secwatch.observer — SEC 8-K summary
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Issuer:     Quince Therapeutics, Inc. (QNCX)
CIK:        0001662774
Form:       8-K
Filed at:   2025-07-16T23:59:59+00:00
Accession:  0001193125-25-159886
Event type: other_material
Sentiment:  positive
Materiality: 0.70
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Quince completes Phase 3 NEAT enrollment with 105 patients; topline results Q1 2026
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- Enrolled 105 participants total; 83 in primary analysis (ages 6-9), 22 aged 10+.
- Powering at ~90% for primary endpoint; trial under FDA Special Protocol Assessment.
- Topline results expected Q1 2026; NDA submission planned H2 2026 if positive.
- All enrolled participants have elected to transition to open-label extension study.
- FDA Fast Track designation and SPA agreement in place for eDSP in Ataxia-Telangiectasia.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1662774/000119312525159886/0001193125-25-159886-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1662774/000119312525159886/d71020d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-159886

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