secwatch.observer — SEC 8-K summary
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Issuer:     Relay Therapeutics, Inc. (RLAY)
CIK:        0001812364
Form:       8-K
Filed at:   2022-06-27T23:59:59+00:00
Accession:  0000950170-22-012133
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Relay Therapeutics announces FDA alignment on RLY-4008 accelerated path; 62% response rate in CCA
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- FDA aligned on single-arm trial design for RLY-4008 at 70mg QD to potentially support accelerated approval in FGFRi-naïve FGFR2-fusion CCA.
- Interim data: 8 of 13 (62%) FGFRi-naïve FGFR2-fusion CCA patients had confirmed partial responses; all 4 at 70mg QD responded.
- Safety manageable: no Grade 4/5 AEs; off-target hyperphosphatemia and diarrhea clinically insignificant.
- New breast cancer programs: selective CDK2 inhibitor (clinic Q4 2023/Q1 2024), ERα degrader (candidate 2023), pan-mutant PI3Kα RLY-5836 (clinic 2023).
- Cash, cash equivalents and investments expected to fund current operating plan into 2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1812364/000095017022012133/0000950170-22-012133-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1812364/000095017022012133/rlay-20220627.htm
  HTML page:      https://secwatch.observer/filing/0000950170-22-012133

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