Welcome to our dedicated page for IDEAYA Biosciences news (Ticker: IDYA), a resource for investors and traders seeking the latest updates and insights on IDEAYA Biosciences stock.
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) completed targeted full enrollment of 435 patients in the Phase 2/3 OptimUM-02 trial of darovasertib plus crizotinib in first-line HLA*A2-negative metastatic uveal melanoma.
Topline median progression-free survival (mPFS) data are expected in 1Q 2026 to support a potential accelerated approval filing in the United States; median overall survival (mOS) will support a potential full approval once available. Prior OptimUM-01 data showed 21.1 months mOS and 7.0 months mPFS.
Darovasertib holds FDA Breakthrough Therapy, Fast Track, and Orphan Drug designations for specified uveal melanoma settings.
IDEAYA Biosciences (Nasdaq: IDYA) submitted an IND for IDE574 to the FDA on Dec 10, 2025. IDE574 is described as a potential first-in-class, equipotent, highly selective KAT6/7 dual inhibitor with reduced activity versus related KAT5/8 enzymes.
The company is targeting a Phase 1 monotherapy dose-escalation trial to begin in Q1 2026 and plans to present preclinical pharmacology and anti-tumor xenograft data for breast and lung cancer at a medical conference in 1H 2026.
Biocytogen partner IDEAYA Biosciences (Nasdaq: IDYA) received FDA IND clearance for IDE034, a bispecific B7H3/PTK7 TOP1 antibody-drug conjugate licensed from Biocytogen.
IDEAYA plans to begin patient enrollment in Q1 2026 in a Phase 1 trial targeting solid tumors (lung, colorectal, head and neck, ovarian/gynecological) that co-express B7H3 and PTK7. Preclinical data reportedly showed deep, durable tumor regressions in B7H3/PTK7-positive models. IDEAYA also plans combination evaluation with its PARG inhibitor IDE161 and expects to present supporting preclinical combination data at a major medical conference in H1 2026. Biocytogen will continue supplying source antibodies via RenBiologics and pursue further licensing opportunities.
IDEAYA Biosciences (NASDAQ: IDYA) announced FDA IND clearance for IDE034, a potential first-in-class bispecific B7H3/PTK7 TOP1 antibody-drug conjugate, clearing the way for a Phase 1 trial. The company expects to begin enrolling patients in Q1 2026, initially in solid tumors with B7H3/PTK7 expression including lung, colorectal, head and neck, and ovarian/gynecological cancers. Based on the Human Protein Atlas, B7H3/PTK7 co-expression is reported at ~30% in lung, ~46% in colorectal, and ~27% in head and neck cancers. Preclinical in vivo models showed deep, durable regressions with IDE034 monotherapy and enhanced durability when combined with IDE161 (PARG inhibitor). Additional preclinical combination data is planned for a medical conference in H1 2026.
IDEAYA Biosciences (NASDAQ: IDYA) announced on November 28, 2025 that its Compensation Committee granted non-qualified stock options on November 26, 2025 to a newly hired employee under the 2023 Inducement Plan pursuant to Nasdaq Listing Rule 5635(c)(4).
The grant totals 17,600 options with an exercise price of $35.88 per share (equal to the closing Nasdaq price on the grant date). Options carry a 10-year term and vest over four years: 25% on the first anniversary of the vesting commencement date and the remaining 75% in equal monthly installments over the following three years, subject to continued service.
IDEAYA Biosciences (NASDAQ: IDYA) announced management will participate in investor events the week of December 2, 2025.
Management appearances include a fireside chat with CEO Yujiro S. Hata at Citi's 2025 Global Healthcare Conference on Dec 2, 2025 at 9:00 AM ET and a fireside chat with CEO Yujiro S. Hata at the 8th Annual Evercore Healthcare Conference on Dec 3, 2025 at 10:50 AM ET.
A live audio webcast will be available via the IDEAYA Investors/Events webpage or through the conference host where permitted, with webcasts replayable for 30 days after the live event.
IDEAYA Biosciences (NASDAQ: IDYA) reported 3Q25 results and a business update on Nov 4, 2025. Key highlights: $1.14B cash, cash equivalents and marketable securities as of Sept 30, 2025, bolstered by a $210M upfront payment from an exclusive darovasertib license to Servier (outside U.S.) and collaboration revenue of $207.8M in 3Q25. IDEAYA expects funding into 2030.
Clinical milestones: Phase 2/3 OptimUM-02 median PFS data for darovasertib+crizotinib due by year-end 2025–1Q26; OptimUM-01 showed 21.1-month median OS and 7.0-month median PFS; IDE397 combo produced 57% ORR (4/7) in MTAP-deleted UC; IND clearance received for IDE892.
IDEAYA Biosciences (NASDAQ: IDYA) announced that on Oct 30, 2025 its Compensation Committee granted non-qualified stock options for an aggregate of 73,500 shares to two newly hired employees as inducement awards under the company's 2023 Inducement Plan in accordance with Nasdaq Listing Rule 5635(c)(4).
The options carry an exercise price of $31.60 per share (the closing price on the grant date), a 10-year term, and vest over four years (25% at the first anniversary of vesting commencement and the remaining 75% in equal monthly installments over the following three years), subject to continued service.
IDEAYA Biosciences (NASDAQ: IDYA) will participate in two investor relations events in November 2025: a Citi 2025 SMID Cap Biopharma Call Series fireside chat on Nov 6, 2025 at 12:00 PM ET, and a Jefferies Global Healthcare Conference fireside chat in London on Nov 18, 2025 at 1:00 PM GMT / 8:00 AM ET.
Both sessions feature CEO Yujiro S. Hata in discussion with industry analysts. Live audio webcasts will be available at the IDEAYA Investors/Events page and/or via the conference hosts, with replay access for 30 days where permitted.
IDEAYA Biosciences (NASDAQ: IDYA) presented positive Phase 2 data for neoadjuvant darovasertib in primary uveal melanoma at ESMO 2025 (data cut June 13, 2025).
Key results: 83% (78/94) of evaluable patients showed ocular tumor shrinkage; 57.1% eye preservation in enucleation‑recommended patients (42 completed local therapy); 95% eye preservation among patients with ≥20% tumor shrinkage. In plaque brachytherapy‑eligible patients, 70% (26/37) had reduced predicted radiation dose and 64.9% had lower predicted 3‑year vision‑loss risk. Darovasertib received FDA Breakthrough Therapy Designation for the neoadjuvant EN‑eligible setting.