Nuvalent reports $1.4B cash, zidesamtinib PDUFA Sep 18, 2026; pipeline milestones

Nuvalent, Inc.

Preliminary cash, cash equivalents and securities ~$1.4B as of Dec 31, 2025; runway into 2029.
FDA accepted NDA for zidesamtinib in TKI pre-treated ROS1+ NSCLC; PDUFA Sep 18, 2026.
NDA submission for neladalkib in TKI pre-treated ALK+ NSCLC planned for H1 2026.
Potential indication expansion submission for zidesamtinib in TKI-naïve ROS1+ NSCLC in H2 2026.
Progressing ALKAZAR Phase 3 (neladalkib, TKI-naïve ALK+) and HEROEX-1 Phase 1a/1b (NVL-330, HER2-altered NSCLC).

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This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.