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, 2024 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced its participation in upcoming investor relations events.

IDEAYA Biosciences to Participate in Upcoming February 2024 Investor Relations Events

IDEAYA Biosciences, Inc. (IDYA) saw its shares surge in the last session with trading volume being higher than average. The latest trend in earnings estimate revisions may not translate into further price increase in the near term.

IDEAYA Biosciences, Inc. (IDYA) Moves 7.6% Higher: Will This Strength Last?

SOUTH SAN FRANCISCO, Calif. , Jan. 7, 2024 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced its participation at the 42nd Annual J.P.

IDEAYA Biosciences Announces Participation at the 42nd Annual J.P. Morgan Healthcare Conference and 2024 Corporate Guidance

SOUTH SAN FRANCISCO, Calif. , Dec. 5, 2023 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced its participation in upcoming investor relations event.

IDEAYA Biosciences to Participate in Upcoming December 2023 Investor Relations Event

Entered into Clinical Study Collaboration and Supply Agreement with Gilead to evaluate IDE397, IDEAYA's MAT2A inhibitor, in combination with sacituzumab-govitecan-hziy ("Trodelvy") Gilead's Trop-2 directed ADC, in MTAP-deletion bladder cancer Potential first-in-class MAT2A-Trop2 ADC clinical combination targets two distinct, mechanistically complementary, nodes of MTAP-deletion bladder cancer pathway MTAP-deletion prevalence in bladder cancer is estimated to be approximately 26%    IDEAYA will sponsor the clinical trial and Gilead will provide Trodelvy SOUTH SAN FRANCISCO, Dec. 4, 2023 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced it has entered into a clinical study collaboration and supply agreement with Gilead Sciences, Inc. (Gilead) to evaluate the efficacy and safety of IDE397, its investigational, potential first-in-class, small molecule MAT2A inhibitor, in combination with Gilead's sacituzumab-govitecan-hziy ("Trodelvy"), a Trop-2 directed antibody-drug conjugate (ADC), in a Phase 1 clinical trial.  "We are pleased to collaborate with Gilead to evaluate this potential first-in-class Trop-2 directed ADC and MAT2A clinical combination in MTAP-deletion bladder cancer.

IDEAYA Announces Clinical Study Collaboration with Gilead Sciences to Evaluate Trodelvy® and IDE397 Combination in MTAP-Deletion Bladder Cancer

SOUTH SAN FRANCISCO, Calif. , Dec. 3, 2023 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced agenda topics for its Investor R&D Day.

IDEAYA Announces Agenda for Investor R&D Day Webcast on December 4, 2023

The mean of analysts' price targets for IDEAYA Biosciences, Inc. (IDYA) points to a 25.5% 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.

Can IDEAYA Biosciences, Inc. (IDYA) Climb 25.48% to Reach the Level Wall Street Analysts Expect?

IDEAYA Biosciences, Inc. (IDYA) came out with a quarterly loss of $0.46 per share versus the Zacks Consensus Estimate of a loss of $0.47. This compares to earnings of $0.04 per share a year ago.

IDEAYA Biosciences, Inc. (IDYA) Reports Q3 Loss, Lags Revenue Estimates

Strong balance sheet of $511.1 million of cash, cash equivalents and marketable securities as of September 30, 2023, supplemented by $134.7 million estimated net proceeds from subsequent follow-on financing and $10.0 million receivable from GSK milestones Multiple patients dosed and international site activation and enrollment ongoing in Phase 2/3 potential registrational trial evaluating darovasertib and crizotinib combination in 1L HLA-A2-negative MUM, and proffered paper oral presentation at ESMO 2023 Enrollment is ongoing in the Phase 1/2 study with IDE397 (MAT2A) and AMG 193 (PRMT5MTA) in MTAP-deletion solid tumors Demonstrated eye preservation in 3 of 6 (50%) evaluable patients treated with darovasertib as neoadjuvant therapy for primary UM; observed PRs by RECIST 1.1 in 2 of 4 (50%) GNAQ/11 cutaneous melanoma patients on darovasertib and crizotinib Reported PRs by RECIST 1.1 and initiated IDE161 Ph1 expansion in HRD+ solid tumor types, and received Fast Track Designation for IDE161 in BRCA 1/2 ovarian and breast cancer IND clearance for GSK101 (IDE705) Pol Theta Helicase inhibitor ($7.0 million milestone), and selected Werner Helicase Inhibitor Development Candidate ($3.0 million milestone) Targeting multiple wholly-owned next generation development candidate nominations in 2024, including in MTAP-deletion, further advancing IDEAYA's multi-pronged strategy Hosting Investor R&D Day on December 4, 2023, with participation from GSK and KOL SOUTH SAN FRANCISCO, Calif. , Nov. 7, 2023 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a 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, 2023.

IDEAYA Biosciences, Inc. Reports Third Quarter 2023 Financial Results and Provides Business Update

SOUTH SAN FRANCISCO, Calif. , Nov. 1, 2023 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced its participation in the Jefferies London Healthcare Conference and its plans to host an Investor R&D Day in December 2023.

IDEAYA Biosciences Announces Plans for Investor R&D Day and Participation in Jefferies London Healthcare Conference

Ideaya plans to sell $125 million worth of stock and stock warrants in the near future. The shares and warrants have been priced below where Ideaya stock has been trading recently.

Why Ideaya Biosciences Stock Is Plummeting Today

60% confirmed ORR% by RECIST 1.1 in HLA-A2(+) in 1L MUM, and 42% confirmed ORR% by RECIST 1.1 in HLA-A2(-) in 1L MUM Median PFS of 7.1 months in 1L MUM and 11 months in hepatic-only MUM On further follow-up, ~30% of any-line MUM treated >1 year and multiple PRs on treatment >2 years, with potential for further enhancement with ~20% of patients ongoing treatment Historical ORR% and median PFS by other therapies in MUM have ranged from 0% to 5% and 2 to 3 months, respectively 94% ctDNA molecular response rate observed in any-line MUM ~70% of MUM patients were HLA-A2(-) based on 149 patients tested for HLA-A2 status 2 of 4 (50%) GNAQ/11 cutaneous melanoma patients on darovasertib combo observed PRs by RECIST 1.1, with responses on treatment approximately 600 days 50% eye preservation rate (3 of 6 evaluable patients) in enucleation neoadjuvant IST cohort with darovasertib monotherapy until maximal benefit Synthetic Lethality: Updates on PRs by RECIST 1.1 for IDE397/MAT2A and IDE161/PARG Updated corporate presentation with clinical data updates on darovasertib, IDE397/MAT2A, and IDE161/PARG is available on IDEAYA homepage SOUTH SAN FRANCISCO, Calif. , Oct. 23, 2023 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announces clinical data presented at a proffered paper session of the European Society of Medical Oncology Congress 2023 (ESMO 2023) from the company's ongoing Phase 2 clinical trial evaluating darovasertib in combination with crizotinib in patients having metastatic uveal melanoma (MUM).

IDEAYA Announces Top-Line Phase 2 Results at ESMO 2023 of Darovasertib and Crizotinib Combo in MUM, and Clinical Efficacy Updates for Neoadjuvant UM, GNAQ/11 Cutaneous Melanoma, and Synthetic Lethality Pipeline

IDEAYA Biosciences, Inc. (IDYA) Surges 7.6%: Is This an Indication of Further Gains?

Proffered paper oral presentation at ESMO 2023 scheduled for Monday, October 23, 2023, at 8:50 am CEST will be presented by Dr. Meredith McKean, Sara Cannon Research Institute Darovasertib and Crizotinib combination observed manageable safety profile and clinical efficacy that appears superior to current standard of care in MUM Clinical data update, will include confirmed ORR by RECIST 1.1 by HLA-A2 status, median progression free survival, HLA-A2(+) and (-) status prevalence across darovasertib clinical trials, and ctDNA molecular response rate Press release summarizing the top-line results will be available on Monday, October 23, 2023, at approximately 6:00 am ET SOUTH SAN FRANCISCO, Calif. , Oct. 17, 2023 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announces the publication of the abstract for a proffered paper session at the European Society of Medical Oncology Congress 2023 (ESMO 2023) relating to selected clinical data from the company's ongoing Phase 2 clinical trial evaluating darovasertib in combination with crizotinib in patients having metastatic uveal melanoma (MUM).

IDEAYA Biosciences Announces Proffered Paper Oral Presentation at ESMO 2023 for Phase 2 Clinical Data Update for Darovasertib and Crizotinib Combination in Metastatic Uveal Melanoma

Initiated Phase 2 expansion of darovasertib and crizotinib combination in GNAQ/11 metastatic cutaneous melanoma based on preliminary clinical efficacy observed Approximately 5% of cutaneous melanoma patients harbor a GNAQ/11 mutation, with an estimated annual incidence of ~5,000 patients in the US and ~8,000 patients in the EU28 and total prevalence of ~70,000 patients in the US and ~110,000 patients in the EU28 GNAQ/11 is on multiple NGS and liquid biopsy platforms, enabling patient identification SOUTH SAN FRANCISCO, Calif. , Oct. 16, 2023 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announces initiation of a Phase 2 expansion of the darovasertib and crizotinib combination in GNAQ/11 metastatic cutaneous melanoma.

IDEAYA Biosciences Announces Phase 2 Expansion of Darovasertib and Crizotinib Combination in GNAQ/11 Metastatic Cutaneous Melanoma

Selected a Werner Helicase Inhibitor Development Candidate in collaboration with GSK Observed monotherapy complete responses preclinically in multiple in vivo xenograft MSI-High models and pharmacological sensitivity in therapy-refractory CRC organoid models Earned $3 million milestone from GSK in connection with IND-enabling studies with potential for up to an additional $17 million aggregate milestones through early Phase 1 Targeting an IND in 2024 to enable first-in-human clinical evaluation of Werner Helicase Inhibitor Development Candidate for patients having tumors with MSI-High Subject to IND submission and clearance, GSK will lead clinical development and the global research and development costs will be shared between GSK (80%) and IDEAYA (20%) IDEAYA will be eligible to receive additional development milestones of up to $465.0 million and commercial milestones of up to $475.0 million and 50% of U.S. net profits ­IDEAYA is hosting an Investor R&D Day in Q4 2023, with participation of GSK SOUTH SAN FRANCISCO, Calif. , Oct. 9, 2023 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announces selection of a Werner Helicase Inhibitor Development Candidate (DC) and Investor R&D Day.

IDEAYA Biosciences Announces Development Candidate Nomination of a Werner Helicase Inhibitor in Collaboration with GSK and Investor R&D Day

Fast Track designation granted by U.S. FDA for evaluation of IDE161 in adult patients with HR+, Her2-, BRCA1/2 mutant advanced or metastatic breast cancer patients who have been pretreated with hormonal, CDK4/6 inhibitor and PARP inhibitor therapies Represents a second indication in the IDE161 development program to receive Fast Track designation, complementing the designation for BRCA1/2 mutant ovarian cancer patients Ongoing Phase 1 expansion, with focus in ER+, Her2(-), HRD+ breast cancer, HRD+ ovarian cancer and other HRD+ solid tumors, including endometrial and colon cancer Targeting clinical program updates for IDE161 in Q4 2023 SOUTH SAN FRANCISCO, Calif. , Sept. 27, 2023 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to IDEAYA's development program investigating IDE161, a potent and selective inhibitor of poly (ADP-ribose) glycohydrolase (PARG), for the treatment of adult patients having advanced or metastatic hormone receptor positive (HR+), Her2- breast cancer with germline or somatic BRCA 1/2 mutations who have progressed following treatment with at least one line of a hormonal therapy, a CDK4/6 inhibitor therapy and a poly (ADP-ribose) polymerase (PARP) inhibitor therapy.

IDEAYA Biosciences Receives Fast Track Designation for IDE161 in a Second Indication for the Treatment of Pretreated, Advanced or Metastatic HR+, Her2-, BRCA1/2 mutant Breast Cancer

Fast Track designation granted by U.S. FDA for evaluation of IDE161 in adult patients with BRCA1/2 mutant advanced or metastatic ovarian cancer who are platinum resistant and have received prior antiangiogenic and PARP inhibitor therapies Enables IDE161 development program to access expedited regulatory review processes, including potential eligibility for accelerated approval / priority review Ongoing Phase 1 expansion, with focus in ER+, Her2(-), HRD+ breast cancer, HRD+ ovarian cancer and other HRD+ solid tumors, including endometrial and colon cancer SOUTH SAN FRANCISCO, Calif. , Sept. 26, 2023 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to IDEAYA's development program investigating IDE161, a potent and selective inhibitor of poly (ADP-ribose) glycohydrolase (PARG), for the treatment of adult patients having advanced or metastatic ovarian cancer with germline or somatic BRCA 1/2 mutations who are platinum resistant and have received prior antiangiogenic and poly (ADP-ribose) polymerase (PARP) inhibitor therapies.

IDEAYA Receives Fast Track Designation for Potential First-in-Class PARG Inhibitor, IDE161, for Treatment of Pretreated, Platinum-Resistant Advanced or Metastatic Ovarian Cancer Patients having tumors with BRCA1/2 Mutations

IDEAYA Biosciences specializes in precision oncology, has FDA clearance for a Phase 1/2 trial, and partnerships with Amgen and GSK. Financially stable with a 50-month cash runway, the company has multiple clinical and preclinical programs in its diversified pipeline. IDEAYA Biosciences has a strong financial position, diverse pipeline, and valuable partnerships, making it a recommended "Buy" in the biotech sector.

IDEAYA's Triple Threat: Melanoma, Money, And Momentum

Initiated IDE161 Phase 1 expansion based on preliminary tumor shrinkage observed in multiple HRD solid tumor patients, including an endometrial cancer subject with a first imaging assessment of a partial response and an 87% reduction of the CA-125 tumor marker Phase 1 expansion focus in ER+, Her2(-), HRD+ breast cancer representing ~10% to ~14% of breast cancer as well as HRD+ ovarian cancer and other HRD-associated solid tumors Demonstrated IDE161 target engagement based on pharmacodynamic modulation of PAR, and achieved human exposures correlating to tumor regressions in preclinical models IDE161 Phase 1 dose optimization ongoing to confirm move forward Phase 2 expansion dose Targeting IDE161 clinical program updates in H2 2023 SOUTH SAN FRANCISCO, Calif. , Sept. 11, 2023 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announces initiation of a Phase 1 monotherapy expansion in the first-in-human clinical trial evaluating IDE161 (NCT 05787587).

IDEAYA Announces Phase 1 Expansion and Preliminary Clinical Proof-of-Concept for Potential First-in-Class PARG Inhibitor IDE161 in HRD Solid Tumors

SOUTH SAN FRANCISCO, Calif. , Sept. 5, 2023 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced its participation in upcoming investor relations events.

IDEAYA Biosciences to Participate in Upcoming September 2023 Investor Relations Events

GSK101 (IDE705) is being developed as a potential first-in-class Pol Theta Helicase Inhibitor in combination with niraparib in GSK-sponsored Phase 1/2 clinical trial GSK101 and niraparib combination development will focus on advanced solid tumors with HR mutations or HRD, pursuant to the clinical protocol IDEAYA to receive a $7 million milestone payment upon IND acceptance, and potential future aggregate milestones of up to $950 million related to GSK101 Pol Theta inhibitors SOUTH SAN FRANCISCO, Calif. , Aug. 21, 2023 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced the clearance of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for initiation of a GSK-sponsored Phase 1/2 clinical trial to evaluate GSK101 (IDE705), a small molecule inhibitor of Pol Theta Helicase, in combination with niraparib, the GSK small molecule inhibitor of poly-(ADP-ribose) polymerase (PARP), for the treatment of patients having tumors with BRCA or other homologous recombination (HR) mutations or homologous recombination deficiency (HRD).

IDEAYA Biosciences Announces Clearance of IND Application for Pol Theta Helicase Development Candidate GSK101 (IDE705)

Dosed a first patient in a company-sponsored global Phase 2 clinical trial evaluating darovasertib as neoadjuvant and adjuvant therapy in primary uveal melanoma (UM) Preliminary clinical activity observed in primary UM, including tumor shrinkage in 9 of 9 patients following neoadjuvant therapy with darovasertib as monotherapy or in combination with crizotinib, two of whom were spared enucleation and preserved vision Targeting clinical data update in the fourth quarter of 2023 from the ongoing NADOM IST evaluating single-agent darovasertib as neoadjuvant therapy in primary UM patients ­(Neo)adjuvant UM has no approved systemic therapies with an annual incidence of ~8,700 patients and estimated prevalence of ~100,000 patients aggregate in the U.S. and Europe SOUTH SAN FRANCISCO, Calif. , Aug. 16, 2023 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced the achievement of First-Patient-In for the company-sponsored Phase 2 clinical trial evaluating darovasertib as neoadjuvant and adjuvant therapy in primary uveal melanoma (UM) patients.

IDEAYA Announces First-Patient-In for Company-Sponsored Phase 2 Clinical Trial Evaluating Darovasertib in (Neo)Adjuvant Uveal Melanoma

Ideaya Biosciences has made strong progress in the treatment of ocular cancer, with its stock price increasing over 150% since its IPO. The company's lead candidate, Darovasertib, has shown promising results in Phase 2 studies, with high response rates and a tolerable safety profile. Ideaya has initiated a potential registration-enabling Phase 2/3 clinical trial in combo with Pfizer's Xalkori - the market opportunity could be $500m - $1bn.

Ideaya Biosciences: Eye Cancer Therapy Drives Gains - More Upside Ahead

IDEAYA Biosciences, Inc. (IDYA) came out with a quarterly loss of $0.50 per share versus the Zacks Consensus Estimate of a loss of $0.53. This compares to loss of $0.57 per share a year ago.

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