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.

Independent Data Monitoring Committee (IDMC) recommends move-forward dose in Part 2a of potential registration-enabling trial in 1L HLA-A2-Negative MUM, based on clinical efficacy and safety observed Over 185 patients enrolled in potential registration-enabling trial in 1L HLA-A2-Negative MUM, and the darovasertib and crizotinib combination has received U.S. Food and Drug Administration (FDA) Fast Track designation in MUM SAN FRANCISCO , Dec. 17, 2024 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, today announced the Independent Data Monitoring Committee (IDMC) recommendation of a move-forward dose and the completion of the Part 2a dose optimization consistent with the U.S. Food and Drug Administration's (FDA) Project Optimus guidelines for the potential registration-enabling Phase 2/3 trial evaluating the combination of darovasertib and crizotinib in the first-line (1L) setting in patients with HLA-A2-negative (HLA-A2(-)) metastatic uveal melanoma (MUM). "We are pleased with the recommendation of the IDMC and the selection of the move-forward dose for our potential registration-enabling trial evaluating the darovasertib and crizotinib combination in first-line HLA-A2(-) MUM patients.

IDEAYA Announces IDMC Recommendation of Move-Forward Dose in Part 2a of Registration-Enabling Trial of Darovasertib and Crizotinib Combination in 1L HLA-A2-Negative Metastatic Uveal Melanoma

Nominated development candidate IDE251, a potential first-in-class KAT6/7 inhibitor IDE251 is targeted to be evaluated in breast and NSCLC with 8p11 amplification, and in the setting of lineage addiction. 8p11 amplification prevalence is projected to be ~15% in breast cancer and ~17.5% in squamous NSCLC Demonstrated robust and durable monotherapy anti-tumor activity in multiple biomarker positive breast and lung xenografts models Targeting IND submission for IDE251 in 2025 SOUTH SAN FRANCISCO, Calif.

IDEAYA Announces Development Candidate Nomination of IDE251, a Potential First-in-Class KAT6/7 Dual Inhibitor Targeting 8p11 Amplification Tumors in Breast and Lung Cancers

SOUTH SAN FRANCISCO, Calif. , Dec. 11, 2024 /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 virtual Investor R&D Day.

IDEAYA Announces Agenda for Investor R&D Day Webcast on December 16, 2024

First patient dosed with combination of IDE161, IDEAYA's investigational, potential first-in-class PARG inhibitor, in combination with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy The IDEAYA-sponsored Phase 1 clinical trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of IDE161 in combination with KEYTRUDA in patients with MSI-high and MSS endometrial cancer Selected initial Phase 1/2 expansion dose for IDE161 monotherapy in a priority solid tumor type, based on AE profile and preliminary clinical efficacy observed   SOUTH SAN FRANCISCO, Calif. , Dec. 10, 2024 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced that it has dosed the first patient in the IDEAYA-sponsored Phase 1 trial evaluating the combination of IDE161, the company's investigational, potential first-in-class, small molecule poly (ADP-ribose) glycohydrolase, or PARG, inhibitor, in combination with Merck's (known as MSD outside of the US and Canada) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in endometrial cancer patients with high microsatellite instability (MSI-high) and microsatellite stable(MSS).

IDEAYA Announces First-Patient-In for Phase 1 Clinical Trial Evaluating IDE161 in Combination with KEYTRUDA® (pembrolizumab) in Patients with Endometrial Cancer

IDE892 is a potent and selective MTA-cooperative PRMT5 inhibitor with favorable ADME properties; demonstrating robust MTAP deletion-specific pathway suppression and highly durable antitumor activity in combination with IDE397 IND-enabling studies ongoing and targeting IND-filing for IDE892 in mid-2025 SOUTH SAN FRANCISCO, Calif. , Dec. 9, 2024 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, today announced development candidate nomination of IDE892, a potential best-in-class MTA-cooperative PMRT5 inhibitor.

IDEAYA Biosciences Announces Development Candidate Nomination of IDE892, a Potential Best-in-Class MTA-cooperative PRMT5 Inhibitor

SOUTH SAN FRANCISCO, Calif. , Dec. 6, 2024 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, today announced that, on December 2, 2024, the Compensation Committee of IDEAYA's Board of Directors granted non-qualified stock options to purchase an aggregate of 170,000 shares of the Company's common stock to a newly hired employee.

IDEAYA Biosciences Announces Inducement Grants under Nasdaq Listing Rule 5635(c)(4)

Ideaya Biosciences' stock experienced volatility, with significant movements driven by clinical data releases and a secondary offering, but currently trades near its December levels. Ideaya's lead candidate, Darovasertib, shows promising efficacy in metastatic uveal melanoma, especially in combination with crizotinib, addressing a significant unmet medical need. IDE397, another key asset, demonstrated positive interim data in MTAP-deletion cancers, showing a 39% ORR and a strong safety profile.

Ideaya Biosciences: Long-Tailed Pipeline With Positive Mid-Stage Data And Huge Cash

SOUTH SAN FRANCISCO, Calif. , Dec. 2, 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 Announces Participation in Upcoming December 2024 Investor Relations Events

Brings over 20-year global commercialization experience in oncology with leading biopharmaceutical companies Gilead Sciences and Bristol Myers Squibb, including leadership of multiple commercial launches for products including Trodelvy® and Opdivo® SOUTH SAN FRANCISCO, Calif. , Nov. 18, 2024 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, today announced the appointment of Stu Dorman as Chief Commercial Officer.

IDEAYA Biosciences Appoints Stu Dorman as Chief Commercial Officer

SOUTH SAN FRANCISCO, Calif. , Nov. 12, 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 the Jefferies London Healthcare Conference and its plans to host an Investor R&D Day in December 2024.

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

Nominated IDE034 (BCG034) as a development candidate, a potential first-in-class B7H3/PTK7 topo-I-payload bispecific antibody drug conjugate (BsADC) Option exercised for an exclusive worldwide license for IDE034 from Biocytogen Targeting an IND-filing for IDE034 in 2025 to enable first-in-human clinical evaluation of B7H3/PTK7 topo-I-payload BsADC program IDE034 has the potential to be developed as a monotherapy and in combination with IDEAYA's PARG inhibitor IDE161 B7H3/PTK7 co-expression in lung, colorectal, and head and neck cancer, has been reported at approximately 30%, 46% and 27%, respectively SOUTH SAN FRANCISCO, Calif. and BEIJING , Nov. 11, 2024 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced the selection of IDE034, a potential first-in-class B7H3/PTK7 topo-I-payload BsADC, as a development candidate and the exercise of its option for an exclusive worldwide license from Biocytogen Pharmaceuticals (Beijing) Co., Ltd.

IDEAYA Announces Development Candidate Nomination of IDE034, a Potential First-in-Class B7H3/PTK7 Topo-I-Payload Bispecific ADC and Option Exercise with Biocytogen

BEIJING & SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- #Antibody--Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, HKEX: 02315), a global biotech company focusing on the discovery of novel antibody/ADC therapeutics, announced that IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, has exercised the option for an exclusive worldwide license for Biocytogen's B7H3/PTK7 BsADC program, IDE034, and has n.

Biocytogen Announces IDEAYA's Nomination of Development Candidate IDE034, a Potential First-in-Class B7H3/PTK7 Topo-I-Payload Bispecific ADC and Option Exercise

The consensus price target hints at an 81.9% upside potential for IDEAYA Biosciences (IDYA). While empirical research shows that this sought-after metric is hardly effective, an upward trend in earnings estimate revisions could mean that the stock will witness an upside in the near term.

Wall Street Analysts Predict an 81.88% Upside in IDEAYA Biosciences (IDYA): Here's What You Should Know

Enrollment in darovasertib + crizotinib 1L HLA-A2+ MUM potential Ph2/3 registration-enabling trial is ahead of schedule and has exceeded 150 patients Successful FDA Type C meeting and targeting initiation of Ph3 registration-enabling trial for darovasertib in neoadjuvant UM in H1 2025; Phase 2 neoadjuvant update with ~49% with > 30% ocular tumor shrinkage & ~61% eyes preserved, and over 75 patients enrolled ENA 2024: Late-breaker oral presentation of IDE397 in MTAP-deletion UC and NSCLC with confirmed ORR by RECIST 1.1 of 40%, 38%, and 22%, in UC, SqNSCLC, and AdenoNSCLC, respectively; co-published IDE397 + AMG 193 preclinical combo data in MTAP-deletion IDE397 + AMG 193 combination study ongoing in MTAP-deletion solid tumors, and targeting expansion in MTAP-deletion NSCLC in late 2024 to early 2025 Targeting expansion of Phase 1/2 study of IDE397 in combination with Trodelvy® in MTAP-deletion UC in Q4 2024, and PR reported at ENA 2024 has confirmed by RECIST 1.1 Targeting Phase 1/2 expansion for IDE161 and FPI in combination with Merck's anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in MSI-High and MSS EC in Q4 2024 IDE705 (GSK 101) Pol Theta Helicase Phase 1 dose escalation ongoing in HRD solid tumors Received IND clearance for IDE275 (GSK959) Werner Helicase development candidate ($7.0 million milestone) for Phase 1 trial in MSI-High solid tumors Targeting Development Candidate nomination for MTAP-deletion, KAT6 pathway and B7H3/PTK7 Topo-Payload Bispecific-ADC programs in Q4 2024 Targeting Investor R&D Day on Monday, December 16, to highlight IDEAYA's preclinical and clinical pipeline with leading KOL(s) and Pharma partner(s) $1.2 billion of cash, cash equivalents and marketable securities as of September 30, 2024, anticipated to fund operations into at least 2028; Completed an oversubscribed ~$302.4 million follow-on financing in July 2024 SOUTH SAN FRANCISCO, Calif. , Nov. 4, 2024 /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, 2024.

IDEAYA Biosciences, Inc. Reports Third Quarter 2024 Financial Results and Provides Business Update

IDEAYA Biosciences (IDYA) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

Earnings Preview: IDEAYA Biosciences, Inc. (IDYA) Q3 Earnings Expected to Decline

IDE275 (GSK959) development is progressing into First-in-Human Phase 1 clinical trial(s) for the treatment of MSI-High solid tumors, representing IDEAYA's 5th potential first-in-class clinical program MSI-High prevalence in endometrial, colorectal, and gastric cancers is ~31%, 20%, and 19%, respectively, highlighting the market potential of IDE275 (GSK959) IDEAYA to receive a $7 million payment for IND acceptance, and potential future aggregate milestones of up to $950 million. IDEAYA has a 50/50 US Profit Share and an 80/20 (GSK/IDEAYA) global research and development cost share SOUTH SAN FRANCISCO, Calif.

IDEAYA Biosciences Announces IND-Clearance for Werner Helicase Development Candidate IDE275 (GSK959) for a Phase 1 Study in MSI-High Solid Tumors

~33% ORR by RECIST 1.1: 1 CR + 8 PRs out of 27 evaluable heavily pre-treated (median 2-3 prior lines, ranging from 1-7) MTAP-deletion UC and NSCLC patients 9 of 9 responses have confirmed by RECIST 1.1 (5 confirmed responses out of 18 evaluable patients reported on July 8, 2024, IDE397 webcast) MTAP-deletion UC: 40% (4 of 10) confirmed ORR and 3 pts on treatment >250 days MTAP-deletion SqNSCLC: ~38% (3 of 8) confirmed ORR and 4 pts on treatment >200 days Multiple PRs with genetic co-alterations, including MTAP-deletion and KRAS G12D mutation in NSCLC, and MTAP-deletion and FGFR-TACC3 fusion in UC Median DOT not yet reached and >6.2 months, and median TTR ~2.7 months ~81% (17 of 21) ctDNA MRR, and high DCR of 93% (25 of 27 with SD or better) AE Profile: No drug-related SAEs or discontinuations at 30 mg once-a-day expansion dose Targeting expansion of Phase 1/2 study of IDE397 in combination with Trodelvy® in MTAP-deletion UC in Q4 2024; patient case study of PR by RECIST 1.1 and rapid >95% ctDNA reduction of combination will be presented at ENA 2024 IDE397 demonstrated deep and durable regressions in combination with PRMT5 inhibitors BMS-986504 and AMG 193 in preclinical models SOUTH SAN FRANCISCO, Calif. , Oct. 25, 2024 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announces Phase 1 expansion data for IDE397 in methylthioadenosine phosphorylase (MTAP)-deletion urothelial cancer (UC) and non-small cell lung cancer (NSCLC) patients as a late breaker abstract (LBA) oral presentation at the 36th edition of the EORTC-NCI-AACR Symposium (ENA 2024) in Barcelona, Spain.

IDEAYA Announces Positive Interim Phase 1 Expansion Data of IDE397 in MTAP-Deletion Urothelial and Lung Cancer as Late-Breaker Oral Presentation at EORTC-NCI-AACR 2024

SOUTH SAN FRANCISCO, Calif. , Oct. 4, 2024 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced a late-breaking oral presentation of the Phase 1 expansion results of IDE397, a first-in-class, oral, MAT2A inhibitor in methylthioadenosine phosphorylase (MTAP)-deletion urothelial and non-small cell lung cancer (NSCLC) patients at the 36th edition of the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics taking place on October 23 to 25, 2024, in Barcelona, Spain.

IDEAYA Biosciences Announces Late-Breaker Oral Presentation of IDE397 Phase 1 Expansion Results in MTAP-Deletion Lung and Urothelial Cancer at the 36th Edition of the EORTC-NCI-AACR Symposium

Ideaya Biosciences Inc.  IDYA, a precision medicine oncology company, released interim Phase 2 clinical trial data.

Ideaya Biosciences Stock Tumbles Despite Promising Data From Rare Eye Cancer Candidate

Phase 2 company-sponsored and IST neoadjuvant uveal melanoma (UM) clinical data update in 49 evaluable patients, demonstrates ~49% of patients with > 30% tumor shrinkage by product of diameters, and ~61% eye preservation rate for enucleation patients Targeting to initiate Phase 3 randomized registrational trial in neoadjuvant UM following finalization of the clinical protocol with FDA Clinical endpoints supportive of full approval based on FDA guidance: Eye preservation rate as the primary endpoint for enucleation patients. Time to vision loss as the primary endpoint for plaque brachytherapy patients.

IDEAYA Biosciences Announces Positive Interim Phase 2 Data for Darovasertib and Successful FDA Type C Meeting on Registrational Trial Design for Regulatory Approval in Neoadjuvant Uveal Melanoma

SOUTH SAN FRANCISCO, Calif. , Sept. 22, 2024 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, today announced that the company plans to issue a pre-market press release and conduct an investor webcast on Monday, September 23, 2024, at 8:00 a.m.

IDEAYA Announces Webcast to Report Interim Phase 2 Data for Darovasertib and Regulatory Update from FDA Type C Meeting in Neoadjuvant Uveal Melanoma on Monday, September 23, 2024

IDEAYA Biosciences uses synthetic lethality to target genetic vulnerabilities in cancer cells, focusing on MTAP-deleted tumors. IDE397 demonstrated promising Phase 2 results with high response rates in MTAP-deleted solid tumors. Strategic partnerships with Pfizer, Amgen, Gilead, and GSK validate IDEAYA's technology and offer substantial potential milestone payments.

Ideaya Biosciences Advances Synthetic Lethality With IDE397 Success

Over 25 years of legal experience with leading healthcare organizations, including GW Pharmaceuticals, Actelion Pharmaceuticals, Eisai, GSK, and the U.S. FDA SOUTH SAN FRANCISCO, Calif. , Sept. 18, 2024 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, today announced that Douglas B.

IDEAYA Biosciences Appoints Douglas B. Snyder as Senior Vice President, General Counsel

SOUTH SAN FRANCISCO, Calif. , Aug. 26, 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 the Morgan Stanley 22nd Annual Global Healthcare Conference.

IDEAYA Biosciences to Participate in the Morgan Stanley 22nd Annual Global Healthcare Conference

Darovasertib achieves triple-digit enrollment in Phase 2/3 trial in 1L HLA-A2*02:01(-) MUM; and >50 patients enrolled in Phase 2 neoadjuvant UM study ASCO 2024 oral presentation of darovasertib in neoadjuvant UM; FDA Type C meeting for neoadjuvant UM in Q3'24 and targeting Phase 2 neoadjuvant UM data update in H2'24 Demonstrated preliminary proof-of-concept for IDE397 in MTAP urothelial and lung cancer; 1 PR awaiting confirmation has confirmed and 1 additional PR still awaiting confirmation, from the 2 uPRs noted in the July 8, 2024 webcast IDEAYA, in consultation with Amgen, has now financially budgeted to support its obligations for target IDE397 / AMG 193 clinical combination expansion in NSCLC Phase 1 FPI achieved for IDE397 and Trodelvy® combo in MTAP-deletion urothelial cancer Targeting initial IDE161 Ph 1/2 expansion and Phase 1 FPI for IDE161 in combination with Merck's anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in endometrial cancer in H2'24 Targeting Werner IND in H2'24, and MTAP and KAT6 pathway DCs in H2'24 Targeting B7H3/PTK7 Topo-Payload Bispecific-ADC DC nomination in H2'24 IDEAYA to host an Investor R&D Day in Q4 2024 $952.7 million of cash, cash equivalents and marketable securities as of June 30, 2024, supplemented by net proceeds of $283.8 million from July 2024 public offering, anticipated to fund operations into at least 2028 SOUTH SAN FRANCISCO, Calif. , Aug. 6, 2024 /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 second quarter ended June 30, 2024.

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