Ideaya Biosciences Stock Price, News & Analysis

IDEAYA Biosciences (IDYA) announced interim results from its Phase 2 clinical trial of darovasertib and crizotinib in metastatic uveal melanoma (MUM). The trial showed a **50% overall response rate** (ORR) in first-line MUM patients and an **89% tumor shrinkage** rate in any-line MUM patients. The observed median progression-free survival (PFS) was over **5 months** in first-line MUM patients. No FDA-approved therapies exist for GNAQ and GNA11 solid tumors, indicating a high unmet medical need. IDEAYA plans to initiate a registration-enabling trial in Q1 2023.

IDEAYA Biosciences has initiated an Investigator Sponsored Trial (IST) in Australia to evaluate darovasertib as a monotherapy for primary, non-metastatic uveal melanoma (UM). Preliminary signs of clinical activity show tumor shrinkage in patients following treatment. With an annual incidence of about 8,700 patients in the US and EU, (neo)adjuvant UM represents an unmet medical need. The trial aims to assess the feasibility and tolerability of darovasertib, following anecdotal evidence of effectiveness. Clinical proof-of-concept data is expected in September 2022.

IDEAYA Biosciences (NASDAQ: IDYA) announced its participation in several key investor conferences in September 2022. These include Citi's 17th Annual BioPharma Conference (Sept 7-8), Wells Fargo Healthcare Conference (Sept 7-9), Morgan Stanley's Global Healthcare Conference (Sept 12-14), Baird's Global Healthcare Conference (Sept 13-14), Oppenheimer's Oncology Summit (Sept 21), and Cantor's HemOnc Conference (Sept 28). Notable presentations will feature CEO Yujiro Hata and CFO Paul Stone. Live audio webcasts will be accessible on IDEAYA's website.

IDEAYA Biosciences has achieved a preclinical development milestone for its Pol Theta Helicase Inhibitor DC in collaboration with GSK, facilitating IND-enabling studies. The company anticipates potential preclinical and clinical milestone payments up to $20 million, including $10 million for IND effectiveness. Targeting first-in-human trials in H1 2023, IDEAYA aims for IND submission to advance this potential first-in-class therapy for patients with HR mutations. IDEAYA can benefit from up to $485 million in total milestones, plus commercial royalties.

IDEAYA Biosciences (IDYA) announced its Q2 2022 financial results, reporting a cash position of $324 million anticipated to fund operations into 2025. The company initiated Phase 2 expansion of IDE397 and entered a collaboration with Amgen for clinical trials in MTAP-null solid tumors. Despite a net loss of $22.1 million for Q2 2022, IDEAYA's pipeline shows promise with expected clinical data updates in September 2022 and IND submissions planned for Q4 2022.

IDEAYA Biosciences announced updates for IDE397, a MAT2A inhibitor, in a Phase 1/2 trial. Enrollment is ongoing for monotherapy cohorts in NSCLC and esophagogastric tumors with MTAP deletion. Combination cohorts with taxanes and potential first-in-class combinations like pemetrexed have begun. A collaboration with Amgen for evaluating IDE397 with AMG 193 was established. Promising ctDNA molecular responses were noted, particularly in cohorts with higher doses. IDEAYA delivered an Option Data Package to GSK, marking a collaboration milestone.

IDEAYA Biosciences announced a clinical trial collaboration with Amgen to evaluate IDE397, a MAT2A inhibitor, in combination with Amgen's AMG 193, targeting MTAP-null solid tumors. This partnership aims to explore the efficacy of this first-in-class synthetic lethality combination, expected to impact approximately 15% of solid tumors. Amgen will sponsor the Phase 1 trial, sharing costs with IDEAYA, while both companies retain commercial rights to their respective therapies. IDEAYA continues its ongoing Phase 1/2 trial for IDE397, evaluating it in various cancer settings.

IDEAYA Biosciences (Nasdaq: IDYA) has selected a potential first-in-class Pol Theta Helicase development candidate in collaboration with GSK. Preclinical studies show complete responses with Niraparib in various PDX and CDX HRD models, with the aim for first-in-human evaluation in H1 2023. IDEAYA is eligible for up to $960 million in total milestones from GSK, including $485 million for development and regulatory achievements, along with $475 million in commercial sales milestones. GSK will lead clinical development while covering research and development costs.

IDEAYA Biosciences (NASDAQ: IDYA) announced its participation in the 2022 Jefferies Global Healthcare Conference on June 8, 2022, at 11:00 AM ET. CEO Yujiro Hata will engage in a fireside chat hosted by equity research analyst Maury Raycroft. A live audio webcast will be available on IDEAYA's website, with a replay accessible for 30 days post-event. IDEAYA focuses on precision medicine in oncology, targeting specific patient populations through molecular diagnostics and synthetic lethality.