Short answer
Relay Therapeutics, Inc. (RLAY) filed an 8-K current report with the SEC on April 27, 2026 reporting Item 7.01 (Regulation FD Disclosure), Item 8.01 (Other Events), Item EX-99.1 (Exhibit EX-99.1). Phase 1/2 ReDiscover data support advancing zovegalisib plus atirmociclib into Phase 3.
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 data support advancing zovegalisib plus atirmociclib into Phase 3
- Target population: frontline patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer
- Triplet arm included zovegalisib, fulvestrant and atirmociclib
- Phase 3 advancement creates a clinical-development catalyst and future execution risk for Relay Therapeutics
- Data details and development rationale are in Exhibits 99.1 and 99.2
Item 8.01 · Other Events
- Phase 3 planned for zovegalisib plus atirmociclib and aromatase inhibitor in 1L PIK3CA-mutated, HR+/HER2- metastatic breast cancer
- Phase 1/2 ORR 44% in evaluable patients, with 85% experiencing tumor reduction after median 7.4-month follow-up
- Safety included 3% zovegalisib discontinuations and 10% dose reductions; grade 3 hyperglycemia was 0%
- Pfizer will supply atirmociclib and palbociclib; Relay will sponsor and fully fund the Phase 3 trial
- Phase 3 initiation, efficacy, and regulatory progress remain uncertain because data are early and median progression-free survival is not mature
Item EX-99.1 · Exhibit EX-99.1
- Relay plans Phase 3 frontline trial for zovegalisib, atirmociclib and AI in PIK3CA-mutated HR+/HER2- metastatic breast cancer, targeted early 2027
- Triplet produced 44% ORR in median third-line patients, including 44% across kinase and non-kinase PIK3CA mutations
- Tolerability supports frontline testing: 3% discontinued zovegalisib, 10% dose-reduced, and grade 3 hyperglycemia was 0%
- Pfizer supply agreement covers atirmociclib and palbociclib; Relay retains global zovegalisib rights and funds the Phase 3 trial
- Key investment risk: efficacy remains immature, with 7.4-month median follow-up and median progression-free survival not yet estimable
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