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IDEAYA Biosciences, Inc. (NASDAQ: IDYA) is an innovative biotechnology firm concentrated on oncology. Established in 2015 and headquartered in South San Francisco and La Jolla, California, the company is dedicated to the discovery and development of precision medicine therapies for genetically defined patient groups. Their focus areas include synthetic lethality and immuno-oncology, targeting DNA damage repair mechanisms and the tumor microenvironment, respectively.
IDEAYA's pioneering approach leverages molecular diagnostics to identify and develop targeted therapeutics. The company's leading product candidate, IDE196, is a potent inhibitor of protein kinase C (PKC), aimed at treating cancers with GNAQ or GNA11 mutations. In addition, IDEAYA is advancing several clinical programs, such as the darovasertib program, which is currently in Phase 2 trials for uveal melanoma (UM) and has shown promising results in tumor shrinkage and eye preservation.
In synthetic lethality, IDEAYA's IDE397 targets methionine adenosyltransferase 2 alpha (MAT2A) in solid tumors with MTAP deletion, a condition prevalent in 15% of solid tumors. The IDE397 program includes both monotherapy and combination trials with other investigational drugs.
Financially, IDEAYA is robust with cash reserves exceeding $941.4 million as of Q1 2024, ensuring operational funding through 2028. Key investors include 5AM Ventures, Canaan Partners, and Celgene. The company has formed strategic collaborations with major pharmaceutical players like Pfizer, Amgen, Gilead Sciences, GSK, and Merck to amplify its research and clinical capabilities.
IDEAYA's scientific advisory board is composed of esteemed researchers, including a Nobel laureate and members of the National Academy of Sciences, underscoring the company's commitment to groundbreaking research.
Recent developments are promising: IDEAYA reported favorable Phase 2 trial results for IDE196 in UM, with significant tumor reduction and eye preservation rates. Additionally, a collaboration with Merck for the IDE161 program aims to tackle endometrial cancer using advanced immunotherapy combinations.
For more detailed updates and financial information, visit IDEAYA's Investor Relations page.
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.
IDEAYA Biosciences (Nasdaq:IDYA) reported a strong financial position with approximately $346 million in cash and equivalents as of March 31, 2022, expected to support operations into 2025. The company is advancing several clinical trials, including the IDE397 Phase 1/2 study and updates on darovasertib combination therapies. Collaboration revenue reached $11.4 million in Q1 2022, up from $3.0 million in Q4 2021. However, net losses were $14.0 million, showing a decrease from $18.2 million the previous quarter.
IDEAYA Biosciences (NASDAQ: IDYA) announced its participation in key investor conferences in May 2022. Scheduled events include the JP Morgan Conference on May 16, featuring a fireside chat with CEO Yujiro Hata, and the Guggenheim Synthetic Lethality Day, also on May 16, where Hata will participate in panel discussions. The Citi Biopharma Virtual Co-Panel Day is set for May 18. Interested parties can access live audio webcasts and replays on IDEAYA's website. IDEAYA specializes in synthetic lethality-focused precision medicine for targeted cancer therapeutics.
IDEAYA Biosciences (NASDAQ: IDYA) announced that the FDA has granted orphan-drug designation to darovasertib, a potential first-in-class PKC inhibitor, for treating uveal melanoma. This designation provides IDEAYA with tax credits, user fee exemptions, and seven years of marketing exclusivity post-approval. IDEAYA plans to update clinical data related to the darovasertib and crizotinib combination in mid-2022 and seeks FDA guidance for a registration-enabling trial design. Over 200 patients have been evaluated, with ongoing trials targeting additional oncology indications.
IDEAYA Biosciences has announced the appointment of Dr. Catherine Mackey to its Board of Directors. With over 30 years of experience in life sciences, Dr. Mackey previously held senior roles at Pfizer and has an extensive background in oncology research and development. Her expertise is expected to enhance IDEAYA's synthetic lethality platform and support the advancement of its drug pipeline, particularly the Phase 1 MAT2A inhibitor IDE397 and Phase 2 PKC inhibitor darovasertib. This strategic addition aims to drive progress in the company’s targeted therapeutics initiatives.
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