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.

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.

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

Entered into Clinical Trial Collaboration and Supply Agreement with Amgen to clinically evaluate IDE397, IDEAYA's investigational MAT2A inhibitor, in combination with AMG 193, Amgen's investigational MTA-Cooperative PRMT5 inhibitor, in MTAP-null solid tumors

IDEAYA Announces Clinical Trial Collaboration with Amgen to Evaluate MAT2A-PRMT5 Synthetic Lethality Combination in MTAP Deleted Tumors

Selected a potential first-in-class Pol Theta Helicase development candidate in collaboration with GSK Observed complete responses in preclinical combination studies of Pol Theta Helicase DC with niraparib in multiple in vivo PDX and CDX HRD models Targeting first-in-human clinical evaluation of Pol Theta Helicase DC combination with niraparib in H1 2023 for patients having tumors with HRD Potential to receive up to $960 million in aggregate milestones from GSK, including up to $485 million in aggregate development and regulatory milestones and up to $475 million in aggregate commercial sales milestones SOUTH SAN FRANCISCO, Calif. , June 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 selection of a potential first-in-class Pol Theta Helicase development candidate (DC).

IDEAYA Announces Development Candidate Nomination of a Potential First-in-Class Pol Theta Helicase Inhibitor in Collaboration with GSK

The biotech bear market has been particularly hard on Precision Oncology companies - particularly those that came to market on the back of lucrative IPOs. Ideaya IPO'd in 2019, raising a modest $55m, and it continues to trade above its IPO price of $10, which is rare. Shares hit a high of $26 last September.

Ideaya: Next 6 Months Critical For Precision Oncology Biotech

SOUTH SAN FRANCISCO, Calif. , June 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 its participation at the 2022 Jefferies Global Healthcare Conference.

IDEAYA Biosciences to Present at the 2022 Jefferies Global Healthcare Conference

IDEAYA Biosciences, Inc. (IDYA) delivered earnings and revenue surprises of 12.20% and 33.64%, respectively, for the quarter ended March 2022. Do the numbers hold clues to what lies ahead for the stock?

IDEAYA Biosciences, Inc. (IDYA) Reports Q1 Loss, Tops Revenue Estimates

Strong balance sheet of ~$346 million cash, cash equivalents and marketable securities as of March 31, 2022 is anticipated to fund planned operations into 2025 Targeting initiation of IDE397 Phase 1/2 monotherapy expansion and Phase 1 combination cohorts, and delivery of GSK option data package mid-year 2022 Darovasertib and crizotinib Phase 1/2 clinical combination data update and regulatory guidance on potential registration-enabling trial anticipated mid-year 2022 On-track to submit an IND in Q4 2022 for IDE161, a PARG development candidate, and to nominate a Pol Theta development candidate in Q2 2022 SOUTH SAN FRANCISCO, Calif. , May 10, 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 first quarter ended March 31, 2022.

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

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 Series Monday, May 16 at 10:00am ET Fireside 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 ET Fireside chat with Yujiro Hata, Chief Executive Officer, IDEAYA Biosciences, hosted by Charles Zhu, Ph.D.

IDEAYA Biosciences to Participate in Investor Conferences in May 2022

-  Darovasertib designated as an Orphan Drug by the U.S. FDA, entitling IDEAYA to certain tax credits, exemption from user fees, and potential statutory marketing exclusivity -  Targeting a clinical data update for darovasertib and crizotinib combination and FDA regulatory guidance for a potential registration-enabling trial design in mid-2022 SOUTH SAN FRANCISCO, Calif. , May 2, 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 orphan-drug designation to darovasertib, a potential first-in-class protein kinase C (PKC) inhibitor, for the treatment of uveal melanoma.

IDEAYA Biosciences Receives Orphan Drug Designation for Darovasertib, a PKC Inhibitor, for the Treatment of Uveal Melanoma

- Dr. Mackey formerly served as Senior Vice President of Pfizer Worldwide Research and Development and as Director of Pfizer's La Jolla Laboratories SOUTH SAN FRANCISCO, Calif. , April 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 the appointment of Catherine Mackey, Ph.D.

IDEAYA Biosciences Appoints Catherine Mackey, Ph.D., to its Board of Directors

IDEAYA Biosciences, Inc. (IDYA) CEO Yujiro Hata on Q4 2021 Results and Interim Clinical Data Update - Earnings Call Transcript

- Strong balance sheet of ~$368 million cash, cash equivalents and marketable securities as of December 31, 2021 is anticipated to fund planned operations into 2025 - Enrolling into IDE397 Cohort 6 with no observed drug-related serious adverse events and without observing maximum tolerated dose through Cohort 5 - Observed robust dose-proportional pharmacokinetic exposures and exposure-dependent pharmacodynamic modulation of S-adenosyl methionine (SAM) in plasma and of symmetric dimethyl arginine (SDMA) in tumor biopsy samples from Phase 1 dose escalation cohorts - Targeting IDE397 monotherapy cohort expansion and initiation of combination cohorts mid-year 2022, the timing of which may be influenced by observing the MTD  - Darovasertib and crizotinib clinical combination data presented in December 2021 showed robust clinical activity with manageable side effect profile, including 100% DCR (n=16) - Targeting additional darovasertib and crizotinib clinical combination data mid-year 2022,  the timing of which may be influenced by data maturity, including observation of median duration of response (DOR) and/or median progression free survival (mPFS) - Expanded relationship with Pfizer under a clinical collaboration and supply agreement to support clinical evaluation of darovasertib and crizotinib combination therapy in a potential registration-enabling clinical trial in MUM, subject to FDA guidance on trial design, and in additional cMET-driven tumors such as NSCLC and/or HCC, subject to preclinical validation SOUTH SAN FRANCISCO, Calif., March 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 year ended December 31, 2021.

IDEAYA Biosciences, Inc. Reports 2021 Financial Results and Provides Business Update

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 of Phase 1/2 monotherapy cohort expansions in NSCLC and esophagogastric cancer, as well as initiation of combination cohorts, in mid-year 2022 Targeting delivery of option data package to GSK mid-year 2022, including preclinical, and clinical adverse events, pharmacokinetic, and plasma and tumor pharmacodynamic data If GSK elects to opt-in, IDEAYA entitled to receive a $50 million option exercise payment, with ongoing development cost sharing of 80% GSK / 20% IDEAYA, and aggregate development / regulatory milestones of $465 million SOUTH SAN FRANCISCO, Calif. , March 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, announced interim Phase 1 clinical data for IDE397, a potential best in class methionine adenosyltransferase 2a (MAT2A) inhibitor.

IDEAYA Biosciences Reports IDE397 Interim Phase 1 Clinical Data

Pfizer

SOUTH SAN FRANCISCO, Calif., March 14, 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 entered into additional clinical trial collaboration and supply agreements with Pfizer Inc. (NYSE: PFE) to support further evaluation of darovasertib and crizotinib combination therapy in a Phase 2 potential registration-enabling clinical trial in patients with metastatic uveal melanoma (MUM) and in a Phase 1 clinical trial in patients with cMET-driven tumors, such as hepatocellular carcinoma (HCC) and/or non-small cell lung cancer (NSCLC).

IDEAYA and Pfizer Expand Clinical Trial Collaboration and Supply Agreements for Evaluation of Darovasertib and Crizotinib Combination in Metastatic Uveal Melanoma and Additional cMET-Driven Tumors

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 Biosciences Announces Investor Webcast to Report Interim IDE397 Phase 1 Clinical Data and Corporate Update

SOUTH SAN FRANCISCO, Calif., March 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 March 2022.

IDEAYA Biosciences to Participate in Investor Conferences in March 2022

Steven Cohen (Trades, Portfolio), leader of Point72 Asset Management, disclosed earlier this week he increased his stake in IDEAYA Biosciences Inc. ( IDYA , Financial) by 52.12%.

Steven Cohen's Interest in IDEAYA Increases

SOUTH SAN FRANCISCO, Calif., Feb. 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 an investor conference in February 2022.

IDEAYA Biosciences to Participate in Investor Conferences in February 2022

SOUTH SAN FRANCISCO, Calif., Jan. 31, 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 initiation of IND-enabling studies for IDE161, a potential first-in-class PARG inhibitor development candidate.

IDEAYA Advances First-in-Class PARG Development Candidate, IDE161, into IND-Enabling Studies and Exercises Option with Cancer Research UK and University of Manchester for Exclusive Worldwide License

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