secwatch.observer — SEC 8-K summary
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Issuer:     Nuvalent, Inc. (NUVL)
CIK:        0001861560
Form:       8-K
Filed at:   2023-10-04T23:59:59+00:00
Accession:  0001193125-23-250724
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Nuvalent reports NVL-655 Phase 1 data: 45% ORR in evaluable ALK+ NSCLC patients
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- 57 patients received 15–200 mg once daily; 51% had baseline CNS metastases; 77% post-lorlatinib.
- ORR 45% (15/33) in evaluable ALK+ NSCLC; 65% (11/17) in patients with ALK resistance mutations.
- 41% ORR (12/29) in post-lorlatinib patients, including those with compound resistance mutations.
- No MTD identified; most common TRAEs: nausea (12%), transaminase elevation (12%), fatigue (9%).
- Updated data to be presented Oct 13 at AACR-NCI-EORTC; company to host conference call that day.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1861560/000119312523250724/0001193125-23-250724-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1861560/000119312523250724/d541910d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-23-250724

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