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

Relay Therapeutics, Inc.

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.

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