IDYA IDEAYA Biosciences Inc.

19.18
+0.18  (+1%)
Previous Close 19
Open 19.49
52 Week Low 6
52 Week High 24.92
Market Cap $631,129,255
Shares 32,905,592
Float 28,885,982
Enterprise Value $344,395,576
Volume 37,199
Av. Daily Volume 202,816
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Upcoming Catalysts

Drug Stage Catalyst Date
IDE196 (basket)
Solid tumors
Phase 2
Phase 2
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IDE397
Solid tumors
Phase 1
Phase 1
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Drug Pipeline

Drug Stage Notes
IDE196 and binimetinib
Metastatic uveal melanoma (MUM)
Phase 1/2
Phase 1/2
Phase 1/2 data released April 16, 2021. 2/9 (22%) partial responses.
IDE196 and crizotinib
Metastatic uveal melanoma (MUM)
Phase 1
Phase 1
Phase 1 trial initiation announced January 5, 2021.

Latest News

  1. SOUTH SAN FRANCISCO, Calif., May 6, 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 participation at the following upcoming investor relations event.

    Investor Relations Event

    • 2021 JP Morgan Conference Call Series

      Fireside Chat with Analyst Anupam Rama

      Monday, May 10, 2021 at 11:00 am ET

    A live audio webcast of the event will be available by visiting the "Investors/News and Events/Investor Calendar" section of the IDEAYA website at https://ir.ideayabio.com/news-events/investor-calendar.  A replay of the webcast will be available for 30 days following the live event.

    About IDEAYA Biosciences

    IDEAYA is a synthetic lethality-focused precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics.  IDEAYA's approach integrates capabilities in identifying and validating translational biomarkers with drug discovery to select patient populations most likely to benefit from its targeted therapies.  IDEAYA is applying its early research and drug discovery capabilities to synthetic lethality – which represents an emerging class of precision medicine targets. 

    Forward-Looking Statements

    This press release contains forward-looking statements, including, but not limited to, statements related to participation in and/or presentation at certain investor relations events. IDEAYA undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of IDEAYA in general, see IDEAYA's recent Annual Report on Form 10-K filed on March 23, 2021 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.

     

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  2. SOUTH SAN FRANCISCO, Calif., April 19, 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 the agenda for its inaugural Synthetic Lethality Investor Day. The event will be held virtually on Tuesday, April 20, 2021, at 1:00 pm - 3:00 pm ET (10:00 am - 12:00 noon PT). The agenda will include scientific presentations from IDEAYA, GlaxoSmithKline (GSK) and several key opinion leaders.

    Presenters

    • Alan D'Andrea, M.D., Director, Center of DNA Damage and Repair, Dana Farber Cancer Institute of Harvard Medical School
    • William Sellers, M.D., Core Institute Member and Director of the Cancer Program of the Broad Institute of MIT and Harvard
    • Benjamin Schwartz, Ph.D., Vice President, Head of Oncology Synthetic Lethality Research Unit, GlaxoSmithKline (GSK)
    • Yujiro Hata, President and Chief Executive Officer, IDEAYA Biosciences
    • Michael Dillon, Ph.D., SVP and Chief Scientific Officer, IDEAYA Biosciences
    • Mark Lackner, Ph.D., SVP and Head of Biology and Translational Sciences, IDEAYA Biosciences
    • Matt Maurer, M.D., VP and Head of Clinical Oncology and Medical Affairs, IDEAYA Biosciences

    Program Agenda (ET)

    • 1:00 pm - Welcome and Introduction
      • Yujiro Hata
    • 1:10 pm - Synthetic Lethality: Emerging Area within Precision Medicine and GSK-IDEAYA Partnership
      • Ben Schwartz (GSK)
    • 1:20 pm - IDE397: Targeting MAT2A in MTAP-Deleted Tumors
      • Bill Sellers (Broad), Mark Lackner, Matt Maurer
    • 1:50 pm - Werner Helicase (Roundtable): Compelling Synthetic Lethality Target
      • Introduction: Ben Schwartz (GSK)
      • Panelists:Bill Sellers (Broad), Mike Dillon, Ben Schwartz
      • Moderator: Yujiro Hata
    • 2:10 pm - Pol Theta: Key Target in MMEJ DNA Damage Repair Pathway
      • Alan D'Andrea (Harvard), Mike Dillon, Ben Schwartz (GSK)
    • 2:30 pm - PARG: Novel Target in Clinically Validated Pathway
      • Mike Dillon, Mark Lackner
    • 2:45 pm - Analyst Q&A / Closing
      • Yujiro Hata
    • 3:00 pm - Adjourn

    Registration for the IDEAYA Synthetic Lethality Investor Day and additional information on the event is available on IDEAYA's website at https://ir.ideayabio.com/events.

    About IDEAYA Biosciences

    IDEAYA is a synthetic lethality-focused precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics. IDEAYA's approach integrates capabilities in identifying and validating translational biomarkers with drug discovery to select patient populations most likely to benefit from its targeted therapies. IDEAYA is applying its early research and drug discovery capabilities to synthetic lethality – which represents an emerging class of precision medicine targets. 

    Forward-Looking Statements

    This press release contains forward-looking statements, including, but not limited to, statements related to the timing, content and participants of the Synthetic Lethality Investor Day. Such forward-looking statements involve substantial risks and uncertainties that could cause IDEAYA's preclinical and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including IDEAYA's programs' early stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, IDEAYA's ability to successfully establish, protect and defend its intellectual property, the effects on IDEAYA's business of the worldwide COVID-19 pandemic, and other matters that could affect the sufficiency of existing cash to fund operations. IDEAYA undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of IDEAYA in general, see the IDEAYA Annual Report for the year ended December 31, 2020 on Form 10-K filed on March 23, 2021 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.   

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  3. SOUTH SAN FRANCISCO, Calif., April 16, 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 clinical data from the ongoing Phase 1/2 trial evaluating darovasertib (IDE196) monotherapy and binimetinib combination therapy in patients with solid tumors, including Metastatic Uveal Melanoma (MUM) and Skin Melanoma (ClinicalTrials.gov Identifier: NCT03947385).

    "The darovasertib single-agent one-year survival data in MUM is encouraging and compares favorably to historical survival rates in this indication, where a therapy has yet to be approved," said Meredith McKean, MD, MPH, Associate Director, Melanoma and Skin Cancer Research,  Sarah Cannon Research Institute at Tennessee Oncology, Nashville, TN. "The early partial responses observed in the darovasertib and binimetinib combination in MUM are exciting where historical response rates have been from zero to low to mid-single-digit percent, and we look forward to seeing the data set mature," said Richard Carvajal, MD, Co-Leader, Precision Oncology and Systems Biology Program, Director of Experimental Therapeutics and Director of the Melanoma Service, Columbia University Irving Medical Center.

    Darovasertib Monotherapy Clinical Efficacy in Solid Tumors

    There have been 81 darovasertib monotherapy BID MUM and 7 Skin Melanoma patients enrolled across the IDEAYA and Novartis Phase 1/2 clinical trials at the time of data and analyses cutoff on April 13th, 2021, with an aggregate of 88 patients evaluable for safety and 81 evaluable for efficacy based on RECIST 1.1.  Reported data is preliminary and based on an unlocked database.  Evaluation and follow-up of the monotherapy arm of the clinical trial continues. 

    Darovasertib Monotherapy Preliminary Results Summary

    • 57% 1-Year Overall Survival (OS) Rate was observed in predominantly second line, third line and heavily pre-treated (out to 7 and 8 lines of prior treatment) Metastatic Uveal Melanoma (MUM) patients with 95% CI (44%, 69%); Historical 1-Year OS Rate in similar MUM populations has been reported at 37% (Source: Rantala 2019, Immunocore March 2021 presentation, Synthetic Control Arm, 2+ L)
    • Median OS of 13.2 months was observed in predominanantly second line, third line and heavily pre-treated (out to 7 and 8 lines of prior treatment) MUM patients with 95% CI (10.7 months, Not Reached); Historical median OS in similar MUM populations has been reported at approximately 7 months (Source: Rantala 2019, Immunocore March 2021, Synthetic Control Arm, 2+ L)
    • 61% (n=46) of MUM patients out of 75 evaluable had tumor reduction per RECIST 1.1. evaluation, including 15 patients (20%) with >30% target lesion reduction and one confirmed complete response. In the Skin Melanoma cohort, 80% (n=4) of evaluable patients (n=5) had tumor reduction per RECIST 1.1. evaluation, including one confirmed partial response

    Darovasertib Monotherapy Clinical Safety

    Overall safety profile of darovasertib monotherapy is consistent with prior reports (Ref. 2019 AACR) and includes primarily common low grade but manageable GI toxicities and hypotension.

    Preliminary Darovasertib and Binimetinib Combination Clinical Efficacy in MUM

    The combination of darovasertib plus binimetinib is being evaluated pursuant to a clinical trial collaboration and drug supply agreement with Pfizer, which the companies have amended to support a target enrollment of approximately 40 patients in the darovasertib and binimetinib clinical combination arm in MUM.  At the time of the data and analyses cutoff on April 13th, 2021, twenty four MUM patients have enrolled in the darovasertib and binimetinib combination study, including 8 patients dosed in the Phase 1/2 dose expansion cohort of the combination study.  Reported data is preliminary and based on an unlocked database.  Enrollment in the darovasertib and binimetinib combination arm of the clinical trial is ongoing. 

    Darovasertib and Binimetinib Combination Therapy Preliminary Data Summary

    • 2 partial responses observed out of nine MUM patients with at least 2 post-baseline scans (22%) by RECIST 1.1 guidelines, including 1 confirmed partial response and 1 unconfirmed partial response (-40.5%) awaiting a confirmatory scan
    • 79% of evaluable MUM patients with at least 1 post-baseline scan show tumor reduction; follow-up for overall response is still immature
    • Combination doses for Phase 1/2 dose expansion have been selected based on anticipation of activity and overall tolerability in a larger treatment cohort
    • Treatment-related adverse events observed in the darovasertib and binimetinib combination arm in MUM primarily include: nausea, vomiting, diarrhea, rash, edema, AST/ALT increase and CK increase (>10%); and hypotension (<10%)

    IDEAYA's clinical development strategy in MUM is focused on darovasertib combinations, including with binimetinib, a MEK inhibitor, and in a separate clinical study with crizotinib, a cMET inhibitor, each pursuant to the  clinical trial collaboration and drug supply agreement with Pfizer.

    Darovasertib Investor Day Webcast

    IDEAYA will host an investor webcast with a  presentation at 8:00 a.m. ET today. A link to the webcast and a copy of the presentation is posted on the Investor Relations Events section of the Company's website at  https://ir.ideayabio.com/events.  The update may also be accessed by dialing 1-866-248-8441 (domestic) or 1-720-452-9102 (international) five minutes prior to the start of the call and providing the passcode 2793795. An archived replay of the webcast will be accessible for 90 days following the event.

    Meredith McKean, MD, MPH, Associate Director, Melanoma and Skin Cancer Research, Sarah Cannon Research Institute at Tennessee Oncology, Nashville, TN, and Richard Carvajal, MD, Co-Leader, Precision Oncology and Systems Biology Program, Director of Experimental Therapeutics and Director of the Melanoma Service, Columbia University Irving Medical Center, will participate in the webcast.

    About IDEAYA Biosciences

    IDEAYA is a synthetic lethality-focused precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics.  IDEAYA's approach integrates capabilities in identifying and validating translational biomarkers with drug discovery to select patient populations most likely to benefit from its targeted therapies.  IDEAYA is applying its early research and drug discovery capabilities to synthetic lethality – which represents an emerging class of precision medicine targets. 

    Forward-Looking Statements

    This press release contains forward-looking statements, including, but not limited to, statements related to the darovasertib (IDE196) clinical development strategy.  Such forward-looking statements involve substantial risks and uncertainties that could cause IDEAYA's preclinical and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including IDEAYA's programs' early stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, IDEAYA's ability to successfully establish, protect and defend its intellectual property, the effects on IDEAYA's business of the worldwide COVID-19 pandemic, and other matters that could affect the sufficiency of existing cash to fund operations. IDEAYA undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of IDEAYA in general, see IDEAYA's recent Annual Report on Form 10-Kfiled on March 23, 2021and any current and periodic reports filed with the U.S. Securities and Exchange Commission.  

     

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  4. SOUTH SAN FRANCISCO, Calif., April 15, 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 that the company plans to issue a pre-market press release and conduct a webcast on Friday, April 16, 2021, to discuss clinical data from the ongoing Phase 1/2 trial evaluating darovasertib (IDE196) as monotherapy and darovasertib and binimetinib combination in patients with metastatic uveal melanoma (MUM) (ClinicalTrials.gov Identifier: NCT03947385).

    IDEAYA will host a Darovasertib Investor Day, including a conference call and webcast with participation of leading clinical investigators, at 8:00 a.m. ET on Friday, April 16, 2021.  The link to the webcast of the conference call will be posted on the Investor Relations Events section of the Company's website at: https://ir.ideayabio.com/events.  The update may also be accessed by dialing 1-866-248-8441 (domestic) or 1-720-452-9102 (international) five minutes prior to the start of the call and providing the passcode 2793795. An archived replay will be accessible for 90 days following the event.

    IDEAYA also announced the International Nonproprietary Name (INN) for IDE196 is "darovasertib" as registered with the World Health Organization (WHO)'s Programme and Classification of Medical Products.

    About IDEAYA Biosciences

    IDEAYA is a synthetic lethality-focused precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics.  IDEAYA's approach integrates capabilities in identifying and validating translational biomarkers with drug discovery to select patient populations most likely to benefit from its targeted therapies.  IDEAYA is applying its early research and drug discovery capabilities to synthetic lethality – which represents an emerging class of precision medicine targets. 

    Forward-Looking Statements

    This press release contains forward-looking statements, including, but not limited to, statements related to the Darovasertib (IDE196) Investor Day.  Such forward-looking statements involve substantial risks and uncertainties that could cause IDEAYA's preclinical and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including IDEAYA's programs' early stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, IDEAYA's ability to successfully establish, protect and defend its intellectual property, the effects on IDEAYA's business of the worldwide COVID-19 pandemic, and other matters that could affect the sufficiency of existing cash to fund operations. IDEAYA undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of IDEAYA in general, see IDEAYA's recent Annual Report on Form 10-K filed on March 23, 2021 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.  

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  5. SOUTH SAN FRANCISCO, Calif., April 15, 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 First-Patient-In (FPI) in the Phase 1 clinical trial evaluating IDE397 (ClinicalTrials.gov Identifier: NCT04794699).  IDE397 is a potential best-in-class methionine adenosyltransferase 2a (MAT2A) inhibitor being evaluated in cancer patients harboring methylthioadenosine phosphorylase (MTAP) deletion. 

    "We are excited to dose the first patient in the evaluation of IDE397 targeting MAT2A in MTAP deletion patients.  IDE397 has the potential to be broadly impactful for cancer patients with MTAP deletion, which is prevalent in approximately 15% of solid tumors," said Anthony Tolcher, M.D., Director of Clinical Research, Founder and CEO at NEXT Oncology.

    IDE397 is an internally discovered potential best-in-class MAT2A inhibitor that received IND-clearance from the U.S. FDA to initiate Phase 1 in Q1 2021.  As reported at AACR 2021, IDE397 demonstrated significant single-agent anti-tumor activity in a 40-plus MTAP-deletion study, including tumor regressions, across major solid tumor types, such as NSCLC, gastric, esophageal, bladder, among others.  In addition to IDE397 monotherapy, IDEAYA is evaluating multiple potential combinations preclinically, including in the PRMT pathway and with taxanes, among others. Multiple clinical trial sites are being activated across the U.S. to evaluate IDE397 clinically, and MTAP-deletion patients will be identified for study enrollment through commercially available Next Generation Sequencing (NGS) platforms and with an MTAP-IHC assay which IDEAYA has developed in collaboration with Ventana.

    "We believe that IDE397 is a differentiated small molecule MAT2A inhibitor, with the potential for monotherapy clinical development in genetically defined MTAP deleted cancers," said Matthew Maurer, M.D., Vice President, Head of Clinical Oncology and Medical Affairs at IDEAYA Biosciences.  "Dosing our first patient for IDE397 in our Phase 1 MTAP-deletion solid tumor trial is a substantial company milestone. IDEAYA is targeting to advance our next two Synthetic Lethality programs in PARG and Pol Theta to development candidate stage in 2021 and advancing our internal pipeline in the MTAP-deletion synthetic lethality space to complement our Phase 1 MAT2A inhibitor IDE397," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences. 

    About IDEAYA Biosciences

    IDEAYA is a synthetic lethality-focused precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics.  IDEAYA's approach integrates capabilities in identifying and validating translational biomarkers with drug discovery to select patient populations most likely to benefit from its targeted therapies.  IDEAYA is applying its early research and drug discovery capabilities to synthetic lethality – which represents an emerging class of precision medicine targets. 

    Forward-Looking Statements

    This press release contains forward-looking statements, including, but not limited to, statements related to (i) the activation of clinical trial sites, (ii) the utilization of NGS platforms and MTAP-IHC assay, (iii) the timing and content of IDE397 program update, (iv) the best-in class potential of IDE397, (v) the potential impact and single agent activity IDE397 and (vi) the timing for development candidate identification for PARG and Pol Theta programs.  Such forward-looking statements involve substantial risks and uncertainties that could cause IDEAYA's preclinical and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including IDEAYA's programs' early stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, IDEAYA's ability to successfully establish, protect and defend its intellectual property, the effects on IDEAYA's business of the worldwide COVID-19 pandemic, and other matters that could affect the sufficiency of existing cash to fund operations. IDEAYA undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of IDEAYA in general, see IDEAYA's recent Annual Report on Form 10-K filed on March 23, 2021 and any current and periodic reports filed with the U.S. Securities and Exchange Commission. 

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