Ideaya Biosciences Receives FDA Review for New Drug Application
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Apr 30 2026
0mins
Should l Buy IDYA?
Ideaya Biosciences announced that the FDA has agreed to review its new drug application for darovasertib in combination with crizotinib for patients with first line HLA A2-negative metastatic uveal melanoma under the Oncology Center of Excellence Real-Time Oncology Review program.
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Analyst Views on IDYA
Wall Street analysts forecast IDYA stock price to rise
15 Analyst Rating
13 Buy
2 Hold
0 Sell
Strong Buy
Current: 28.900
Low
30.00
Averages
49.86
High
79.00
Current: 28.900
Low
30.00
Averages
49.86
High
79.00
About IDYA
IDEAYA Biosciences, Inc. is a medicine oncology company. The Company is engaged in the discovery, development, and commercialization of transformative therapies for cancer. Its product candidates focus on synthetic lethality and antibody-drug conjugates (ADCs) for molecularly defined solid tumor indications. Its product candidates include darovasertib (PKC), IDE397 (MAT2A), IDE849 (DLL3), IDE161 (PARG), IDE275 (Werner Helicase) and IDE705 (Pol Theta Helicase). Darovasertib is a clinical stage, potent and selective small molecule inhibitor of PKC, a protein kinase that functions downstream of the GTPases GNAQ and GNA11. IDE397 is an oral small molecule inhibitor of methionine adenosyl transferase 2a (MAT2A). IDE161 is an oral small molecule poly (ADP-ribose) glycohydrolase (PARG) inhibitor. IDE275 is an oral small molecule inhibitor of the helicase domain of the Werner protein (WRN), a RecQ enzyme involved in the maintenance of genome integrity.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
GT Biopharma Launches Clinical Trial for B7-H3 Targeted Therapy
- Trial Launch: GT Biopharma announced on May 14, 2026, that the first patient has been dosed in its Phase 1 dose-escalation trial of GTB-5550, a therapy targeting B7-H3 in solid tumors, marking a significant advancement in the company's oncology efforts.
- Innovative Targeting Mechanism: GTB-5550 is the third TriKE® molecule from GT Biopharma, utilizing subcutaneous administration to enhance patient convenience, particularly in prostate cancer where B7-H3 is expressed in over 90% of metastatic castration-resistant tumors.
- Market Potential Emerges: The rising interest in B7-H3 as an oncology target is underscored by GT Biopharma's trial progress alongside other companies like Summit Therapeutics and IDEAYA, indicating broad applicability of this target in cancer treatment.
- Strengthened Industry Collaborations: The partnership between Summit Therapeutics and GSK further validates the market value of B7-H3, with the combination study of GSK's antibody drug and Summit's bispecific antibody expected to begin in mid-2026, providing positive signals for investors.
See More
IDEAYA Biosciences Reports Q1 2026 Financial Results and Business Update
- Financial Overview: As of March 31, 2026, IDEAYA reported approximately $972.9 million in cash and cash equivalents, down from $1.05 billion as of December 31, 2025, primarily due to increased net cash used in operations, indicating pressure on the company's financial management.
- Collaboration Revenue Decline: Collaboration revenue for Q1 2026 totaled $6.6 million, significantly down from $10.9 million in Q4 2025, reflecting reduced revenue from R&D services under the exclusive license agreement with Servier, which may impact future cash flow and project progress.
- R&D Expenses Increase: R&D expenses reached $95.7 million in Q1 2026, up from $86.6 million in Q4 2025, driven by higher clinical trial and personnel-related costs, indicating the company's ongoing investment in advancing its product pipeline.
- Widening Net Loss: The net loss for Q1 2026 was $98.5 million, compared to a loss of $83.3 million in Q4 2025, reflecting high costs associated with expanding R&D and market preparation, which could negatively affect investor confidence.
See More
IDEAYA Grants Stock Options to New Employees
- Stock Option Grant: On April 30, 2026, IDEAYA granted 237,800 non-qualified stock options to five new employees, aimed at attracting top talent and strengthening the team.
- Incentive Plan Context: The grant is made under the 2023 Employment Inducement Incentive Award Plan, complying with Nasdaq Listing Rule 5635(c)(4), specifically designed to attract individuals who were not previously employed by IDEAYA.
- Option Exercise Price: The stock options have an exercise price of $29.10 per share, equal to the closing price of IDEAYA's common stock on the grant date, ensuring alignment of employee interests with company stock performance.
- Vesting Arrangement: The options will vest over four years, with 25% vesting on the first anniversary and the remaining 75% vesting in equal monthly installments, incentivizing continued employee service and contribution to the company.
See More
IDEAYA Grants 237,800 Stock Options to New Employees
- Stock Option Grant: On April 30, 2026, IDEAYA granted 237,800 non-qualified stock options to five new employees, aimed at attracting top talent and strengthening the team.
- Incentive Plan Context: These stock options were awarded under IDEAYA's 2023 Employment Inducement Incentive Award Plan, complying with Nasdaq Listing Rule 5635(c)(4), specifically designed to incentivize new hires.
- Exercise Price and Term: The options have an exercise price of $29.10 per share, matching the closing price on the grant date, with a 10-year term and a four-year vesting schedule, enhancing long-term employee motivation.
- Service Requirement: The vesting of the stock options is contingent upon the employee's continued service on each vesting date, ensuring a commitment to the company and promoting stability in its growth.
See More
IDEAYA Biosciences to Present Key Data at ASCO Meeting
- Clinical Trial Data Release: IDEAYA Biosciences will present complete data from the Phase 2/3 registrational trial of darovasertib in combination with crizotinib for HLA*A2-negative metastatic uveal melanoma at the 2026 ASCO Annual Meeting, which is expected to significantly impact the clinical application prospects of this drug.
- Presentation Schedule: The company will deliver an oral presentation on June 1, 2026, from 8-11 AM CDT in Chicago, showcasing additional data not disclosed in the topline release, potentially providing clinicians with deeper insights into treatment options.
- Significance of Findings: The presentation will be led by Dr. Marlana Orloff, Associate Professor of Medical Oncology at Thomas Jefferson University Hospital, emphasizing the potential breakthroughs of this study in treating metastatic uveal melanoma, which could change existing treatment standards.
- Strategic Positioning: IDEAYA is committed to the development of precision medicine, focusing on a pipeline of synthetic lethality and antibody-drug conjugates, showcasing its innovative capabilities and market competitiveness in cancer treatment, further solidifying its industry leadership.
See More
IDEAYA Biosciences Announces Key Clinical Data Presentation
- Clinical Data Presentation: IDEAYA Biosciences will present complete data from the Phase 2/3 registrational trial of darovasertib in combination with crizotinib for HLA*A2-negative metastatic uveal melanoma at the 2026 ASCO Annual Meeting, which is expected to significantly impact treatment options in this field.
- Presentation Schedule: Scheduled for June 1, 2026, from 8-11 AM CDT, the presentation will be led by Dr. Marlana Orloff, Associate Professor of Medical Oncology at Thomas Jefferson University Hospital, and will include additional data not disclosed in the company's topline release, potentially providing new insights for clinical practice.
- Company Mission and Vision: IDEAYA is committed to developing transformative therapies for cancer, integrating expertise in small-molecule drug discovery, structural biology, and bioinformatics to change disease progression through precision medicine, showcasing strong market potential.
- Forward-Looking Statements: The press release includes forward-looking statements regarding the clinical development and therapeutic potential of darovasertib, highlighting uncertainties and risks inherent in the drug development process, which investors should consider for informed decision-making.
See More
GT Biopharma Launches Clinical Trial for B7-H3 Targeted Therapy
- Trial Launch: GT Biopharma announced on May 14, 2026, that the first patient has been dosed in its Phase 1 dose-escalation trial of GTB-5550, a therapy targeting B7-H3 in solid tumors, marking a significant advancement in the company's oncology efforts.
- Innovative Targeting Mechanism: GTB-5550 is the third TriKE® molecule from GT Biopharma, utilizing subcutaneous administration to enhance patient convenience, particularly in prostate cancer where B7-H3 is expressed in over 90% of metastatic castration-resistant tumors.
- Market Potential Emerges: The rising interest in B7-H3 as an oncology target is underscored by GT Biopharma's trial progress alongside other companies like Summit Therapeutics and IDEAYA, indicating broad applicability of this target in cancer treatment.
- Strengthened Industry Collaborations: The partnership between Summit Therapeutics and GSK further validates the market value of B7-H3, with the combination study of GSK's antibody drug and Summit's bispecific antibody expected to begin in mid-2026, providing positive signals for investors.
See More
IDEAYA Biosciences Reports Q1 2026 Financial Results and Business Update
- Financial Overview: As of March 31, 2026, IDEAYA reported approximately $972.9 million in cash and cash equivalents, down from $1.05 billion as of December 31, 2025, primarily due to increased net cash used in operations, indicating pressure on the company's financial management.
- Collaboration Revenue Decline: Collaboration revenue for Q1 2026 totaled $6.6 million, significantly down from $10.9 million in Q4 2025, reflecting reduced revenue from R&D services under the exclusive license agreement with Servier, which may impact future cash flow and project progress.
- R&D Expenses Increase: R&D expenses reached $95.7 million in Q1 2026, up from $86.6 million in Q4 2025, driven by higher clinical trial and personnel-related costs, indicating the company's ongoing investment in advancing its product pipeline.
- Widening Net Loss: The net loss for Q1 2026 was $98.5 million, compared to a loss of $83.3 million in Q4 2025, reflecting high costs associated with expanding R&D and market preparation, which could negatively affect investor confidence.
See More
IDEAYA Grants Stock Options to New Employees
- Stock Option Grant: On April 30, 2026, IDEAYA granted 237,800 non-qualified stock options to five new employees, aimed at attracting top talent and strengthening the team.
- Incentive Plan Context: The grant is made under the 2023 Employment Inducement Incentive Award Plan, complying with Nasdaq Listing Rule 5635(c)(4), specifically designed to attract individuals who were not previously employed by IDEAYA.
- Option Exercise Price: The stock options have an exercise price of $29.10 per share, equal to the closing price of IDEAYA's common stock on the grant date, ensuring alignment of employee interests with company stock performance.
- Vesting Arrangement: The options will vest over four years, with 25% vesting on the first anniversary and the remaining 75% vesting in equal monthly installments, incentivizing continued employee service and contribution to the company.
See More
IDEAYA Grants 237,800 Stock Options to New Employees
- Stock Option Grant: On April 30, 2026, IDEAYA granted 237,800 non-qualified stock options to five new employees, aimed at attracting top talent and strengthening the team.
- Incentive Plan Context: These stock options were awarded under IDEAYA's 2023 Employment Inducement Incentive Award Plan, complying with Nasdaq Listing Rule 5635(c)(4), specifically designed to incentivize new hires.
- Exercise Price and Term: The options have an exercise price of $29.10 per share, matching the closing price on the grant date, with a 10-year term and a four-year vesting schedule, enhancing long-term employee motivation.
- Service Requirement: The vesting of the stock options is contingent upon the employee's continued service on each vesting date, ensuring a commitment to the company and promoting stability in its growth.
See More
IDEAYA Biosciences to Present Key Data at ASCO Meeting
- Clinical Trial Data Release: IDEAYA Biosciences will present complete data from the Phase 2/3 registrational trial of darovasertib in combination with crizotinib for HLA*A2-negative metastatic uveal melanoma at the 2026 ASCO Annual Meeting, which is expected to significantly impact the clinical application prospects of this drug.
- Presentation Schedule: The company will deliver an oral presentation on June 1, 2026, from 8-11 AM CDT in Chicago, showcasing additional data not disclosed in the topline release, potentially providing clinicians with deeper insights into treatment options.
- Significance of Findings: The presentation will be led by Dr. Marlana Orloff, Associate Professor of Medical Oncology at Thomas Jefferson University Hospital, emphasizing the potential breakthroughs of this study in treating metastatic uveal melanoma, which could change existing treatment standards.
- Strategic Positioning: IDEAYA is committed to the development of precision medicine, focusing on a pipeline of synthetic lethality and antibody-drug conjugates, showcasing its innovative capabilities and market competitiveness in cancer treatment, further solidifying its industry leadership.
See More
IDEAYA Biosciences Announces Key Clinical Data Presentation
- Clinical Data Presentation: IDEAYA Biosciences will present complete data from the Phase 2/3 registrational trial of darovasertib in combination with crizotinib for HLA*A2-negative metastatic uveal melanoma at the 2026 ASCO Annual Meeting, which is expected to significantly impact treatment options in this field.
- Presentation Schedule: Scheduled for June 1, 2026, from 8-11 AM CDT, the presentation will be led by Dr. Marlana Orloff, Associate Professor of Medical Oncology at Thomas Jefferson University Hospital, and will include additional data not disclosed in the company's topline release, potentially providing new insights for clinical practice.
- Company Mission and Vision: IDEAYA is committed to developing transformative therapies for cancer, integrating expertise in small-molecule drug discovery, structural biology, and bioinformatics to change disease progression through precision medicine, showcasing strong market potential.
- Forward-Looking Statements: The press release includes forward-looking statements regarding the clinical development and therapeutic potential of darovasertib, highlighting uncertainties and risks inherent in the drug development process, which investors should consider for informed decision-making.
See More
