Quarterly ResultMay 5, 2026, 04:08 PM
Relay Therapeutics' Zovegalisib Gets FDA Breakthrough Therapy Designation
AI Summary
Relay Therapeutics announced that its lead program, zovegalisib, received FDA Breakthrough Therapy designation for PIK3CA-mutant, HR+/HER2- advanced breast cancer. The company also reported first quarter 2026 financial results, with cash, cash equivalents, and investments totaling $642.1 million as of March 31, 2026, providing a runway into 2029. Clinical updates include 11.1-month median PFS for zovegalisib in 2L breast cancer, plans for a Phase 3 1L breast cancer trial in early 2027, and the initiation of a Phase 1/2 trial for RLY-8161 in NRAS-mutant solid tumors.
Key Highlights
- FDA granted Breakthrough Therapy designation to zovegalisib for PIK3CA-mutant, HR+/HER2- advanced breast cancer.
- Zovegalisib doublet showed 11.1-month median PFS in CDK4/6-experienced 2L breast cancer patients.
- Phase 3 1L breast cancer trial for zovegalisib plus atirmociclib expected to start early 2027.
- Initiated Phase 1/2 trial for RLY-8161, an NRAS-selective molecule, in NRAS-mutant solid tumors.
- Cash, cash equivalents, and investments totaled $642.1 million as of March 31, 2026.
- Q1 2026 revenue was $3.0 million, down from $7.7 million in Q1 2025.
- Q1 2026 net loss was $73.3 million, or $0.41 per share.
- Company expects cash, cash equivalents, and investments to fund operations into 2029.