SOUTH SAN FRANCISCO – November 03, 2026 -- IDEAYA Biosciences (Nasdaq: IDYA) completed its first new drug application for darovasertib plus crizotinib in metastatic uveal melanoma during the third quarter, and ended the quarter with $1.15 billion in cash, cash equivalents and marketable securities as of September 30, 2026. Cash runway guidance into 2030 is unchanged.
IDEAYA submits darovasertib NDA to FDA under real-time review program
The filing went to the U.S. Food and Drug Administration under the Oncology Center of Excellence Real-Time Oncology Review (RTOR) program. It rests on two trials presented at ESMO 2026 in Madrid. The OptimUM-01 Phase 2 expansion covered 101 HLA-A*02:01-positive patients, both treatment-naive and second-line patients previously treated with tebentafusp. OptimUM-02 builds on June topline data in treatment-naive HLA-A*02:01-negative patients. In that trial, darovasertib plus crizotinib showed a statistically significant improvement in median progression-free survival over investigator's choice of therapy, by both blinded independent central review and investigator assessment.
IDEAYA closes Phase 3 OptimUM-010 and frees $100-125 million
IDEAYA stopped enrollment in the Phase 3 OptimUM-010 trial, citing ongoing site activation and enrollment challenges. The company estimates cost savings of $100-125 million. It will reallocate the funds to other programs, including potential registrational trials for IDE849 and IDE892.
In primary uveal melanoma, follow-up data from about 119 patients in the Phase 2 OptimUM-09 trial of neoadjuvant single-agent darovasertib showed tumor shrinkage in more than 85% of patients. The enucleation cohort had a 57% eye preservation rate. In the plaque brachytherapy cohort, 74-79% of patients achieved a reduced predicted radiation dose to critical eye structures. IDEAYA plans to submit the published data for inclusion in clinical practice guidelines, which could allow payor coverage in the United States.
With partner Servier, IDEAYA has also started the global Phase 3 OptimUM-011 trial in the adjuvant setting. It will enroll about 450 patients at increased risk of metastasis, irrespective of HLA status, randomized 1:1 to 12 months of the combination or observation. The primary endpoint is relapse-free survival.
Hengrui data show 17.4-month median overall survival for IDE849 in second-line SCLC
Jiangsu Hengrui Pharmaceuticals presented updated Phase 1 data from China for IDE849, a DLL3-directed TOP1 antibody-drug conjugate, in relapsed small cell lung cancer (SCLC) and neuroendocrine carcinomas (NEC). Median overall survival reached 17.4 months in second-line SCLC. Among 19 patients with other NECs, the objective response rate was 52.6% (10/19) and the confirmed rate was 36.8% (7/19). Median progression-free survival was 7.0 months, and the nine-month overall survival rate was 82.4%.
After Type C meetings with the FDA, IDEAYA plans to start two Phase 3 registrational trials of IDE849 by year end, in extensive-stage SCLC and in NEC. The SCLC trial will enroll 400 patients previously treated with tarlatamab, randomized 1:1 to IDE849 or investigator's choice. Objective response rate by blinded independent central review is the primary endpoint for accelerated approval, and median overall survival for full approval. NEC trial design details will follow. First data from IDEAYA's global Phase 1/2 trial are expected by the end of 2026 or early 2027.
Roche and Genentech collaborations anchor IDE892 combination plans in MTAP-deleted cancers
IDEAYA has started monotherapy expansion of PRMT5 inhibitor IDE892 in MTAP-deleted solid tumors, focused on non-small cell lung cancer and pancreatic ductal adenocarcinoma. Target exposures have been reached with 24-hour EC90 coverage, and the maximum tolerated dose has not yet been reached. The company targets a Phase 1 trial of IDE892 with Roche's pan-RAS inhibitor RG6505 in MTAP-deleted, RAS-mutant pancreatic cancer by the end of 2026. Under an August agreement, Genentech will sponsor a trial combining IDE892 with its KRAS G12D inhibitor RG6620, while IDEAYA supplies IDE892.
A Phase 1/2 cohort combining IDE892 with the MAT2A inhibitor IDE397 has been initiated, with expansion planned by the first half of 2027, initially in MTAP-deleted non-small cell lung cancer. IDEAYA will hold an R&D Day on November 16 to present preclinical data on combinations that exploit MTAP/CDKN2A deficiency in KRAS-mutant cancers.
IDEAYA doses first patient in IDE574 plus fulvestrant breast cancer cohort
In October, IDEAYA dosed the first patient in a Phase 1 combination cohort of KAT6/7 inhibitor IDE574 with fulvestrant in ER-positive metastatic breast cancer. The dose-escalation trial also covers prostate, colorectal and lung cancer. Initial Phase 1 dose-escalation data for IDE034, a B7H3/PTK7 bispecific TOP1 antibody-drug conjugate, are planned for 2027.