secwatch.observer — SEC 8-K summary
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Issuer:     Nuvalent, Inc. (NUVL)
CIK:        0001861560
Form:       8-K
Filed at:   2025-06-24T23:59:59+00:00
Accession:  0000950170-25-089213
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

Nuvalent reports positive pivotal data for zidesamtinib in ROS1+ NSCLC; NDA submission set for July 2025
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- Zidesamtinib achieved 44% ORR (51/117) in TKI pre-treated ROS1+ NSCLC; intracranial ORR 48% (27/56) with 20% complete responses.
- In TKI-naïve cohort, preliminary ORR 89% (31/35) with intracranial ORR 83% (5/6) and 67% complete responses; 104 patients enrolled.
- FDA agreed to RTOR for zidesamtinib; rolling NDA to start July 2025, completion targeted Q3 2025, for TKI pre-treated advanced NSCLC.
- ALKAZAR Phase 3 trial of neladalkib vs alectinib in ALK+ NSCLC expected to begin enrollment early H2 2025.
- Zidesamtinib well tolerated: 2% discontinued due to TEAEs; median exposure 5 months; common TEAEs included peripheral edema (36%).

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1861560/000095017025089213/0000950170-25-089213-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1861560/000095017025089213/nuvl-20250624.htm
  HTML page:      https://secwatch.observer/filing/0000950170-25-089213

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