Ideaya Biosciences - IDYA STOCK NEWS

IDEAYA Biosciences (NASDAQ: IDYA) has received FDA Breakthrough Therapy Designation (BTD) for darovasertib, a first-in-class protein kinase C inhibitor, for neoadjuvant treatment of adult patients with primary uveal melanoma (UM) recommended for enucleation.

The BTD application was supported by Phase 2 clinical data showing 82% ocular tumor shrinkage rate and 61% eye preservation rate in UM patients. The company plans to initiate a Phase 3 registrational study in neoadjuvant UM in H1 2025.

Neoadjuvant UM represents a significant market opportunity with approximately 12,000 annual patients across North America, Europe, and Australia, with no FDA-approved systemic therapies currently available. The company plans to present updated clinical data, including efficacy, safety, and vision preservation metrics, at medical conferences in mid-2025 and H2 2025.

IDEAYA Biosciences (NASDAQ: IDYA) has announced the granting of inducement stock options to a new employee on March 27, 2025. The Compensation Committee approved non-qualified stock options to purchase 17,600 shares of common stock under the company's 2023 Employment Inducement Incentive Award Plan.

The stock options were granted at an exercise price of $17.43 per share, matching the closing price of IDEAYA's stock on the Nasdaq Global Select Market on the grant date. These options have a 10-year term and will vest over four years, with 25% vesting after the first year and the remaining 75% vesting in monthly installments over the following three years, contingent on continued employment.

IDEAYA Biosciences (Nasdaq: IDYA) announced multiple presentations at AACR 2025, featuring IDE275 (GSK959), their Phase 1 Werner Helicase inhibitor. The drug, developed in partnership with GSK, will be highlighted in an oral presentation and three poster presentations.

IDE275 has shown potential as a best-in-class WRN inhibitor for treating MSI-H solid tumors, demonstrating selective preclinical efficacy. The drug targets significant patient populations, with MSI-H prevalence reported at approximately 31% in endometrial, 20% in colorectal, and 19% in gastric cancers.

Under the collaboration terms, GSK holds exclusive global rights and covers 80% of R&D costs, while IDEAYA maintains 20%. IDEAYA could receive a $10M milestone payment upon Phase 1 expansion, up to $465M in development milestones, and up to $475M in commercial milestones, plus 50% of U.S. net profits and tiered royalties on global non-U.S. sales.

IDEAYA Biosciences (NASDAQ: IDYA) has announced a research collaboration with ATTMOS to enhance its drug discovery capabilities for first-in-class oncology targets. The partnership aims to develop a physics-based computational platform for small molecule discovery, focusing on targets currently considered undruggable.

The collaboration will combine IDEAYA's expertise in structural biology and pharmaceutical drug discovery with ATTMOS's capabilities in computational chemistry, high-performance computing, and software development. The primary goal is to create a workflow solution for high-throughput absolute binding free energy perturbation predictions (ABFEP) of drug candidate molecules.

The initiative will utilize the Amber molecular dynamics suite for GPU-accelerated free energy simulations. IDEAYA will leverage its wet-lab drug discovery campaign data to train and evaluate ABFEP-based active learning cycles, enabling efficient screening of chemical libraries for novel small molecule ligands.

IDEAYA Biosciences (NASDAQ: IDYA) has announced the granting of non-qualified stock options to four newly hired employees through its 2023 Employment Inducement Incentive Award Plan. The Compensation Committee approved options to purchase 125,600 shares of common stock on February 27, 2025.

The stock options were granted at an exercise price of $20.24 per share, matching the closing price of IDEAYA's stock on the Nasdaq Global Select Market on the grant date. These options come with a 10-year term and follow a four-year vesting schedule: 25% vesting after the first year, with the remaining 75% vesting in equal monthly installments over the following three years. The vesting is contingent upon continued employment with IDEAYA.

IDEAYA Biosciences reported its Q4 and full-year 2024 financial results, highlighting significant progress across its clinical pipeline. The company ended 2024 with approximately $1.1 billion in cash, cash equivalents, and marketable securities, expected to fund operations into at least 2028.

Key developments include over 230 patients enrolled in the registration-enabling trial for darovasertib in metastatic uveal melanoma, with median PFS readout targeted by year-end 2025. The company reported encouraging Phase 1 expansion results for IDE397 in MTAP-deletion cancers and selected clinical expansion doses for DLL3 TOP1i ADC IDE849.

Financial highlights for Q4 2024 include collaboration revenue of $7.0 million, R&D expenses of $140.2 million, and a net loss of $130.3 million. The full-year 2024 net loss was $274.5 million.

IDEAYA Biosciences (IDYA) has expanded its clinical collaboration with Gilead Sciences to evaluate IDE397, a potential first-in-class MAT2A inhibitor, in combination with Gilead's Trodelvy in MTAP-deletion non-small cell lung cancer (NSCLC). The combination targets two distinct mechanisms in MTAP-deletion solid tumors, with MTAP-deletion occurring in approximately 15% of NSCLC cases, representing a significant portion of the estimated 48,000 U.S. cases annually.

The study will expand the ongoing Phase 1 trial, which currently evaluates the combination in MTAP-deletion urothelial cancer. Under the agreement, both companies retain commercial rights to their respective compounds. IDEAYA will sponsor the study while Gilead provides Trodelvy supply. The company expects to provide clinical program updates in 2025.

IDEAYA Biosciences (NASDAQ: IDYA) has appointed Joshua Bleharski, Ph.D. as Chief Financial Officer, expected to transition into the role by early May. Dr. Bleharski joins from J.P. Morgan, where he served as Managing Director and Global Co-Head of Biopharma in the Healthcare Investment Banking group for nearly 17 years.

During his tenure at J.P. Morgan, Dr. Bleharski advised on financing and strategic transactions exceeding $65 billion in value for biotechnology companies. The company currently has 6 potential first-in-class clinical programs and 3 preclinical programs in development across multiple solid tumor indications.

Dr. Bleharski's background includes positions as Senior Staff Scientist at a private biotechnology company and post-doctoral fellowships at LIAI and UCLA School of Medicine. He holds a BS in Biology from Duke University, a Ph.D. in Immunology from UCLA, and an MBA from UC Berkeley's Haas School of Business.

IDEAYA Biosciences (NASDAQ: IDYA) has announced the grant of non-qualified stock options to two newly hired employees. The Compensation Committee approved options to purchase 62,800 shares of common stock on January 30, 2025, under the company's 2023 Employment Inducement Incentive Award Plan.

The stock options were granted at an exercise price of $23.88 per share, matching IDEAYA's closing price on The Nasdaq Global Select Market on the grant date. These options have a 10-year term and will vest over four years, with 25% vesting after the first year and the remaining 75% vesting monthly over the following three years, subject to continued employment.