Relay Therapeutics, Inc. RLAY
Relay Therapeutics, Inc. (Nasdaq: RLAY) is an oncology drug developer. Its lead program, zovegalisib (RLY-2608), is in Phase 3 for PI3Kalpha-mutated HR+/HER2- locally advanced or metastatic breast cancer (post-CDK4/6 inhibitor).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| zovegalisib + fulvestrant (ReDiscover-2) | PIK3CA-mutant HR+/HER2- advanced breast cancer, post-CDK4/6 | small molecule | Phase 3 |
| zovegalisib (ReInspire) | PIK3CA-related overgrowth spectrum and PIK3CA-driven vascular anomalies | small molecule | Phase 2 |
| zovegalisib + fulvestrant + atirmociclib (triplet) | frontline HR+/HER2- breast cancer | small molecule | Phase 1 |
| RLY-8161 | NRAS-mutant melanoma and other NRAS-mutant solid tumors | small molecule | Phase 1 |
| Fabry disease non-inhibitory chaperone | Fabry disease | small molecule | Pre-clinical |
Recent results and decisions
- Mar 16, 2026positive Median PFS 11.1 months (95% CI 7.3-13.0) at the Phase 3 dose, ORR 43% (15/35), 52% in second line; consistent with 600mg fasted data.
Median progression-free survival (PFS) was 11.1 months (95% CI: 7.3–13.0)
Filing - Feb 3, 2026n/a FDA granted Breakthrough Therapy designation to zovegalisib plus fulvestrant (a designation, not an approval).
the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) to zovegalisib (RLY-2608) in combination with fulvestrant
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 oncology companies
- Merck & Co., Inc. MRK
- Astrazeneca PLC AZN
- Bristol Myers Squibb Co BMY
- BeOne Medicines Ltd. ONC
- Revolution Medicines, Inc. RVMD
- Genmab A/S GMAB
- BioNTech SE BNTX
- Exelixis, Inc. EXEL
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.