secwatch.observer — SEC 8-K summary
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Issuer:     Nuvalent, Inc. (NUVL)
CIK:        0001861560
Form:       8-K
Filed at:   2026-01-14T23:59:59+00:00
Accession:  0001193125-26-012243
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1861560/000119312526012243/0001193125-26-012243-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1861560/000119312526012243/nuvl-20240108.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-012243

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer