IDEAYA Biosciences, Inc.
IDYANext catalyst
NDA Filing — darovasertib
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Plus 3 more upcoming events in our data (Phase 3 readout, Phase 2 readout).See the timeline
4 upcoming, 2 past
NDA Filing — darovasertib
For metastatic uveal melanoma. IDEAYA Biosciences announced that its OptimUM-02 Phase 3 trial of darovasertib combination met its primary endpoint in metastatic uveal melanoma. The company is filing an NDA under the real-time oncology review program with expected completion in H2 2026.
SourceIDE196 Phase 3 Est. Readout
Estimated primary completion for IDE196 trial (NCT05987332) in Metastatic Uveal Melanoma. Topline data typically follows completion by weeks to months.
SourceIDE196 Phase 2 Est. Readout
Primary completion for IDE196 trial (NCT03947385) in Metastatic Uveal Melanoma
SourceDarovasertib Phase 2 Est. Readout
Primary completion for Darovasertib trial (NCT05907954) in Uveal Melanoma
SourceMarket Overview
Stock performance and key metrics
Crizotinib (Xalkori)
Uveal Melanoma
Darovasertib
Uveal Melanoma
IDE196
Metastatic Uveal Melanoma
Crizotinib
Metastatic Uveal Melanoma
IDE574
ER+, HER 2- Breast Cancer
PD-1 inhibitor
Neoplasms, Colorectal
IDE849
Small-cell Lung Cancer
GSK4418959
Neoplasms, Colorectal
IDE161
Small-cell Lung Cancer
| Drug Name | Phase | Indication | Designations | Patent |
|---|---|---|---|---|
Crizotinib (Xalkori) | Phase 3 | Uveal Melanoma | - | - |
Darovasertib | Phase 3 | Uveal Melanoma | - | - |
IDE196 | Phase 3 | Metastatic Uveal Melanoma | - | - |
Crizotinib | Phase 3 | Metastatic Uveal Melanoma | - | - |
IDE574 | Phase 2 | ER+, HER 2- Breast Cancer | - | - |
PD-1 inhibitor | Phase 2 | Neoplasms, Colorectal | - | - |
IDE849 | Phase 2 | Small-cell Lung Cancer | - | - |
GSK4418959 | Phase 2 | Neoplasms, Colorectal | - | - |
IDE161 | Phase 2 | Small-cell Lung Cancer | - | - |
Source: CatalystAlert database (ClinicalTrials.gov, SEC EDGAR)
Frequently asked questions
What is in IDEAYA Biosciences, Inc.'s drug pipeline?→
CatalystAlert tracks 9 drug candidates in IDEAYA Biosciences, Inc.'s (IDYA) pipeline across Phase 3, Phase 2. Its lead program is IDE196 (Phase 3). Each drug's phase, indication and upcoming catalysts are listed on this page.
When is IDEAYA Biosciences, Inc.'s next FDA catalyst?→
IDEAYA Biosciences, Inc.'s (IDYA) next tracked catalyst is an NDA filing expected Dec 31, 2026. See the catalyst timeline on this page for the full schedule of PDUFA dates, trial readouts and FDA events.
How do I track IDYA biotech catalysts?→
Add IDYA to your CatalystAlert watchlist for alerts ahead of each catalyst, and follow IDEAYA Biosciences, Inc.'s live catalyst calendar, drug pipeline and clinical-trial timeline on this page — sourced from ClinicalTrials.gov, FDA and SEC filings.