IDEAYA Biosciences, Inc. IDYA
IDEAYA Biosciences, Inc. (Nasdaq: IDYA) is an oncology drug developer. Its lead program, Darovasertib, is in Phase 3 for Metastatic uveal melanoma. Its next catalyst on record is IDE849: Phase 3 registrational trial initiation in ES-SCLC and NEC (Q4 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: IDE849 — Phase 3 registrational trial initiation in ES-SCLC and NEC (Q4 2026). 5 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Darovasertib | Metastatic uveal melanoma | small molecule | Phase 3 |
| Darovasertib | Adjuvant primary uveal melanoma | small molecule | Phase 3 |
| IDE849 | Extensive-stage small-cell lung cancer | antibody | Phase 1 |
| IDE034 | B7H3/PTK7-expressing tumors | antibody | Phase 1 |
| IDE161 | DLL3-overexpressing solid tumors (combination with IDE849) | small molecule | Phase 1 |
| IDE892 | MTAP-deleted solid tumors | small molecule | Phase 1 |
| IDE397 | MTAP-deleted NSCLC | small molecule | Phase 1 |
| IDE574 | ER+ metastatic breast cancer | small molecule | Phase 1 |
Recent results and decisions
- Nov 3, 2026started IDEAYA plans to initiate two Phase 3 registrational trials with IDE849 in ES-SCLC and NEC by year end.
Following successful Type C meetings with the U.S. FDA, IDEAYA plans to initiate two Phase 3 registrational trials with IDE849 in ES-SCLC and NEC by year end.
Filing - Nov 3, 2026started IDEAYA and Servier initiated global Phase 3 registrational trial OptimUM-011 in adjuvant primary uveal melanoma.
Following completion of a Type C meeting with the FDA earlier this year, IDEAYA and its partner, Les Laboratoires Servier (Servier), initiated a global Phase 3 registrational trial (OptimUM-011) to evaluate the darovasertib combination in the adjuvant setting of primary uveal melanoma.
Filing - Nov 3, 2026started IDEAYA is targeting initiation of Phase 1 trial of IDE892 with RG6505 in MTAP-deleted PDAC by end of 2026.
Pursuant to the clinical collaboration announced with Roche in May, IDEAYA is also targeting initiation of a Phase 1 trial to evaluate IDE892 in combination with RG6505, Roche's Phase 1 pan-RAS inhibitor, in MTAP-deleted, RAS-mutant PDAC by the end of 2026.
Filing
15 more on record.
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
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- 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.