Short answer
Relay Therapeutics, Inc. (RLAY) filed an 8-K current report with the SEC on March 16, 2026 reporting Item 7.01 (Regulation FD Disclosure), Item 8.01 (Other Events). Phase 1/2 ReDiscover trial data released for zovegalisib (RLY-2608) + fulvestrant combo in PI3Kα-mutated HR+/HER2- metastatic breast cancer.
Relay Therapeutics, Inc. 8-K event analysis
AI summary of each reported item and its exhibits
Item 7.01 · Regulation FD Disclosure
- Phase 1/2 ReDiscover trial data released for zovegalisib (RLY-2608) + fulvestrant combo in PI3Kα-mutated HR+/HER2- metastatic breast cancer
- Recommended Phase 3 dose confirmed at 400mg BID with food: key de-risking milestone ahead of potential pivotal trial
- Data readout is a major binary event for RLAY; efficacy/safety results in Exhibit 99.1 will drive near-term stock reaction
- PI3Kα inhibitor class has validated commercial precedent (alpelisib); competitive positioning vs. existing approvals hinges on this data
Item 8.01 · Other Events
- Median PFS 11.1 months at 400mg BID fed dose in 57 efficacy-evaluable PI3Kα-mutated HR+/HER2- metastatic breast cancer patients
- Confirmed ORR 43% overall; 52% in second-line-only patients: clinically meaningful response rates supporting Phase 3 advancement
- 400mg BID fed dose achieves comparable PK exposure to 600mg BID fasted, potentially improving patient convenience and adherence
- Tolerability favorable: only 4 discontinuations due to TRAEs; no Grade 4-5 hyperglycemia observed in 60 treated patients
- Data presented at ESMO TAT 2026 supports zovegalisib as the recommended Phase 3 dose, a key de-risking milestone ahead of pivotal trial
Generated from the filing text and exhibits; verify against the original. What 8-K item codes mean
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