secwatch.observer — SEC 8-K summary
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Issuer:     Nuvalent, Inc. (NUVL)
CIK:        0001861560
Form:       8-K
Filed at:   2026-05-07T23:59:59+00:00
Accession:  0001861560-26-000020
Event type: other_material
Sentiment:  neutral
Materiality: 0.85
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Nuvalent submits NDA for neladalkib in ALK+ NSCLC; zidesamtinib PDUFA Sept 18, 2026
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- NDA for neladalkib in TKI pre-treated ALK+ NSCLC submitted; pivotal data at ASCO 2026.
- Zidesamtinib NDA under FDA review; PDUFA target action date September 18, 2026.
- Plan to submit data in 2H 2026 for zidesamtinib label expansion in TKI-naïve ROS1+ NSCLC.
- Cash $1.3B; net loss $109.3M in Q1 2026 (R&D $83.6M, G&A $35.8M).
- Leadership promotions: Dr. Benjamin Lane to Chief Technology Operations Officer; Dr. Kirsten Duncan to VP Medical Affairs.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1861560/000186156026000020/0001861560-26-000020-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1861560/000186156026000020/nuvl-20260507.htm
  HTML page:      https://secwatch.observer/filing/0001861560-26-000020

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