---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-22-012133"
form_type: "8-K"
ticker: "RLAY"
cik: "0001812364"
company_name: "Relay Therapeutics, Inc."
filed_at: "2022-06-27T23:59:59+00:00"
generated_at: "2026-06-24T23:01:38.764428+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Relay Therapeutics announces FDA alignment on RLY-4008 accelerated path; 62% response rate in CCA

## Summary
- 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.

## SEC filing metadata
- accession: 0000950170-22-012133
- form_type: 8-K
- ticker: RLAY
- cik: 0001812364
- company_name: Relay Therapeutics, Inc.
- filed_at: 2022-06-27T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1812364/000095017022012133/0000950170-22-012133-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1812364/000095017022012133/rlay-20220627.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-22-012133
- JSON: https://secwatch.observer/filing/0000950170-22-012133.json
- Plain text: https://secwatch.observer/filing/0000950170-22-012133.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.