secwatch.observer — SEC 8-K summary
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Issuer:     Relay Therapeutics, Inc. (RLAY)
CIK:        0001812364
Form:       8-K
Filed at:   2024-09-09T23:59:59+00:00
Accession:  0000950170-24-104557
Event type: other_material
Sentiment:  positive
Materiality: 0.78
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Relay reports positive interim RLY-2608 data: 9.2mo PFS in PI3Kα-mutated breast cancer
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- Median PFS 9.2 months (all mutations) and 10.3 months (kinase mutations) at RP2D in heavily pre-treated patients without PTEN/AKT co-mutations.
- ORR of 33% overall and 53% in kinase mutations; CBR 57%; tumor reductions in 73% of measurable patients.
- Favorable tolerability: 95% median dose intensity, only 2 discontinuations due to TRAEs, 1 Grade 3 hyperglycemia, no Grade 4-5 TRAEs.
- Lirafugratinib: FDA suggests file NDA in cholangiocarcinoma first, then tumor-agnostic sNDA; company seeks global partner.
- Cash runway ~$688M into H2 2026; plan to initiate 2L pivotal study of RLY-2608 in 2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1812364/000095017024104557/0000950170-24-104557-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1812364/000095017024104557/rlay-20240909.htm
  HTML page:      https://secwatch.observer/filing/0000950170-24-104557

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