Nuvalent Secures Zidesamtinib NDA Acceptance, Raises $500M, Plans 2026 Submissions
Nuvalent’s FDA accepted zidesamtinib NDA for pre-treated ROS1 NSCLC with a September 18, 2026 PDUFA date, and plans neladalkib NDA filing in H1 2026. It raised $500 million and held $1.4 billion cash at year-end, funding operations into 2029 and advancing Phase 3 ALKAZAR and Phase 1 HEROEX-1 trials.
1. Pipeline Milestones
Nuvalent’s NDA for zidesamtinib in pre-treated ROS1-positive NSCLC was accepted by the FDA with a PDUFA date of September 18, 2026. The company plans to file an NDA for neladalkib in TKI pre-treated ALK-positive NSCLC in the first half of 2026 and to submit a label expansion for zidesamtinib in TKI-naïve ROS1 patients in the second half of 2026.
2. Financial Position
In November 2025, Nuvalent raised $500 million through a public offering at $101 per share, boosting its cash, cash equivalents and marketable securities to $1.4 billion as of December 31, 2025. The company expects its financial runway to extend into 2029, supporting planned R&D and commercial preparations.
3. Ongoing Clinical Trials
Enrollment continues in the global Phase 3 ALKAZAR trial comparing neladalkib to alectinib in TKI-naïve advanced ALK-positive NSCLC patients. The Phase 1a/1b HEROEX-1 trial for NVL-330 in HER2-altered NSCLC is ongoing, and Nuvalent aims to disclose a new discovery candidate by year-end 2026.