Ideaya Biosciences Inc

IDEAYA Biosciences, Inc. engages in the research and development of oncology-focused precision medicine. The firm focuses on the targeted therapeutics for patients selected using molecular diagnostics. Its product candidate, IDE196, is a protein kinase C inhibitor for genetically-defined cancers having GNAQ or GNA11 gene mutations. The company was founded by Yujiro S. Hata and Jeffrey Hager in June 2015 and is headquartered in South San Francisco, CA.

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IDEAYA Biosciences, Inc. engages in the research and development of oncology-focused precision medicine. The firm focuses on the targeted therapeutics for patients selected using molecular diagnostics. Its product candidate, IDE196, is a protein kinase C inhibitor for genetically defined cancers having GNAQ or GNA11 gene mutations. The company was founded by Yujiro S. Hata and Jeffrey Hager in June 2015 and is headquartered in South San Francisco, CA.

SOUTH SAN FRANCISCO, Calif. , Feb. 1, 2023 /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 the 2023 Guggenheim Oncology Conference.

IDEAYA Biosciences to Participate in the 2023 Guggenheim Oncology Conference

-  Initiated Phase 2 clinical trial evaluating Darovasertib as neoadjuvant treatment of uveal melanoma prior to primary interventional treatment of enucleation or radiation therapy -  Clinical protocol includes neoadjuvant treatment with Darovasertib to maximum benefit up to 6 months, primary treatment, then up to 6 months of follow-up adjuvant therapy -  Neoadjuvant endpoints include eye preservation, reducing radiation and vision preservation; adjuvant endpoints include relapse free survival and useful vision -  UM represents an unmet medical need and potential clinical expansion opportunity with annual incidence of approximately 8,700 patients in the US and EU -  Targeting clinical data update for Darovasertib / Crizotinib Combination in MUM in 2023, including overall survival (OS) data SOUTH SAN FRANCISCO, Calif. , Jan. 23, 2023 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced that it has initiated enrollment into a company-sponsored Phase 2 clinical trial to evaluate darovasertib as monotherapy in neo-adjuvant and adjuvant settings in primary, non-metastatic uveal melanoma (UM) patients.

IDEAYA Announces Darovasertib Phase 2 Initiation in Neoadjuvant and Adjuvant Uveal Melanoma and Guidance for Clinical Data Update in Metastatic Uveal Melanoma

- Targeting to initiate dosing of Phase 1 clinical trial in Q1 2023 to evaluate IDE161 in patients having tumors with HRD, including BRCA1/2-mutant breast and ovarian cancer - Starting dose of IDE161 in the Phase 1 dose escalation is one-half of the projected human efficacious dose, based on preclinical studies - IDE161 monotherapy clinical focus includes ER+ / Her2- breast cancer with HRD, representing approximately 10% to 14% of breast cancer - IDE161 preclinical profile and clinical development plans to be highlighted by IDEAYA at J.P. Morgan Healthcare Conference on Tuesday, January 10 th, 2023, at 4:30 pm PT SOUTH SAN FRANCISCO, Calif.

IDEAYA Announces IND Clearance by U.S. FDA enabling Phase 1 Initiation for First-in-Class PARG Development Candidate IDE161

SOUTH SAN FRANCISCO, Calif. , Jan. 3, 2023 /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 at the 41st Annual J.P.

IDEAYA Biosciences to Present at the 41st Annual J.P. Morgan Healthcare Conference on Tuesday, January 10, 2023

-    Dr. Karlene Cimprich, Ph.D. (Stanford University), is a leading scientist in replication stress mechanisms and regulation of DNA Damage Repair pathways -    Dr. Kornelia Polyak, M.D.

IDEAYA Biosciences Appoints Dr. Karlene Cimprich, Ph.D. and Dr. Kornelia Polyak, M.D.

-   IDE161 is being developed as a potential first-in-class PARG inhibitor for patients having tumors with HRD, with an initial focus in BRCA1/2-mutant Breast and Ovarian Cancer -   Proposed clinical development plan for IDE161 to be highlighted in Investor R&D Day webcast being hosted by IDEAYA today, December 12, 2022, at 8:00 am ET SOUTH SAN FRANCISCO, Calif. , Dec. 12, 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 it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for initiation of a Phase 1/2 clinical trial to evaluate IDE161, a small molecule inhibitor of poly (ADP-ribose) glycohydrolase (PARG), for the treatment of patients having solid tumors with homologous recombination deficiency (HRD).

IDEAYA Biosciences Announces Submission of IND Application to the U.S. FDA for PARG Development Candidate IDE161

The average of price targets set by Wall Street analysts indicates a potential upside of 34.2% in IDEAYA Biosciences, Inc. (IDYA). While the effectiveness of this highly sought-after metric is questionable, the positive trend in earnings estimate revisions might translate into an upside in the stock.

Wall Street Analysts Believe IDEAYA Biosciences, Inc. (IDYA) Could Rally 34%: Here's is How to Trade

Fast Track designation granted by U.S. FDA for evaluation of darovasertib in combination with crizotinib in adult patients being treated for metastatic uveal melanoma (MUM) Enables darovasertib / crizotinib development program to access expedited regulatory review processes, including potential eligibility for accelerated approval / priority review SOUTH SAN FRANCISCO, Calif. , Dec. 5, 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 that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to IDEAYA's development program investigating darovasertib, a potential first-in-class protein kinase C (PKC) inhibitor, for use in combination with crizotinib, an investigational cMET inhibitor, for the treatment of adult patients with metastatic uveal melanoma.

IDEAYA Biosciences Receives Fast Track Designation for Darovasertib Combination Therapy with Crizotinib for the Treatment of Metastatic Uveal Melanoma

SOUTH SAN FRANCISCO, Calif. , Nov. 29, 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 agenda topics and participating key opinion leaders for its Investor R&D Day.

IDEAYA Biosciences Announces Agenda Topics and Key Opinion Leader Presenters for Investor R&D Day Webcast on Monday, December 12, 2022

Former Senior Vice President and Head of Early Oncology Development and Clinical Research at Pfizer will lead IDEAYA's clinical development efforts as Chief Medical Officer Over twenty-five years of experience in clinical development and translational research, including at leading pharmaceutical companies and major research institutions SOUTH SAN FRANCISCO, Calif. , Nov. 28, 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 that Darrin M.

IDEAYA Biosciences Appoints Darrin M. Beaupre, M.D.

The mean of analysts' price targets for IDEAYA Biosciences, Inc. (IDYA) points to a 31.6% upside in the stock. While this highly sought-after metric has not proven reasonably effective, strong agreement among analysts in raising earnings estimates does indicate an upside in the stock.

Wall Street Analysts Think IDEAYA Biosciences, Inc. (IDYA) Could Surge 32%: Read This Before Placing a Bet

IDEAYA Biosciences, Inc. (IDYA) delivered earnings and revenue surprises of 106.15% and 271.24%, respectively, for the quarter ended September 2022. Do the numbers hold clues to what lies ahead for the stock?

IDEAYA Biosciences, Inc. (IDYA) Q3 Earnings and Revenues Beat Estimates

Strong balance sheet of $393.9 million cash, cash equivalents and marketable securities as of September 30, 2022 is anticipated to fund planned operations into 2026 Reported Phase 2 interim clinical data for darovasertib and crizotinib combination in MUM; subject to FDA guidance, targeting initiation of potential registrational trial for Daro + Crizo in MUM in Q1 2023 Reported preliminary clinical proof-of-concept supporting potential darovasertib use in (neo)adjuvant uveal melanoma; targeting initiation of company-sponsored trial for Daro in neoadjuvant UM in Q4 2022 Initiated IDE397 Phase 2 monotherapy expansion cohorts and Phase 1 combination dose escalation cohorts with pemetrexed and taxanes in MTAP-null tumors Targeting IND filing in Q4 2022 for PARG development candidate IDE161 Targeting First-in-Human Phase 1 study initiation in H1 2023 for Pol Theta Helicase inhibitor development candidate, in collaboration with GSK, for solid tumors with HRD Hosting IDEAYA Investor R&D Day on Monday, December 12, 2022 at 8:00 am ET SOUTH SAN FRANCISCO, Calif. , Nov. 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, provided a business update and announced financial results for the third quarter ended September 30, 2022.

IDEAYA Biosciences, Inc. Reports Third Quarter 2022 Financial Results and Provides Business Update

SOUTH SAN FRANCISCO, Calif. , Nov. 1, 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 November 2022 and its plans to host an Investor R&D Day in December 2022.

IDEAYA Biosciences Announces Plans for Investor R&D Day and Participation in Upcoming Investor Conferences

First patient dosed in IDE397 combination with pemetrexed, representing a novel and potential first-in-class combination in MTAP-deletion tumors. First patient dosed in IDE397 combination with taxane in MTAP-deletion tumors

IDEAYA Announces Phase 2 MAT2A Inhibitor, IDE397, Achieves First-Patient-In for Multiple Combination Cohorts in MTAP-Deletion Tumors

Shares have posted a 40% loss over the past 12 months. I have added confidence in prospects for darovasertib in uveal melanoma given monotherapy activity as well as high ORR and PFS relative to competitors.

Ideaya Biosciences: Prospects Rebound With Updated Uveal Melanoma Data

SOUTH SAN FRANCISCO, Calif. , Sept. 19, 2022 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq:IDYA) today announced the closing of its underwritten public offering of 8,761,905 shares of its common stock at a public offering price of $10.50 per share, before underwriting discounts and commissions, including the exercise in full by the underwriters of their option to purchase up to an additional 1,142,857 shares of common stock in the offering.

IDEAYA Announces Closing of Public Offering of Common Stock and Full Exercise of Underwriters' Option to Purchase Additional Shares

SOUTH SAN FRANCISCO, Calif. , Sept. 14, 2022 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA) today announced the pricing of an underwritten public offering of 7,619,048 shares of its common stock at a public offering price of $10.50 per share, before underwriting discounts and commissions.

IDEAYA Announces Pricing of Public Offering of Common Stock

Ideaya Biosciences (IDYA) reports positive interim results from its mid-stage study, evaluating darovasertib in combination with Pfizer's Xalkori (crizotinib) in metastatic uveal melanoma. Stock up.

Ideaya (IDYA) Up on Interim Data from Mid-Stage Eye Cancer Study

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 patients Tumor shrinkage observed in 31 of 35 (89%) Any-Line MUM patients Median PFS not yet reached and >5 months in evaluable First-Line MUM patients; observed median PFS of ~5 months in evaluable Any-Line MUM patients Historical % ORR and median PFS by other therapies in MUM have been low, ranging from ~0% to 5% ORR and ~2 to 3 months median PFS Proof-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 symptoms Total UM and MUM annual incidence in US/EU28 projected at over 13,000 patients, and total UM and MUM prevalence in US/EU28 projected at over 110,000 patients Targeting to initiate potential registrational trial for Daro + Crizo in First-Line MUM in Q1 2023 and company-sponsored trial for Daro monotherapy in (neo)adjuvant UM in Q4 2022 ­Investor webcast and call scheduled for Monday, September 12, 2022, at 8:00am ET SOUTH SAN FRANCISCO, Calif. , Sept. 11, 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 interim results from its Phase 2 clinical trial evaluating darovasertib and crizotinib synthetic lethal combination in metastatic uveal melanoma (MUM) patients (ClinicalTrials.gov Identifier: NCT03947385).

IDEAYA Reports Positive Interim Phase 2 Clinical Results for Darovasertib and Crizotinib Synthetic Lethal Combination in Metastatic Uveal Melanoma

- Investigator Sponsored Trial sites in Australia include St. Vincent's Hospital, Sydney, Alfred Health, Melbourne, and the Royal Victorian Eye and Ear Hospital, Melbourne - Preliminary signals of clinical activity observed in the primary uvea, including tumor shrinkage following neoadjuvant darovasertib monotherapy treatment - (Neo)adjuvant UM represents an unmet medical need and potential clinical expansion opportunity with annual incidence of approximately 8,700 patients in the US and EU - Clinical proof-of-concept data for use in (neo)adjuvant UM setting will be presented with the interim darovasertib Phase 2 clinical data update in MUM in September 2022 SOUTH SAN FRANCISCO, Calif. , Sept. 6, 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 that it has initiated an Investigator Sponsored Trial, or IST, in coordination with St. Vincent's Hospital, Sydney, to evaluate darovasertib as monotherapy in neo-adjuvant and adjuvant settings in primary, non-metastatic uveal melanoma (UM) patients.

IDEAYA Announces First-Patient-In for Phase I Clinical Trial to Evaluate Darovasertib Monotherapy in (Neo)Adjuvant Uveal Melanoma

SOUTH SAN FRANCISCO, Calif. , Aug. 30, 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 and events in September 2022.

IDEAYA Biosciences to Participate in Investor Conferences in September 2022

Preclinical development milestone achieved in connection with ongoing IND-enabling studies to support evaluation of Pol Theta Helicase Inhibitor DC as combo with niraparib Potential to realize preclinical and clinical milestones up to $20 million total for preclinical to early Phase 1 clinical, including up to $10 million aggregate through IND effectiveness Targeting first-in-human clinical evaluation of Pol Theta Helicase Inhibitor DC in combination with niraparib in H1 2023 for patients having tumors with HRD SOUTH SAN FRANCISCO, Calif. , Aug. 29, 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 that it has achieved a preclinical development milestone in connection with ongoing IND-enabling studies for its Pol Theta Helicase Development Candidate (DC).

IDEAYA Announces Achievement of First Milestone in Ongoing Collaboration with GSK for Potential First-in-Class Pol Theta Helicase Inhibitor Development Candidate

IDEAYA Biosciences, Inc. (IDYA) delivered earnings and revenue surprises of 0% and 26.86%, respectively, for the quarter ended June 2022. Do the numbers hold clues to what lies ahead for the stock?

IDEAYA Biosciences, Inc. (IDYA) Reports Q2 Loss, Misses Revenue Estimates

Strong balance sheet of ~$324 million cash, cash equivalents and marketable securities as of June 30, 2022 is anticipated to fund planned operations into 2025 Initiated IDE397 Phase 2 monotherapy expansion cohorts and Phase 1 combination dose escalation cohorts in solid tumors with MTAP deletion Entered into Clinical Trial Collaboration and Supply Agreement with Amgen to clinically evaluate IDE397 MAT2A inhibitor in combination with AMG 193, Amgen's investigational small molecule MTA-cooperative inhibitor of PRMT5, in MTAP-null solid tumors Retained worldwide rights to IDE397, following GSK waiver of its option to an exclusive license to further develop and commercialize IDE397 Targeting interim Phase 2 clinical data update for darovasertib and crizotinib synthetic lethal combination in MUM in September 2022, including ORR, mPFS, mDOR, and AEs Tracking to submit an IND in Q4 2022 for PARG development candidate IDE161 Selected potential first-in-class Pol Theta Helicase development candidate with GSK, and targeting Phase 1 initiation in H1 2023 for solid tumors with HRD SOUTH SAN FRANCISCO, Calif. , Aug. 15, 2022 /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 business update and announced financial results for the second quarter ended June 30, 2022.

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