secwatch.observer — SEC 8-K summary
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Issuer:     Relay Therapeutics, Inc. (RLAY)
CIK:        0001812364
Form:       8-K
Filed at:   2022-09-12T23:59:59+00:00
Accession:  0000950170-22-018311
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 reports 88% interim ORR for RLY-4008 in FGFR2-fusion CCA at pivotal dose
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- 15 of 17 efficacy-evaluable patients at 70 mg QD achieved partial response (88% interim ORR); 14 confirmed, 1 unconfirmed.
- 13 of 15 responders remain on treatment; one patient resected with curative intent; two stable disease patients continue.
- Across all doses/schedules, 24 of 38 FGFRi-naïve FGFR2-fusion CCA patients had partial response (63% interim ORR).
- No Grade 4 or 5 adverse events; off-target toxicities (hyperphosphatemia, diarrhea) clinically insignificant.
- Pivotal cohort enrollment expected to complete in H2 2023; initial non-CCA data and full dose escalation data expected in 2023.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1812364/000095017022018311/0000950170-22-018311-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1812364/000095017022018311/rlay-20220911.htm
  HTML page:      https://secwatch.observer/filing/0000950170-22-018311

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