Core Insights - IDEAYA Biosciences (NASDAQ: IDYA) is a developmental biotech company that has generated interesting data but may be overvalued based on previous assessments [1] Company Analysis - The company is involved in the biotech sector, focusing on clinical trials and innovative data generation [1] - The analyst has a background in biochemistry and extensive experience in analyzing biotech companies, indicating a strong foundation for evaluating IDEAYA's potential [1] Market Position - IDEAYA's valuation has been questioned, suggesting that while the company has promising data, its market price may not reflect its actual value [1]

Core Insights - IDEAYA Biosciences announced a successful FDA Type D meeting regarding the Phase 3 trial design for darovasertib as a neoadjuvant therapy for primary uveal melanoma (UM) [1][2] - The trial aims to assess safety and efficacy with primary endpoints focused on eye preservation and vision loss, alongside secondary endpoints related to Event-Free Survival (EFS) [2][6] Company Overview - IDEAYA Biosciences is a precision medicine oncology company dedicated to developing targeted therapeutics through molecular diagnostics [8] - The company integrates capabilities in identifying translational biomarkers with drug discovery to optimize patient selection for its therapies [8] Drug Development Details - Darovasertib is a selective protein kinase C (PKC) inhibitor targeting both primary and metastatic UM [3] - The drug has received Breakthrough Therapy Designation and Fast Track designation from the FDA for its use in neoadjuvant therapy and in combination with crizotinib for metastatic UM [3] Phase 3 Trial Design - The Phase 3 trial is projected to enroll approximately 520 patients, randomized in a 2:1 ratio between darovasertib and control [5][6] - Two cohorts will be included: 120 enucleation-eligible UM patients and 400 plaque brachytherapy (PB) eligible UM patients [5][6] Clinical Endpoints - Primary endpoints include eye preservation rate for enucleation patients and vision loss for PB patients, with no detriment to EFS as a secondary endpoint [6][7] - Additional secondary endpoints will assess overall response rate, macular edema, and vision loss metrics [7] Regulatory Pathway - The company plans to initiate the Phase 3 trial in the first half of 2025, with potential for earlier regulatory submission of enucleation cohort data [4][11]

Core Insights - IDEAYA Biosciences has initiated a Phase 1/2 expansion clinical trial for IDE397, a potential first-in-class MAT2A inhibitor, in combination with Gilead's Trodelvy for treating MTAP-deletion urothelial cancer based on preliminary safety and efficacy data [1][10]. Company Overview - IDEAYA Biosciences is focused on precision medicine in oncology, aiming to discover and develop targeted therapeutics using molecular diagnostics to identify patient populations that would benefit most from its therapies [8]. Clinical Development - The combination of IDE397 and Trodelvy is being explored due to the high unmet medical need in MTAP-deletion urothelial cancer, where no approved therapies currently exist [3]. - The prevalence of MTAP-deletion in urothelial cancer is estimated to be around 26% [2][10]. - A clinical program update regarding the IDE397 and Trodelvy combination is expected in 2025, alongside other studies for IDE397 as a monotherapy in MTAP-deletion non-small cell lung cancer (NSCLC) and urothelial cancer [5]. Collaboration and Rights - IDEAYA and Gilead retain commercial rights to their respective compounds under a clinical study collaboration and supply agreement, with IDEAYA acting as the study sponsor [6].

Recently, I got a complaint from a frustrated reader who pointed out that since my bullish December coverage of Ideaya Biosciences, Inc. (NASDAQ: IDYA ), the stock has gone down relentlessly and is now down ~50%. A numberAbout the TPT serviceThanks for reading. At the Total Pharma Tracker, we offer the following:-Our Android app and website features a set of tools for DIY investors, including a work-in-progress software where you can enter any ticker and get extensive curated research material. For investor ...

Group 1 - IDEAYA Biosciences, Inc. is participating in two upcoming investor relations events, including the 2025 RBCCM Ophthalmology Conference and the Stifel 2025 Virtual Targeted Oncology Forum [1] - The company will have fireside chats featuring its President and CEO Yujiro S. Hata and Chief Medical Officer Darrin Beaupre, hosted by industry analysts [1] - A live audio webcast of these events will be available on the IDEAYA website, with a replay accessible for 30 days post-event [1] Group 2 - IDEAYA is focused on precision medicine in oncology, developing targeted therapeutics based on molecular diagnostics [2] - The company's strategy includes identifying and validating translational biomarkers to select patient populations that are most likely to benefit from its therapies [2] - IDEAYA is particularly engaged in synthetic lethality, which is an emerging area in precision medicine targeting [2]

Core Insights - IDEAYA Biosciences has received FDA Breakthrough Therapy designation for darovasertib, a potential first-in-class PKC inhibitor, aimed at treating adult patients with primary uveal melanoma who are recommended for enucleation [1][2] Group 1: FDA Designation and Clinical Trials - The Breakthrough Therapy designation will facilitate the advancement of darovasertib into a potential Phase 3 registrational trial for primary uveal melanoma [2][6] - The application for BTD was supported by interim clinical data from an ongoing Phase 2 trial, showing an 82% ocular tumor shrinkage rate and a 61% eye preservation rate in patients [4][8] - A Phase 3 registrational study is targeted to be initiated in the first half of 2025, focusing on neoadjuvant darovasertib for patients eligible for enucleation or plaque brachytherapy [5][8] Group 2: Market Potential and Unmet Needs - Neoadjuvant uveal melanoma has an estimated annual incidence of approximately 12,000 patients in North America, Europe, and Australia, representing a significant unmet medical need with no FDA-approved systemic therapies currently available [5][8] - The FDA has also granted Fast Track designation for darovasertib in combination with crizotinib for metastatic uveal melanoma, with an ongoing Phase 2/3 trial [3][4] Group 3: Company Overview and Strategy - IDEAYA Biosciences focuses on precision medicine in oncology, aiming to discover and develop targeted therapeutics using molecular diagnostics [7] - The company integrates capabilities in identifying translational biomarkers with drug discovery to select patient populations most likely to benefit from its therapies [7]

Core Insights - IDEAYA Biosciences announced the publication of abstracts for presentations on IDE275 (GSK959) at the AACR Annual Meeting, highlighting its potential as a best-in-class Werner Helicase inhibitor for treating high microsatellite instability (MSI-H) solid tumors [1][2][3] Company Overview - IDEAYA Biosciences is focused on precision medicine in oncology, developing targeted therapeutics based on molecular diagnostics [9] - The company collaborates with GSK, which is responsible for 80% of the global research and development costs for IDE275 (GSK959) [4] Product Development - IDE275 (GSK959) has shown selective preclinical efficacy in MSI-H solid tumors, with significant prevalence rates of approximately 31% in endometrial, 20% in colorectal, and 19% in gastric cancers [3][7] - The drug is currently in a Phase 1 dose escalation trial in partnership with GSK, with the potential for further clinical development as both a monotherapy and in combination with PD1 inhibitors [2][7] Financial Aspects - IDEAYA could earn a $10 million milestone payment upon the initiation of Phase 1 clinical dose expansion and is eligible for up to $465 million in future milestone payments [4] - Upon commercialization, IDEAYA stands to receive up to $475 million in commercial milestones, 50% of U.S. net profits, and tiered royalties on global non-U.S. net sales of IDE275 [4] Upcoming Presentations - At the AACR 2025, IDEAYA will present a total of 8 presentations across various programs, including 4 focused on IDE275 (GSK959) [5][7]

Core Insights - IDEAYA Biosciences has announced a research collaboration with ATTMOS to develop a physics-based computational small molecule discovery platform targeting undruggable oncology targets [1][2] - The partnership aims to integrate IDEAYA's structural biology and drug discovery capabilities with ATTMOS's computational chemistry and software development expertise [2][3] - The collaboration will utilize the Amber molecular dynamics suite for free energy simulations and aims to enhance the efficiency of drug discovery for novel oncology therapeutics [4] Company Overview - IDEAYA Biosciences focuses on precision medicine in oncology, developing targeted therapeutics based on molecular diagnostics [5] - The company is committed to identifying and validating translational biomarkers to select patient populations that will benefit from its therapies [5] ATTMOS Overview - ATTMOS was founded in early 2022 by a team of academics from Michigan State, Rutgers, and UC San Diego [6] - The company's mission is to integrate novel technologies into the drug discovery process, making them affordable and accessible [6]

Clinical Development Pipeline - The company has a clinical pipeline with six potential first-in-class product candidates, including darovasertib, IDE397, and IDE849, with all commercial rights owned or controlled outside of Greater China for IDE849[21]. - As of February 7, 2025, over 230 patients have been enrolled in the Phase 2/3 clinical trial for darovasertib, targeting a median progression-free survival readout by year-end 2025[25]. - The IDE397 program is being evaluated in a Phase 1/2 clinical trial, with preliminary clinical efficacy demonstrated in heavily pre-treated MTAP-deletion patients[28]. - The company is targeting IND filings for several development candidates, including IDE892 and IDE034, in the second half of 2025[21]. - The company plans to initiate a neoadjuvant UM trial with approximately 400 patients randomized for treatment in the first half of 2025[25]. - The IDE705 program is in Phase 1 dose escalation, targeting solid tumors with BRCA or other HRD mutations, in collaboration with GSK[31]. - The company aims to enable a clinical combination of IDE397 and IDE892 in the second half of 2025 for MTAP-deletion NSCLC[28]. - The company is targeting a clinical data update for darovasertib in over 75 patients in the first half of 2025, including vision data in plaque brachytherapy patients[25]. - IDE849 is currently in a Phase 1 trial in China for small cell lung cancer, with 8 out of 11 evaluable patients achieving partial response[32]. - A U.S. IND submission for IDE849 as a monotherapy in SCLC is planned for the first half of 2025, with a combination evaluation targeted for the second half of 2025[32]. - GSK initiated a Phase 1 clinical trial for IDE275 (GSK959) in October 2024, with a milestone payment of $7.0 million received for IND clearance[32]. - IDE161 is progressing in a Phase 1/2 clinical trial, with an initial expansion dose selected for endometrial cancer and a Phase 1 expansion targeted for 2025[32]. - The company received Fast Track Designations from the FDA for IDE161 in September 2023 for specific advanced cancer treatments[32]. - IDE892, a potential best-in-class MTA-cooperative PRMT5 inhibitor, is targeted for IND submission in mid-2025[36]. - The company has selected IDE034 as a development candidate, with a potential IND submission targeted for the second half of 2025[36]. - Darovasertib (IDE196) has enrolled over 230 patients in a Phase 2/3 trial, with a median overall survival readout targeted for 2025[40]. - The Phase 2 portion of the clinical trial for darovasertib will randomize approximately 230 patients on a 2:1 basis for treatment with darovasertib and crizotinib or control[52]. - The primary endpoint for the Phase 2 trial is median progression-free survival (PFS), with a goal of supporting potential accelerated approval based on efficacy data from approximately 200 patients[52]. - The FDA has granted darovasertib Orphan Drug designation for uveal melanoma (UM) and Fast Track designation for the development program in metastatic uveal melanoma (MUM)[59][60]. - The Phase 2 clinical trial for darovasertib in neoadjuvant UM is projected to enroll approximately 400 patients, with primary endpoints focused on time to vision loss and eye preservation rate[65][66]. - The company has expanded its relationship with Pfizer to support the Phase 2/3 registrational trial, with Pfizer providing crizotinib at no cost for a defined quantity[55]. - The Phase 2 clinical trial for darovasertib as neoadjuvant therapy has enrolled 95 patients as of December 31, 2024, with ongoing enrollment across multiple clinical sites[62]. - The favorable adverse event profile at the 30 mg QD dose of IDE397 showed only 5.6% of patients experienced Grade 3 or higher drug-related adverse events[73]. - The company anticipates initiating the registrational trial for neoadjuvant UM in the first half of 2025, with a targeted move-forward dose of 300 mg BID for darovasertib[67]. - In the Phase 1 expansion data for IDE397, an overall response rate of approximately 33% was reported among 27 evaluable MTAP-deletion patients, with a disease control rate of 93%[74]. - For MTAP-deletion UC patients, the confirmed overall response rate was 40%, while for squamous NSCLC patients it was approximately 38%, and for adenocarcinoma NSCLC patients it was approximately 22%[74]. - The ctDNA minimal response rate was 81%, with 17 of 21 reportable patients showing a 50% or greater ctDNA reduction, and 33% showing a deep 90% or greater ctDNA reduction[74]. - Approximately 18% of patients experienced a Grade 3 or higher drug-related adverse event at the 30 mg QD dose, with no drug-related serious adverse events observed[75]. - The collaboration with Gilead aims to evaluate IDE397 in combination with Trodelvy for MTAP-deletion UC patients, with the first patient dosed in June 2024[76][77]. - The IDE849 program, licensed from Hengrui Pharma, has shown an overall response rate of approximately 73% in SCLC patients, with 8 partial responses observed among 11 evaluable subjects[86]. - IDE161, a PARG inhibitor, is being evaluated in a Phase 1/2 clinical trial for tumors with homologous recombination deficiency, with a focus on endometrial cancer[96][101]. - The IDE161 development program has received Fast Track Designation from the FDA for advanced ovarian and breast cancer patients with BRCA mutations[98][99]. - The company is targeting a Phase 1 expansion for IDE161 in MSI-High and MSS endometrial cancer in 2025[101]. Collaborations and Partnerships - The company has established collaborations with leading pharmaceutical companies, including Pfizer and Gilead, to support clinical development activities[21]. - An exclusive license agreement with Hengrui Pharma for IDE849 includes potential payments totaling $1.045 billion, with a $75 million upfront fee and milestone payments[28]. - The company has expanded its relationship with Pfizer to support the Phase 2/3 registrational trial, with Pfizer providing crizotinib at no cost for a defined quantity[55]. - The company has established strategic partnerships for clinical evaluations, including an exclusive license agreement with Novartis for darovasertib and collaborations with Gilead and Merck for IDE397 and IDE161, respectively[161]. - The company has entered into strategic collaborations with Hengrui Pharma for IDE849 and Biocytogen for IDE034, focusing on selective evaluations of partnerships for targeted product candidates[139]. - The company has formed joint development committees with Pfizer and Gilead to coordinate regulatory and other activities under their respective agreements[168][180]. - The company will bear all internal and external costs associated with the conduct of the combination studies with Gilead and Amgen[179][180]. - The company has a license agreement with Novartis for darovasertib, which includes an upfront payment of $2.5 million and potential milestone payments totaling up to $29 million[176]. - The company entered into a collaboration agreement with GSK, receiving $100 million upfront and being eligible for up to $485 million in development and regulatory milestones for Pol Theta products[192][194]. - The company has the potential to achieve an additional $10.0 million development milestone upon initiation of Phase 1 clinical dose expansion, with further aggregate late-stage development and regulatory milestones of up to $465.0 million[197]. - Under the GSK Collaboration Agreement, the company is eligible to receive total development milestones of up to $485.0 million for each WRN product, along with up to $475.0 million in commercial milestones[199]. - In October 2023, the company earned a $3.0 million milestone from GSK for IND-enabling studies and a $7.0 million milestone for IND clearance of IDE275, with potential for an additional $10.0 million milestone[200]. - The Biocytogen Option and License Agreement includes total potential milestone payments of $400.0 million, with development and regulatory milestones of up to $100.0 million[206]. - The Hengrui Pharma License Agreement includes upfront and milestone payments totaling $1.045 billion, with a $75.0 million upfront fee and up to $200.0 million in development and regulatory milestones[209]. Financial and Regulatory Milestones - The company incurred an obligation to pay milestone payments totaling £750,000 to CRT for achieving specific milestones in the Phase 1 clinical trial of IDE161-001[104]. - The company has the potential to earn up to $10.0 million in milestone payments upon the initiation of Phase 1 clinical dose expansion, with a recent achievement of a $7.0 million milestone based on FDA IND acceptance[111]. - The company is eligible to receive up to $475.0 million in commercial milestones and tiered royalties on global net sales of GSK101, ranging from high single-digit to sub-teen double-digit percentages[112]. - The company is obligated to make milestone payments totaling up to £19.5 million to CRT based on specific development events for PARG inhibitors[188]. Market Position and Competition - The company faces substantial competition from major pharmaceutical and biotechnology companies, with many competitors having significantly greater financial and technical resources[140]. - For darovasertib, the company is not aware of other companies developing clinical-stage therapeutics directed to PKC as a target for solid tumors, indicating a unique position in this area[142]. Intellectual Property - The patent portfolio includes approximately 59 distinct patent families, with 18 issued U.S. patents and 35 pending U.S. applications, protecting technology across the pipeline[154]. - As of January 26, 2025, the PKC program includes approximately six issued U.S. patents and 33 issued foreign patents, with expiration dates ranging from 2035 to 2045[155]. - The MAT2A program has approximately four issued U.S. patents and 50 pending foreign applications, with expiration dates between 2039 and 2044[157]. Research and Development Strategy - The company has established a robust precision medicine research platform, integrating drug discovery with biomarker identification to develop targeted therapies[125]. - The company has established collaborative relationships for access to proprietary databases and genetic screening services, supporting its research and development activities[164]. - The company has various agreements with service providers for research and development activities, including chemistry, compound synthesis, and clinical trial support[165]. - The company plans to selectively evaluate strategic collaborations with biopharmaceutical partners to accelerate development timelines and maximize commercial potential[166]. - In May 2023, the company entered into Amendment No. 4 to the Pfizer Agreement for the supply of crizotinib in support of a Phase 2 clinical trial, with Pfizer providing additional crizotinib at no cost[170]. Manufacturing and Commercialization - The company plans to build its own sales force to commercialize approved medicines in the U.S. and potentially in Europe and other selected countries[212]. - The company currently relies on third parties for the manufacture of product candidates and biomarker diagnostics, with plans to establish agreements with contract manufacturing organizations[213]. - The company intends to retain significant rights in key markets for its products, including worldwide commercialization rights for darovasertib, IDE397, and IDE161[211]. - The GSK Collaboration Agreement will continue until the expiration of payment obligations for each product in each country, unless terminated earlier by either party[203]. - The company has the right to terminate the Biocytogen Option and License Agreement for any reason upon ninety days written notice[207].

Core Viewpoint - IDEAYA Biosciences, Inc. (IDYA) has experienced significant selling pressure, resulting in an 8.6% decline in stock price over the past four weeks, but analysts anticipate improved earnings in the near future [1] Group 1: Stock Performance and Technical Indicators - IDYA's stock is currently in oversold territory, indicated by a Relative Strength Index (RSI) reading of 29.84, suggesting a potential trend reversal [5] - The RSI is a momentum oscillator that helps identify whether a stock is oversold, typically when the reading falls below 30 [2][3] Group 2: Earnings Estimates and Analyst Sentiment - Over the last 30 days, the consensus EPS estimate for IDYA has increased by 1.3%, reflecting a positive trend in earnings estimate revisions [6] - A Zacks Rank of 2 (Buy) places IDYA in the top 20% of over 4,000 ranked stocks, indicating strong potential for a turnaround based on earnings estimate trends [7]