IDYA - Earnings announcements

Trial met the primary endpoint showing statistically significant improvement in median PFS by BICR, with 6.9 months for the darovasertib combination versus 3.1 months for ICT (HR: 0.42; 95% CI: 0.30, 0.59; p-value: <0.0001)Secondary endpoint of ORR by BICR was 37.1% for the darovasertib combination versus 5.8% for ICT (p-value: <0.0001), including 5 complete responses in the darovasertib combination armDarovasertib combination showed an early trend in improvement for OS versus ICTWell-tolerated, with manageable safety profile consistent with previously reported AEsNDA submission planned for H2'26 to support U.S. accelerated approval filing. Full data from OptimUM-02 to be presented at major

SOUTH SAN FRANCISCO, Calif., April 10, 2026 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), a precision medicine oncology company, today announced plans to issue a joint IDEAYA and Servier pre-market press release and host a conference call and webcast on Monday, April 13, 2026 at 8:00 a.m. ET to disclose topline results from their ongoing Phase 2/3 registrational trial, OptimUM-02, evaluating darovasertib in combination with crizotinib in patients with first-line HLA*A2-negative metastatic uveal melanoma. The call will include members of IDEAYA's management joined by a distinguished key opinion leader.

Phase 2 company-sponsored and IST neoadjuvant uveal melanoma (UM) clinical data update in 49 evaluable patients, demonstrates ~49% of patients with >30% tumor shrinkage by product of diameters, and ~61% eye preservation rate for enucleation patientsTargeting to initiate Phase 3 randomized registrational trial in neoadjuvant UM following finalization of the clinical protocol with FDAClinical endpoints supportive of full approval based on FDA guidance: Eye preservation rate as the primary endpoint for enucleation patients. Time to vision loss as the primary endpoint for plaque brachytherapy patients. No detriment to Event-Free-Survival (EFS) in the treatment arms is a secondary endpointDiscuss

SOUTH SAN FRANCISCO, Calif., Sept. 22, 2024 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, today announced that the company plans to issue a pre-market press release and conduct an investor webcast on Monday, September 23, 2024, at 8:00 a.m. ET to report interim Phase 2 data for darovasertib and provide a regulatory update from FDA Type C meeting in neoadjuvant uveal melanoma (UM). Darovasertib is a potent and selective protein kinase C (PKC) inhibitor being developed to broadly address primary and metastatic UM.

~39% Overall Response Rate (ORR): 1 CR and 6 PRs (2 awaiting confirmation) by RECIST 1.1 out of 18 evaluable MTAP-deletion urothelial and NSCLC patients~94% Disease Control Rate (DCR): 1 CR and 6 PRs and 10 SD by RECIST 1.1~78% of Patients with Tumor Shrinkage: 14 patients observed tumor shrinkage~81% ctDNA Molecular Response Rate (MRR): 13 of 16 patients with > 50% ctDNA reductionAE Profile: ~5.6% drug-related grade >3 AEs and no drug-related SAEs or discontinuations at 30 mg once-a-day expansion doseIDE397 expansion dose of 30 mg once-a-day achieved target drug coverage and plasma SAM pharmacodynamic reduction associated with preclinical tumor regressions~48k U.S. annual incidence of MTAP-

Confirmed overall response rate (ORR) of 45%, disease control rate (DCR) of 90% and median PFS of ~7 months in 20 evaluable First-Line MUM patientsBased on FDA meeting, initiating Phase 2/3 registrational trial in Q2 2023 in First-Line HLA-A2 negative MUM, with median PFS as primary endpoint for potential accelerated approvalConfirmed overall response rate (ORR) of 30%, disease control rate (DCR) of 87% and median PFS of ~7 months in 63 evaluable Any-Line MUM patientsConfirmed overall response rate (ORR) of 35%, disease control rate (DCR) of 100% and median PFS of ~11 months in 20 evaluable Hepatic-Only MUM patientsHistorical % ORR and median PFS by other therapies in MUM have been low, rang

Confirmed partial responses by RECIST observed in 4 of 8 (50% ORR) evaluable First-Line MUM patients and in 11 of 35 (31% ORR) evaluable Any-Line MUM patientsTumor shrinkage observed in 31 of 35 (89%) Any-Line MUM patientsMedian PFS not yet reached and >5 months in evaluable First-Line MUM patients; observed median PFS of ~5 months in evaluable Any-Line MUM patientsHistorical % ORR and median PFS by other therapies in MUM have been low, ranging from ~0% to 5% ORR and ~2 to 3 months median PFSProof-of-concept for use in (neo)adjuvant UM with tumor shrinkage in 5 of 5 ocular lesions, including reductions of ~-74% and -67%, each with improved visual symptomsTotal UM and MUM annual incidence in

SAN FRANCISCO, May 3, 2022 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced its participation in investor conferences in May 2022. 2022 JP Morgan Conference Call SeriesMonday, May 16 at 10:00am ETFireside chat with Yujiro Hata, Chief Executive Officer, IDEAYA Biosciences, hosted by Anupam Rama, Managing Director US SMID Biotechnology Equity Research Virtual Guggenheim Synthetic Lethality Day Monday, May 16 at 12:00pm ETFireside

Observed preclinical complete suppression (~95-100%) of tumor SDMA in multiple MTAP-deleted patient derived xenograft (PDX) models across indications Interim IDE397 clinical data demonstrates robust plasma pharmacodynamic modulation, exceeding target of >60% reduction of plasma SAM across all evaluated cohorts Observed clinical exposure-dependent reduction of tumor pharmacodynamic biomarker SDMA in target tumor types, including 95% reduction of tumor SDMA No drug-related Serious Adverse Events (SAEs) observed through Cohort 5 Enrolling into Cohort 6 of the dose escalation Phase 1 evaluating IDE397; have not yet determined the maximum tolerated dose (MTD) through Cohort 5 Targeting initiation

SOUTH SAN FRANCISCO, Calif., March 8, 2022 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced plans to issue a pre-market press release and host an Investor Webcast on Tuesday, March 15, 2022 to discuss interim clinical data for IDE397, a potential best-in-class MAT2A inhibitor being evaluated in a Phase 1 Clinical Trial (NCT 04794699) in patients having tumors with MTAP deletion.  IDEAYA will host a conference call and webcast

SOUTH SAN FRANCISCO, Calif., Dec. 7, 2021 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, provided a clinical data update for the Phase 1/2 trial evaluating darovasertib and crizotinib synthetic lethal combination in metastatic uveal melanoma (MUM) patients. "The partial responses, percentage of patients with tumor shrinkage and disease control rate observed from the darovasertib and crizotinib synthetic lethal combination in heavily pr

SOUTH SAN FRANCISCO, Calif., Nov. 29, 2021 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced its plans for a clinical data update on December 7, 2021, including plans to issue a pre-market press release and host a conference call and webcast to discuss clinical data from the ongoing Phase 1/2 trial evaluating darovasertib and crizotinib combination in patients with metastatic uveal melanoma (MUM) (ClinicalTrials.gov Identifier: NCT03947385).