Spyre’s arthritis misses; Ideaya ends eye cancer trial - Endpoints News
Endpoints News · Nov 4, 2:39 PM
IDEAYA Biosciences Reports Financial Results for the Third Quarter 2026 and Provides a Business Update - PR Newswire
PR Newswire · Nov 3, 11:00 AM
IDEAYA Biosciences is a clinical-stage oncology company developing precision cancer drugs, led by darovasertib for metastatic uveal melanoma; none are approved.
IDEAYA's case rests on darovasertib plus crizotinib in first-line HLA-A*02:01-negative metastatic uveal melanoma. OptimUM-02 met its primary endpoint; NDA completion under RTOR remains expected in the second half of 2026. IDE849's preliminary survival results support diversification, with randomized global registrational trials planned in post-Imdelltra ES-SCLC and NEC. Earlier MTAP programs add options. Cash, equivalents and securities were ~$1.24 billion as of June 30, 2026; management guides into 2030 based on its current operating plan.
Thesis checklist
0 risks need attention
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Next decision point
Tests: The darovasertib NDA is completed and accepted
Does IDEAYA complete the darovasertib-crizotinib NDA, and does FDA accept it for review?
Strong, inconclusive and weak outcomes
What to look for in the result and how each would move the checklist
Price and material events
Select an event marker to read the update below. Marker colors show Thesis status.
IDE849 survival data support diversification; darovasertib NDA completion remains the next milestone
Phase 2/3 win in uveal melanoma sends darovasertib to NDA — approval under single-arm-adjacent RTOR filing determines whether the platform thesis scales
Darovasertib NDA under RTOR in a disease with one approved drug — approval creates the commercial foundation; rejection resets the entire uveal melanoma franchise
Darovasertib's NDA submission for 1L HLA-A2-neg mUM tests whether a Phase 2b/3 PFS win translates to FDA approval in an ultra-orphan indication with no prior systemic standard of care
About this history: every entry shows when the Thesis moved and what it said. The reasoning behind each move (the evidence, the analysis and the source filing) and the earnings write-ups are part of a subscription.
Dates, trials and completed outcomes are open to everyone. What each upcoming milestone hinges on is part of a subscription.
Disease areas: Lung cancer, Breast and gynecologic cancers, Gastrointestinal cancers, Other cancers
Catalyst calendar · Upcoming FDA decisions · Thesis changes
Competitive landscape
6 peers tracked
Cash: Market-data provider estimate; measurement period unavailable.
Debt: Market-data provider estimate; a complete comparable filing balance is unavailable.
Quarterly burn: Estimated from trailing free cash flow; measurement period unavailable.
Net cash and estimated runway require verified matching measurement periods. Missing debt components are not assumed to be zero.
Runway: No underlying guidance available.