IDEAYA Biosciences, Inc. develops precision medicine oncology therapies for molecularly defined cancer populations. The company’s news centers on targeted small-molecule programs, synthetic lethality research, antibody-drug conjugates and biomarker-guided clinical development across solid tumors.
Recurring updates include darovasertib clinical data in uveal melanoma, including combination work with crizotinib, as well as pipeline developments for programs such as IDE849, IDE161, IDE574 and IDE397. Company announcements also cover medical-meeting presentations, FDA regulatory interactions, clinical collaboration activity, quarterly financial results, cash runway commentary and equity compensation grants under Nasdaq inducement rules.
IDEAYA Biosciences (NASDAQ: IDYA) will participate in investor events in London on November 16 and 17, 2026, including an Investor R&D Day.
On November 16, CEO Yujiro S. Hata will join a UBS Global Biopharma Conference fireside chat, followed by the company's R&D Day. The R&D agenda includes a summary of IDE892 Phase 1 dose-escalation data, RAS research, preclinical combination strategies and targeted 2027 clinical updates and milestones. Hata, R&D President Michael White and CFO Joshua Bleharski will participate in the Jefferies Global Healthcare Conference on November 17. Live webcasts will be available, with replays accessible for 30 days.
IDEAYA Biosciences (Nasdaq: IDYA) reported a third-quarter net loss of $125.7 million while completing its first darovasertib approval application. Collaboration revenue rose to $10.2 million from $8.9 million in the second quarter, while the net loss widened from $112.5 million. Cash, cash equivalents and marketable securities totaled approximately $1.15 billion at September 30, down from $1.24 billion at June 30; the company maintained cash runway guidance into 2030.
The FDA application seeks approval of darovasertib plus crizotinib for metastatic uveal melanoma. Enrollment challenges prompted closure of Phase 3 OptimUM-010; IDEAYA expects estimated savings of $100-125 million for other pipeline programs. A separate adjuvant Phase 3 trial has begun. IDEAYA plans two IDE849 Phase 3 trials by year end and expects initial global Phase 1/2 data by the end of 2026 or early 2027.
IDEAYA Biosciences (NASDAQ: IDYA) granted stock options covering 99,600 shares to newly hired employees on October 29, 2026.
The awards were made under its 2023 Employment Inducement Incentive Award Plan. The exercise price is $32.89 per share, equal to the grant-date closing stock price. The options have a 10-year term and vest over four years, subject to continued service on each vesting date.
IDEAYA Biosciences (IDYA) announced updated Phase 1 results for IDE849, including preliminary median overall survival of 17.4 months in second-line small cell lung cancer. Partner Hengrui's China study enrolled 122 patients. In second-line disease, confirmed response was 60.8% and median progression-free survival, the time without disease worsening, was 6.9 months. Across previously treated small cell lung cancer, median overall survival was 14.7 months. Among 19 patients with other neuroendocrine carcinomas, confirmed response was 36.8%.
At the 2.4 mg/kg expansion dose, severe treatment-related adverse events occurred in 33.3%; one treatment-related death occurred across the study. IDEAYA targets two global Phase 3 trials following FDA meetings. A separate global study is evaluating doses, with an efficacy and safety update targeted by the end of 2026 or early in 2027.
IDEAYA Biosciences (Nasdaq: IDYA) announced updated darovasertib results from three ongoing clinical trials in metastatic and primary uveal melanoma.
In OptimUM-01, darovasertib plus crizotinib produced median progression-free survival, or time without disease worsening, of 7.4 months in 13 treatment-naïve HLA-A*02:01-positive patients; median overall survival was 27.1 months. OptimUM-02 subgroup analyses showed improved response rates and progression-free survival versus investigator-selected therapy in first-line HLA-A*02:01-negative disease.
In OptimUM-09, darovasertib before local treatment yielded 57% eye preservation in patients requiring eye removal; 66% of the radiation-treatment cohort had reduced planned radiation doses to critical eye structures. These figures reflect the February 23, 2026 cutoff; updated June 15 data will be presented at ESMO. Treatment-related adverse events caused discontinuations in OptimUM-01.
IDEAYA Biosciences (IDYA) promoted Dr. Michael White from chief scientific officer to president of research and development, effective September 28, 2026. White had served as chief scientific officer since 2021. The company’s oncology pipeline targets solid tumors, including uveal melanoma, pancreatic cancer and lung cancer.
IDEAYA Biosciences (IDYA) granted stock options covering 94,000 shares to three newly hired employees on September 24, 2026. The options have a $36.74 exercise price, equal to the stock’s closing price on the grant date, and a 10-year term. Granted under the 2023 Employment Inducement Incentive Award Plan, they vest over four years, subject to continued service.
IDEAYA Biosciences (IDYA) and Servier have dosed the first patient in OptimUM-11, a global Phase 3 registrational trial of oral darovasertib plus crizotinib as adjuvant therapy for patients with primary uveal melanoma at increased risk of metastasis after completing local treatment.
The study will enroll approximately 450 patients worldwide, randomized 1:1 to receive the combination therapy for 12 months or observation. The trial’s primary endpoint is relapse-free survival. OptimUM-11 targets a setting where there are currently no approved adjuvant treatments for primary uveal melanoma, aiming to reduce the risk of metastatic recurrence.
IDEAYA Biosciences (NASDAQ: IDYA) announced an Investor R&D Day in London on Monday, November 16, 2026, at 5:00 PM GMT, focused on MTAP/CDKN2A and KRAS development strategies in pancreatic cancer, including new preclinical data and combination approaches. The event will feature Dr. Frank McCormick of UCSF and requires advance registration for in-person and virtual attendance. IDEAYA will also participate in several major September 2026 healthcare and biopharma investor conferences in Boston and New York, with multiple fireside chats involving senior management and webcast access via the company’s investor website.
IDEAYA Biosciences (NASDAQ: IDYA) reported a successful FDA Type C meeting that informed the planned design of a global randomized Phase 3 registrational trial of IDE849, a DLL3-targeting TOP1 antibody-drug conjugate, in extensive stage small cell lung cancer (ES‑SCLC) with prior tarlatamab treatment.
IDEAYA is targeting Phase 3 initiation by year-end 2026, enrolling ~400 ES‑SCLC patients randomized 1:1 to IDE849 monotherapy versus investigator’s choice (topotecan or amrubicin). The primary endpoint for potential accelerated approval will be ORR by blinded independent central review; median overall survival will serve as the primary endpoint for potential full approval.
Ongoing Phase 1 work is evaluating 2.4 mg/kg and 3.5 mg/kg IV Q3W to select the recommended Phase 3 dose. IDE849 is also being studied in combinations with AstraZeneca’s Imfinzi and IDEAYA’s PARG inhibitor IDE161 to inform a potential first‑line SCLC Phase 3 trial design.