secwatch.observer — SEC 8-K summary
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Issuer:     Nuvalent, Inc. (NUVL)
CIK:        0001861560
Form:       8-K
Filed at:   2025-11-17T23:59:59+00:00
Accession:  0001193125-25-283893
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 neladalkib in ALK+ NSCLC; ORR 31% in TKI pre-treated, 46% in lorlatinib-naïve
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- Neladalkib achieved 31% ORR (79/253) in TKI pre-treated ALK+ NSCLC; median DOR not reached at 11.3 months follow-up.
- In lorlatinib-naïve subset (n=63), ORR 46% (29/63); DOR ≥12 months 80%. Intracranial ORR 63% with 21% CR.
- Preliminary TKI-naïve cohort (n=44): ORR 86% (38/44), CR 9%, intracranial ORR 78% with 44% CR.
- Safety consistent with ALK-selective design; most common TEAEs: ALT/AST elevations, constipation, dysgeusia. 5% discontinuation.
- Company plans pre-NDA meeting with FDA for TKI pre-treated population; detailed results at future medical meeting.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1861560/000119312525283893/0001193125-25-283893-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1861560/000119312525283893/d23395d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-283893

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