IDEAYA completes darovasertib NDA, halts Phase 3 OptimUM-010 for enrollment issues
The company reported third-quarter 2026 results alongside an FDA submission, a trial closure expected to save up to $125 million, and $1.15 billion in cash.
IDEAYA Biosciences reported financial results for the third quarter ended September 30, 2026 on November 3, 2026. During the quarter, IDEAYA successfully submitted a new drug application to the FDA to support a potential U.S. approval of the darovasertib combination with crizotinib in metastatic uveal melanoma under the Oncology Center of Excellence Real-Time Oncology Review program.1
The company also disclosed a pipeline setback: due to ongoing site activation and enrollment challenges, IDEAYA decided to stop enrollment and close the Phase 3 OptimUM-010 trial, which is expected to result in estimated cost savings of $100-125 million that the company will reallocate toward other high-value programs, including potential registrational trials for IDE849 and IDE892.1
In the adjuvant setting, IDEAYA and partner Les Laboratoires Servier initiated a global Phase 3 trial, OptimUM-011, following a Type C meeting with the FDA, expected to enroll approximately 450 patients randomized 1:1 to 12 months of the darovasertib combination or observation, with relapse-free survival as the primary endpoint.1
For IDE849, the DLL3 TOP1 ADC, IDEAYA plans to provide first clinical data from its global Phase 1/2 trial in extensive-stage SCLC and NEC by the end of 2026 or early 20271, and plans two Phase 3 registrational trials, including a 400-patient ES-SCLC trial in patients with prior tarlatamab treatment, randomized 1:1 to IDE849 or investigator's choice, with ORR by BICR as the accelerated approval endpoint and median OS for full approval.1
IDEAYA scheduled an R&D Day for November 16, 2026 in London to present preclinical data on exploiting MTAP/CDKN2A deficiency to enhance RAS inhibitor activity in KRAS-mutant cancers.1
On finances, IDEAYA had cash, cash equivalents and marketable securities of approximately $1.15 billion as of September 30, 2026, compared to $1.24 billion as of June 30, 2026, with cash runway guidance into 2030 unchanged based on the current operating plan.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.