secwatch.observer — SEC 8-K summary
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Issuer:     Nuvalent, Inc. (NUVL)
CIK:        0001861560
Form:       8-K
Filed at:   2022-10-28T23:59:59+00:00
Accession:  0001193125-22-271664
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Nuvalent reports preliminary Phase 1 data for NVL-520: 48% ORR in heavily pre-treated ROS1+ NSCLC
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- 48% ORR (10/21) in heavily pre-treated ROS1+ NSCLC; 78% (7/9) in G2032R mutation patients.
- Intracranial PRs in 100% (3/3) with measurable CNS mets; 73% (8/11) with CNS history.
- No DLTs, treatment-related SAEs, dizziness, or AEs leading to dose reduction/discontinuation in 35 patients.
- Dose levels 25-125 mg QD achieved exposures above target thresholds; half-life supports once-daily dosing.
- Phase 1 enrollment ongoing; 76% (16/21) of response-evaluable patients continue treatment.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1861560/000119312522271664/0001193125-22-271664-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1861560/000119312522271664/d377694d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-22-271664

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