secwatch.observer — SEC 8-K summary
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Issuer:     Relay Therapeutics, Inc. (RLAY)
CIK:        0001812364
Form:       8-K
Filed at:   2026-02-03T23:59:59+00:00
Accession:  0001193125-26-034422
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Relay's zovegalisib granted FDA Breakthrough Therapy Designation for PIK3CA-mutant breast cancer
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- FDA granted Breakthrough Therapy Designation to zovegalisib + fulvestrant for PIK3CA-mutant HR+/HER2- advanced breast cancer after CDK4/6i.
- Supported by ReDiscover trial data: 600mg BID fasted (N=52) and 400mg BID fed (N=57, Phase 3 dose) with comparable exposures.
- Phase 3 dose 400mg BID fed data to be presented first at ESMO Targeted Anticancer Congress on March 16, 2026.
- BTD aims to accelerate development and review; provides Fast Track features and enhanced FDA guidance.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1812364/000119312526034422/0001193125-26-034422-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1812364/000119312526034422/rlay-20260203.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-034422

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