines Key Anticipated 2026 Milestones

Core Insights - Nuvalent, Inc. has made significant progress in its pipeline, with the FDA accepting the NDA for zidesamtinib for TKI pre-treated patients with advanced ROS1-positive NSCLC, targeting a PDUFA action date of September 18, 2026 [1][7] - The company plans to submit an NDA for neladalkib in TKI pre-treated advanced ALK-positive NSCLC in the first half of 2026 and aims for an indication expansion of zidesamtinib in TKI-naïve advanced ROS1-positive NSCLC in the second half of 2026 [1][3] - Nuvalent is well-capitalized, ending 2025 with approximately $1.4 billion in cash, which is expected to fund operations into 2029, allowing for a focus on commercial launch and ongoing development [3][2] Pipeline Progress - Zidesamtinib is designed to be a brain-penetrant, ROS1-selective inhibitor, aiming to overcome limitations of existing ROS1 inhibitors and improve treatment options for patients with brain metastases [6] - Neladalkib is also a brain-penetrant, ALK-selective inhibitor, targeting tumors resistant to existing ALK therapies, with a focus on avoiding adverse events related to TRK inhibition [8] - The company is advancing its clinical trials, including the ongoing ALKAZAR Phase 3 trial for neladalkib and the HEROEX-1 Phase 1a/1b trial for NVL-330, which targets HER2-altered NSCLC [3][9] Financial Position - Nuvalent's strong financial position, with a cash runway anticipated into 2029, supports its operational plans and the execution of its first U.S. launch [2][3] - The company is focused on achieving key milestones in 2026, which include potential FDA approvals and the advancement of its drug candidates [2][3]