Ideaya Biosciences Stock Price, News & Analysis

IDEAYA Biosciences (Nasdaq: IDYA) announced positive interim Phase 2 data for darovasertib in treating primary uveal melanoma (UM). The drug showed impressive results in the neoadjuvant setting, with 76% of patients achieving ≥20% ocular tumor shrinkage. Key findings include 48% of patients achieving ≥20% reduction in simulated radiation dose to key visual structures and 65% of patients showing visual improvement during treatment.

The Phase 2 OptimUM-09 trial evaluated 39 patients for safety and 21 for efficacy. Darovasertib demonstrated a manageable safety profile with mostly Grade 1 and 2 treatment-related adverse events, though approximately 10% experienced Grade 3 or higher events. The company has initiated a Phase 3 registration-enabling OptimUM-10 trial during Q2 2025.

IDEAYA Biosciences (NASDAQ:IDYA) and Hengrui Pharma presented positive Phase 1 data for IDE849, a potential first-in-class DLL3 TOP1 ADC for Small Cell Lung Cancer (SCLC) at WCLC 2025. The study showed impressive efficacy with a 77.1% overall response rate (ORR) in second-line SCLC patients and 73.2% ORR across all treatment lines at expansion doses.

Key highlights include a 6.7-month median progression-free survival across all lines, with median PFS not yet reached in second-line patients. The drug demonstrated particular efficacy in patients with brain metastases, achieving an 83.3% confirmed ORR at the 2.4 mg/kg dose. The safety profile was manageable, with a low 2% treatment-related discontinuation rate.

IDEAYA Biosciences (NASDAQ:IDYA) has announced the enrollment of its first non-small cell lung cancer (NSCLC) patient in the Phase 1/2 combination trial of IDE397 and Trodelvy®. The trial, conducted in collaboration with Gilead, evaluates this novel combination in patients with MTAP-deletion solid tumors.

Following encouraging preliminary data in bladder cancer, the trial has expanded into NSCLC, where MTAP-deletion occurs in up to 20% of cases. IDE397 is being developed as a potential first-in-class MAT2A inhibitor, while Trodelvy® is an established Trop2-directed antibody-drug conjugate. Under the collaboration agreement, IDEAYA maintains study sponsorship while Gilead provides Trodelvy supply, with both companies retaining commercial rights to their respective compounds.

IDEAYA Biosciences (NASDAQ:IDYA) has submitted an Investigational New Drug (IND) application to the FDA for IDE892, a potential best-in-class MTA-cooperative PRMT5 inhibitor targeting MTAP-deletion solid tumors. The company plans to initiate a Phase 1 dose escalation trial in MTAP-deleted lung cancer in Q4 2025.

The clinical development strategy includes advancing to combination trials with IDE397, IDEAYA's proprietary MAT2A inhibitor, in H1 2026. The target market is significant, with 15-20% of non-small cell lung cancer (NSCLC) cases being MTAP-deleted. The company will also evaluate IDE892 in other MTAP solid tumor indications, both as monotherapy and in combination with IDE397.

IDEAYA Biosciences (NASDAQ: IDYA) has entered into an exclusive license agreement with Servier for darovasertib, a potential first-in-class treatment for uveal melanoma, a rare and aggressive eye cancer. Under the agreement, IDEAYA will receive $210 million upfront and up to $320 million in milestone payments, plus double-digit royalties on net sales.

The partnership grants Servier regulatory and commercial rights for darovasertib outside the United States, while IDEAYA retains U.S. rights. The drug, which has received FDA Breakthrough Therapy and Fast Track designations, is being evaluated in multiple global clinical trials, including three Phase 3 registrational trials targeting neoadjuvant, adjuvant, and metastatic settings.

IDEAYA Biosciences (NASDAQ:IDYA) announced the acceptance of an abstract for oral presentation at the 2025 Society for Melanoma Research Congress in Amsterdam. The presentation will feature the first-ever median overall survival data from their Phase 1/2 trial evaluating the combination of darovasertib and crizotinib in first-line metastatic uveal melanoma (mUM).

The study, known as OptimUM-01, includes data from over 40 patients. Dr. Meredith McKean from Sarah Cannon Research Institute will present the findings at the congress, which takes place from October 25-28, 2025. The detailed data from the abstract will be disclosed at a future date.

IDEAYA Biosciences (NASDAQ: IDYA) announced the granting of inducement stock options to four newly hired employees on August 28, 2025. The Compensation Committee approved non-qualified stock options to purchase 139,800 shares of common stock under the company's 2023 Employment Inducement Incentive Award Plan.

The stock options have an exercise price of $24.93 per share, matching IDEAYA's closing price on the grant date. The options feature a 10-year term with a four-year vesting schedule: 25% vesting after one year and the remaining 75% vesting monthly over three years, contingent on continued employment.

IDEAYA Biosciences (NASDAQ: IDYA), a precision medicine oncology company, has announced its participation in three major investor events in September 2025. The company will participate in a fireside chat at the Cantor Global Healthcare Conference on September 3rd, host its 10-Year Anniversary R&D Day on September 8th featuring clinical data updates and KOL Dr. Arun D. Singh, and attend the Morgan Stanley Global Healthcare Conference on September 9th for one-on-one meetings.

The R&D Day will showcase multiple clinical data updates, outline future catalysts, and review long-term portfolio strategy. Live audio webcasts will be available on the company's investor relations website, with replays accessible for 30 days post-event.

IDEAYA Biosciences (NASDAQ:IDYA) will host its 10-Year Anniversary R&D Day on September 8, 2025 in New York from 8:00-10:30am EST. The event will showcase the company's progress and future growth strategy, featuring presentations on multiple clinical programs.

Key highlights include new clinical data presentations on darovasertib in neoadjuvant uveal melanoma, IDE849 (DLL3 TOP1 ADC), and IDE397 (MAT2A). Dr. Arun D. Singh from Cleveland Clinic will present Phase 2 trial data of darovasertib and discuss the Phase 3 OptimUM-10 trial design. The agenda also covers IDE892 (PRMT5) development and the company's AI/ML discovery capabilities.