Relay Therapeutics RLAY
Relay Therapeutics (Nasdaq: RLAY) is an oncology drug developer. Its lead program, zovegalisib (RLY-2608), is in Phase 3 for PIK3CA-mutant HR+/HER2- locally advanced or metastatic breast cancer. Its next catalyst on record is zovegalisib (RLY-2608): ReDiscover-2 Trial Phase 3 registrational study ongoing (date not stated).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: zovegalisib (RLY-2608) — ReDiscover-2 Trial Phase 3 registrational study ongoing (date not stated). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| lirafugratinib (LYRFIGTU) | cholangiocarcinoma with FGFR2 fusion or rearrangement | small molecule | Approved |
| zovegalisib (RLY-2608) | PIK3CA-mutant HR+/HER2- locally advanced or metastatic breast cancer | small molecule | Phase 3 |
| zovegalisib (RLY-2608) | PIK3CA-related overgrowth spectrum (PROS) and vascular anomalies | small molecule | Phase 2 |
| RLY-8161 | NRAS-mutant melanoma and other NRAS-mutant solid tumors | small molecule | Phase 1 |
| non-inhibitory chaperone | Fabry disease | protein/peptide | Pre-clinical |
| mutant-selective TIE2 inhibitor | vascular anomalies | small molecule | Pre-clinical |
Recent results and decisions
- Nov 4, 2026approval FDA grants full approval for lirafugratinib (LYRFIGTU) for cholangiocarcinoma with FGFR2 fusion, the first approved molecule discovered by Relay's Dynamo platform.
The FDA granted full approval for LYRFIGTU™ (lirafugratinib) as a treatment option for patients with cholangiocarcinoma (CCA) with FGFR2 fusion or other rearrangement.
Filing - 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
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
- Astrazeneca PLC AZN
- Gilead Sciences, Inc. GILD
- Moderna, Inc. MRNA
- Revolution Medicines, Inc. RVMD
- Genmab A/S GMAB
- BioNTech SE BNTX
- Guardant Health, Inc. GH
- 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.