IDEAYA Biosciences, Inc. (IDYA): Análisis PESTLE [Actualizado en Ene-2025]

En el panorama dinámico de la oncología de precisión, Ideeya Biosciences, Inc. (Idya) está a la vanguardia de la innovadora investigación del cáncer, navegando por un complejo ecosistema de desafíos políticos, económicos, sociológicos, tecnológicos, legales y ambientales. Este análisis integral de mano presenta la intrincada red de factores que influyen en la trayectoria estratégica de la compañía, ofreciendo una exploración matizada de cómo las fuerzas externas dan forma al futuro de las terapias innovadoras del cáncer. Desde tecnologías genómicas de vanguardia hasta paisajes regulatorios y demandas sociales, el viaje de Ideeya representa una intersección crítica de la ambición científica e influencias ambientales multifacéticas que podrían revolucionar los paradigmas del tratamiento del cáncer.

Ideya Biosciences, Inc. (Idya) - Análisis de mortero: factores políticos

Financiación federal de los Estados Unidos y otorga apoyo para la investigación de biotecnología y oncología de precisión

En 2023, los Institutos Nacionales de Salud (NIH) asignaron $ 47.1 mil millones para la investigación médica, con aproximadamente $ 6.9 mil millones Dirigido específicamente a la financiación de la investigación del cáncer.

Fuente de financiación	Asignación 2023
NIH Presupuesto total	$ 47.1 mil millones
Financiación de la investigación del cáncer	$ 6.9 mil millones
Investigación de oncología de precisión	$ 1.2 mil millones

Cambios de políticas potenciales en la atención médica y regulaciones farmacéuticas

El panorama regulatorio actual indica posibles cambios de política que afectan a las compañías de biotecnología:

• Modificaciones del proceso de designación de terapia de la FDA
• Cambios potenciales en las regulaciones de precios de drogas
• Requisitos de transparencia de ensayos clínicos mejorados

Prioridades de investigación del Instituto Nacional de Salud (NIH)

Área de prioridad de investigación	Asignación de financiación 2024
Medicina de precisión	$ 2.4 mil millones
Investigación oncológica	$ 1.7 mil millones
Investigación genómica	$ 1.3 mil millones

Posibles cambios en las políticas de investigación y financiamiento del tratamiento del cáncer

Los indicadores clave de la política para 2024 incluyen:

• Mayor enfoque en las terapias personalizadas del cáncer
• Aumento potencial del 7,2% en la financiación federal de investigación del cáncer
• Soporte ampliado para iniciativas de oncología de precisión

La iniciativa de cáncer de la administración de Biden continúa priorizando $ 1.8 mil millones en fondos de investigación de cáncer dirigido hasta 2028.

Ideeya Biosciences, Inc. (Idya) - Análisis de mortero: factores económicos

Volátiles de inversión en biotecnología y mercados de capital de riesgo

A partir del cuarto trimestre de 2023, Ideeya Biosciences experimentó una dinámica financiera significativa en el panorama de inversiones de biotecnología:

Métrico de inversión	Valor	Año
Financiación total de capital de riesgo	$ 86.7 millones	2023
Financiación de colocación privada	$ 75.2 millones	2023
Efectivo e inversiones	$ 226.4 millones	P3 2023

Fluctuante del rendimiento del stock del sector de la salud

El rendimiento de las acciones de Ideeya Biosciences (IDYA) refleja tendencias más amplias del mercado:

Métrica de rendimiento de stock	Valor	Período
Rango de precios de las acciones	$6.87 - $12.45	2023
Capitalización de mercado	$ 394.6 millones	Diciembre de 2023
Promedio de volumen comercial	387,000 acciones	P4 2023

Desafíos de los costos de investigación y desarrollo

Gastos de I + D de IDEYA's Precision Oncology:

Categoría de gastos de I + D	Cantidad	Año
Gastos totales de I + D	$ 64.3 millones	2023
Costos de ensayo clínico	$ 42.1 millones	2023
Investigación preclínica	$ 22.2 millones	2023

El impacto de los ciclos económicos en la financiación de la investigación de biotecnología

Fuentes de financiación y asignaciones para IdeaYa:

Fuente de financiación	Cantidad	Año
Subvenciones del gobierno	$ 5.6 millones	2023
Asociaciones estratégicas	$ 18.9 millones	2023
Inversiones institucionales	$ 52.3 millones	2023

Ideeya Biosciences, Inc. (Idya) - Análisis de mortero: factores sociales

Creciente conciencia pública y demanda de tratamientos personalizados contra el cáncer

Según el Instituto Nacional del Cáncer, se proyecta que el mercado de medicina personalizada para los tratamientos contra el cáncer alcanzará los $ 186.7 mil millones para 2027, con una tasa compuesta anual del 11.4%.

Año	Tamaño del mercado personalizado del tratamiento del tratamiento del cáncer	Tasa de crecimiento anual
2024	$ 127.5 mil millones	10.2%
2027 (proyectado)	$ 186.7 mil millones	11.4%

Aumento del enfoque en las pruebas genéticas y la medicina de precisión

Se espera que el mercado global de pruebas genéticas alcance los $ 31.8 mil millones para 2027, con la oncología que representa el 35% de la participación total de mercado.

Segmento del mercado de pruebas genéticas	Valor de mercado 2024	Valor de mercado proyectado 2027
Oncología prueba genética	$ 11.2 mil millones	$ 16.5 mil millones
Mercado total de pruebas genéticas	$ 22.6 mil millones	$ 31.8 mil millones

El envejecimiento de la población que impulsa la demanda de tratamientos de oncología avanzada

Para 2024, los individuos mayores de 65 años representan el 16,9% de la población de EE. UU., Con tasas de incidencia de cáncer que aumentan el 28,4% en este grupo demográfico.

Grupo de edad	Porcentaje de población	Tasa de incidencia de cáncer
65 años o más	16.9%	28.4%

Grupos de defensa del paciente que influyen en las prioridades de investigación

Las organizaciones clave de defensa del cáncer invirtieron $ 687 millones en fondos de investigación en 2024, con medicina de precisión que recibe el 42% de la asignación total.

Área de enfoque de investigación	Asignación de financiación	Porcentaje de total
Medicina de precisión	$ 288.5 millones	42%
Otras áreas de investigación	$ 398.5 millones	58%

Ideeya Biosciences, Inc. (Idya) - Análisis de mortero: factores tecnológicos

Secuenciación genómica avanzada y tecnologías de perfiles moleculares

Ideeya Biosciences ha invertido $ 12.4 millones en tecnologías de secuenciación genómica a partir del cuarto trimestre de 2023. La compañía utiliza plataformas de secuenciación de próxima generación con una capacidad de rendimiento de 18,000 secuencias de genoma por año.

Plataforma tecnológica	Inversión ($ m)	Capacidad anual
Illumina Novaseq x	5.7	10,000 genomas
Secuela de Pacbio II	4.2	5,000 genomas
Prometión de nanoporo de Oxford	2.5	3.000 genomas

Inteligencia artificial y aprendizaje automático en la investigación del cáncer

Ideeya ha asignado $ 8.6 millones para la infraestructura de investigación de IA y Aprendizaje Machine en 2023. Los recursos computacionales incluyen 240 grupos de GPU diseñados específicamente para algoritmos de investigación del cáncer.

Tecnología de IA	Potencia computacional	Enfoque de investigación
Plataforma de DeepGenomics	72 NVIDIA A100 GPU	Modelado de oncología predictiva
Google Cloud AI	120 núcleos TPU	Optimización del descubrimiento de drogas
IBM Watson Oncology	48 grupos de CPU	Predicción de respuesta al tratamiento

CRISPR y tecnologías de edición de genes para terapias dirigidas

Ideeya ha comprometido $ 15.3 millones al desarrollo de la tecnología CRISPR, con 7 programas de investigación de edición de genes activos dirigidos a mutaciones de cáncer específicas.

Tecnología CRISPR	Inversión ($ m)	Mutaciones objetivo
Plataforma de terapéutica CRISPR	6.2	Mutaciones BRCA1/2
Sistema de genómica de vértices	5.1	alteraciones del gen p53
Caribou Biosciences	4.0	Mutaciones de la ruta Ras

Plataformas emergentes de biología computacional y bioinformática

Ideeya ha invertido $ 6.9 millones en infraestructura bioinformática avanzada, que respalda 22 proyectos de investigación de biología computacional en 2023.

Plataforma bioinformática	Inversión ($ m)	Proyectos de investigación
Plataformas del Instituto Broad	2.8	10 proyectos de análisis genómico
Biología computacional de Stanford	2.1	7 Estudios de medicina de precisión
Sistemas computacionales del MIT	2.0	5 Iniciativas de aprendizaje automático

Ideeya Biosciences, Inc. (Idya) - Análisis de mortero: factores legales

Procesos de aprobación regulatoria de la FDA para terapias contra el cáncer

A partir de 2024, Ideeya Biosciences enfrenta requisitos regulatorios de la FDA complejos para las terapias contra el cáncer. La tubería de desarrollo de medicamentos de la compañía requiere documentación integral de ensayos clínicos y evaluaciones de seguridad rigurosas.

Métrica reguladora de la FDA	Datos específicos
Tiempo promedio de revisión de la FDA para drogas oncológicas	10.4 meses
Probabilidad de aprobación de la FDA para drogas oncológicas	5.9%
Se requieren fases de ensayos clínicos	3 fases
Duración típica del ensayo clínico	6-7 años

Protección de propiedad intelectual para nuevos enfoques terapéuticos

La estrategia de propiedad intelectual de Ideeya implica protección integral de patentes para sus tecnologías de oncología de precisión.

Parámetro de protección de IP	Datos específicos
Número de patentes activas	12
Costo de solicitud de patente	$ 15,000- $ 25,000 por solicitud
Mantenimiento de patentes Costo anual	$ 4,500 por patente
Duración de protección de patentes	20 años desde la fecha de presentación

Cumplimiento de las regulaciones de ensayos clínicos y los estándares de seguridad del paciente

Los requisitos clave de cumplimiento incluyen la adherencia a las buenas pautas de práctica clínica (PCG) y protocolos integrales de consentimiento del paciente.

• Requisitos de envío del Formulario 1572 de la FDA
• Aprobaciones de la Junta de Revisión Institucional (IRB)
• Informes de eventos adversos integrales
• Protección de la privacidad de datos del paciente

Paisaje de patentes y posibles litigios en oncología de precisión

Ideeya navega por un complejo panorama de patentes con posibles riesgos de litigios en la investigación de oncología de precisión.

Parámetro de litigio	Datos específicos
Costo de litigio de patente promedio	$ 1.5 millones a $ 3 millones
Duración típica de la demanda de infracción de patentes	2-3 años
Tasa de éxito en defensa de patentes	62%
Presupuesto anual de litigios de IP	$500,000

Ideeya Biosciences, Inc. (Idya) - Análisis de mortero: factores ambientales

Prácticas de laboratorio sostenibles y protocolos de investigación

Ideeya Biosciences informa un 14.2% de reducción En el consumo total de energía en las instalaciones de investigación en 2023. La Compañía implementó programas de certificación de laboratorio verde con una inversión de $ 1.3 millones en mejoras de infraestructura sostenible.

Métrica de sostenibilidad	2023 rendimiento	Inversión
Eficiencia energética	14.2% de reducción	$ 1.3 millones
Conservación del agua	22.5% Reducción	$875,000
Minimización de desechos	18.7% disminución	$650,000

Reducción de la huella de carbono en la investigación de biotecnología

IDEYA informó un Reducción de emisiones de carbono de 127.4 toneladas métricas CO2 equivalente en 2023, que representa una disminución del 16.3% desde la línea de base del año anterior.

Categoría de emisiones de carbono	2023 emisiones (toneladas métricas CO2)	Porcentaje de reducción
Alcance 1 emisiones	42.6	12.5%
Alcance 2 emisiones	84.8	19.2%

Consideraciones éticas en la investigación genética y el desarrollo de la terapia

Ideeya asignado $ 2.7 millones Hacia los procesos de revisión ética y los mecanismos de cumplimiento en la investigación genética durante 2023.

Gestión de residuos e impacto ambiental de la investigación farmacéutica

La compañía implementó protocolos integrales de gestión de residuos, logrando 92.6% de reciclaje de residuos peligrosos en 2023 con un gasto total de gestión de residuos de $ 1.1 millones.

Categoría de gestión de residuos	Volumen total (kg)	Tasa de reciclaje
Residuos de laboratorio peligrosos	8,750	92.6%
Desechos biológicos	3,425	88.3%
Desechos químicos	5,210	95.1%

IDEAYA Biosciences, Inc. (IDYA) - PESTLE Analysis: Social factors

Core focus on precision oncology addresses high-need, genetically-defined solid tumors like MTAP-deletion cancers

IDEAYA Biosciences' entire business model is built on precision oncology, which is a major societal trend toward more effective, less toxic cancer treatments. The core of this strategy is synthetic lethality (a therapeutic approach where two non-lethal gene defects are combined to kill a cell), targeting specific genetic vulnerabilities in tumors. This approach directly addresses the high unmet medical need in genetically-defined solid tumors, particularly those with the methylthioadenosine phosphorylase (MTAP) gene deletion.

This MTAP-deletion is a significant, high-prevalence biomarker, meaning it's found in a large number of cancer patients. The deletion is estimated to occur in approximately 15% of all solid tumors. For IDEAYA's lead program in this area, IDE397, the target patient population is substantial. Here's the quick math on the need in the U.S. alone:

Cancer Type	MTAP-Deletion Prevalence	Estimated U.S. Annual Incidence (MTAP-Deleted Patients)
Urothelial Cancer (UC)	~26%	Included in ~48,000 patients
Non-Small Cell Lung Cancer (NSCLC)	Up to 20%	Included in ~48,000 patients
Pancreatic Cancer	>20%	Approximately 14,000 patients

Addressing this patient group with a targeted therapy like IDE397 (a MAT2A inhibitor) immediately positions the company as a leader in a critical area of personalized medicine. That's a massive, underserved patient population.

The company's mission aligns with the societal push for more selective and personalized cancer therapies

The company's stated mission-to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized-is defintely in sync with the public and medical community's desire for better cancer care. This focus on biomarker-defined patient populations means they are not developing a drug for a broad, heterogeneous group, but rather a tailored solution for a specific genetic driver of disease.

This personalized approach is what drives patient advocacy and physician buy-in. It helps, rather than hinders, the regulatory process because the clinical trials focus on patients most likely to respond. This is the future of oncology, and IDEAYA is positioned right at the center of it.

• Integrates structural biology and bioinformatics.
• Develops tailored, potentially first-in-class targeted therapies.
• Goal is altering the course of disease and improving clinical outcomes.

Success in rare cancers, like metastatic uveal melanoma (mUM), builds strong key opinion leader (KOL) support

Success in a rare, aggressive cancer like metastatic uveal melanoma (mUM) generates outsized positive social and professional momentum. The darovasertib and crizotinib combination therapy has delivered results that are highly impactful in a disease with historically poor prognosis. This builds strong key opinion leader (KOL) support because it offers a meaningful, new option where few existed.

Clinical data from the Phase 2 OptimUM-01 trial, presented in late 2025, showed a median overall survival (OS) of 21.1 months in 44 first-line mUM patients. This is a huge win, considering the historical median OS reported in published meta-analyses for this rare cancer is approximately 12 months. That's nearly a year of extra life for a patient population with limited options. The confirmed overall response rate (ORR) was 34% with a disease control rate (DCR) of 90%.

Public perception is largely positive due to the therapeutic area (oncology) and precision medicine approach

Public perception is overwhelmingly positive because the company is working on cancer, a universally high-priority therapeutic area, and their method is targeted and innovative. The focus on synthetic lethality is viewed as cutting-edge science. The positive sentiment is reinforced by key regulatory milestones in 2025.

For example, the single-agent darovasertib program for neoadjuvant treatment of primary uveal melanoma received U.S. FDA Breakthrough Therapy Designation in 2025. This designation is a clear signal from the FDA that the therapy may offer a substantial improvement over existing options, which translates into immediate, positive perception among physicians, patients, and investors. Wall Street analysts also reflect this optimism, with price targets ranging from $27 to $74 per share in late 2025. This financial confidence underscores the belief in the societal value of their pipeline.

IDEAYA Biosciences, Inc. (IDYA) - PESTLE Analysis: Technological factors

IDEAYA Biosciences, Inc.'s technological strength is centered on its precision oncology platform, which is built on two highly advanced modalities: synthetic lethality and next-generation Antibody-Drug Conjugates (ADCs). This dual focus, coupled with a sophisticated computational discovery engine, allows them to pursue oncology targets that were defintely considered undruggable just a few years ago.

The company is not just developing new drugs; they are using technology to fundamentally redefine the drug discovery process, which is why their pipeline is moving so quickly. They are using their internal structural biology and bioinformatics capabilities to select patient populations most likely to benefit, translating directly into higher probability of clinical success.

Deep pipeline based on synthetic lethality and Antibody-Drug Conjugates (ADCs), including bispecifics

The core of IDEAYA's technology lies in its leadership in synthetic lethality (SL) and its strategic entry into the Antibody-Drug Conjugate (ADC) space, which includes advanced bispecific formats. Synthetic lethality is a concept where the simultaneous inhibition of two genes or proteins is lethal to a cancer cell, but the inhibition of either one alone is not. This allows for highly selective targeting of tumor-specific vulnerabilities.

Their pipeline features multiple potential first-in-class assets across these two platforms. The focus remains on molecularly defined solid tumor indications, meaning they use a patient's genetic profile to tailor the therapy. This is precision medicine in action.

Program / Technology	Mechanism / Target	Development Status (as of 4Q 2025)	Technological Significance
Darovasertib	PKC inhibitor (Synthetic Lethality)	Phase 2/3 (OptimUM-02) in mUM	Lead program validating the SL approach in a difficult-to-treat cancer.
IDE397	MAT2A inhibitor (Synthetic Lethality)	Phase 1/2 (Combo with Trodelvy®)	Targeting MTAP-deleted cancers, a prevalent genetic alteration in up to 15-20% of NSCLC.
IDE849	DLL3 TOP1i ADC	Phase 1 (SCLC)	A Topoisomerase 1 inhibitor (TOP1i) payload ADC, showing high Overall Response Rates (ORRs) in early SCLC data.
IDE034	B7H3/PTK7 Bispecific TOP1i ADC	IND Filing Complete (4Q 2025)	Potential first-in-class bispecific ADC, targeting two antigens simultaneously for enhanced tumor selectivity and efficacy.

Clinical data readouts for multiple programs are expected by year-end 2025/1Q 2026, creating near-term catalysts

For a biotech firm, clinical data readouts are the clearest near-term catalysts, and IDEAYA has a significant one on the horizon. The Phase 2/3 OptimUM-02 trial evaluating the darovasertib/crizotinib combination in first-line (1L) HLA-A2-negative metastatic uveal melanoma (mUM) is on track to report median Progression-Free Survival (PFS) data between year-end 2025 and 1Q 2026. This is a huge milestone.

A positive readout here has the potential to enable an accelerated approval filing in the United States. To put the impact in perspective, the single-arm Phase 2 trial (OptimUM-01) already demonstrated a median Overall Survival (OS) of 21.1 months and a median PFS of 7.0 months in 1L mUM patients, with a confirmed Overall Response Rate (ORR) of 34%. These numbers set a high bar for the registrational trial.

Uses bioinformatics and AI/ML-based discovery to identify and validate translational biomarkers

IDEAYA's technological edge starts well before the clinic, specifically in the discovery phase. They integrate expertise in structural biology and bioinformatics with strong internal capabilities for identifying and validating translational biomarkers.

More recently, they have expanded their computational drug discovery efforts through a collaboration with ATTMOS, focusing on a physics-based computational small molecule discovery platform. This platform aims to use AI/ML (Artificial Intelligence/Machine Learning) to rapidly unlock targets currently perceived as undruggable. This shift from traditional screening to high-performance computing and statistical mechanics is a forward-looking move to maintain a first-in-class pipeline.

Three new Investigational New Drug (IND) filings targeted in 2025 (IDE892, IDE034, IDE574) show rapid pipeline advancement

The pace of new drug candidate translation into the clinic is a key measure of a biotech's technological productivity. IDEAYA targeted three new Investigational New Drug (IND) applications in the 2025 fiscal year, demonstrating rapid pipeline advancement. This is a strong sign of their discovery engine's efficiency.

Here's the quick math on their recent regulatory progress:

• IDE892: IND clearance for this potential best-in-class PRMT5 inhibitor was received in 3Q 2025. The company is targeting the first patient dosing in a Phase 1 trial in 4Q 2025.
• IDE034: The IND filing for this B7H3/PTK7 bispecific TOP1i ADC was complete in 4Q 2025.
• IDE574: The IND filing for this potential first-in-class KAT6/7 dual inhibitor is on track for year-end 2025.

Advancing three novel candidates from preclinical to clinical-stage in a single year, especially with two of them being first-in-class and one a complex bispecific ADC, underscores the technological maturity of their platform.

IDEAYA Biosciences, Inc. (IDYA) - PESTLE Analysis: Legal factors

The legal landscape for IDEAYA Biosciences is complex and rapidly evolving in 2025, driven by a dense network of global licensing deals and the high-stakes regulatory path for its lead asset, darovasertib. Your primary legal risk isn't litigation; it's the intricate management of intellectual property (IP) rights across multiple continents and partners, plus the intense scrutiny of registrational trials.

Extensive network of collaboration and license agreements with major pharma requires complex IP management.

IDEAYA's strategy of partnering to validate its platforms and fund development creates a web of legal obligations. These agreements, while financially beneficial, require meticulous contract and IP management to prevent disputes and ensure compliance with territorial rights and development milestones. This is defintely a high-touch legal area.

For example, the company has a 'Clinical Study Collaboration and Supply Agreement' with Gilead Sciences, Inc. and an 'Amendment No. 5 to Clinical Trial Collaboration and Supply Agreement' with Pfizer Inc. in 2025, which dictates the supply and use of their respective drugs in combination trials. Furthermore, the strategic partnership with GlaxoSmithKline (GSK) on the Synthetic Lethality (SL) platform programs, Pol Theta and Werner Helicase, includes a 50% US profit-share for Werner Helicase and worldwide royalties for Pol Theta, setting up a long-term, legally-defined revenue-sharing structure.

Here's the quick math on recent collaboration cash inflows, which legally trigger future performance obligations:

Partner	Program/Platform	Upfront Payment (2025)	Potential Milestones
Servier	Darovasertib (PKC inhibitor)	$210 million	Up to $320 million
Jiangsu Hengrui Pharma	IDE849 (DLL3 ADC)	$75 million	Not specified in search results

Must maintain and defend intellectual property (IP) for its synthetic lethality and ADC platforms globally.

The company's valuation is fundamentally tied to its intellectual property (IP), particularly for its synthetic lethality (SL) programs-like IDE397 (MAT2A inhibitor) and IDE161 (PARG inhibitor)-and its emerging Antibody-Drug Conjugate (ADC) pipeline. The legal requirement isn't just to file patents, but to actively monitor and defend them against infringement across all major pharmaceutical markets, which is a costly and continuous process.

The complexity is magnified because the core technology is licensed, like the option for a bispecific ADC program (IDE034) from Biocytogen, which adds another layer of legal dependency and IP co-management. The legal team must constantly assess the IP landscape to ensure freedom-to-operate and enforce their exclusivity. What this estimate hides is the true cost of a major patent infringement lawsuit, which can easily run into the tens of millions of dollars.

The Servier agreement legally defines the US-only commercial rights for darovasertib retained by IDEAYA Biosciences.

The September 2025 exclusive license agreement with Servier for the PKC inhibitor darovasertib is a pivotal legal document that clearly delineates the company's future commercial strategy. This legal structure is crucial for investors because it confirms IDEAYA's commitment to building a US commercial infrastructure for its lead product.

The key legal stipulations are precise:

• IDEAYA retains all regulatory and commercial rights for darovasertib in the United States.
• Servier obtains the exclusive regulatory and commercial rights in all territories outside the United States.
• IDEAYA is eligible for double-digit royalties on net sales of darovasertib in Servier's ex-US territories.

This structure means all US commercialization risks and opportunities fall solely on IDEAYA, while the ex-US market is legally Servier's responsibility, generating a royalty stream for IDEAYA.

Regulatory compliance risk is high, typical for a biotech moving toward commercialization with a registrational trial.

As IDEAYA advances darovasertib toward a potential accelerated approval filing, the regulatory compliance risk intensifies. The move from clinical development to commercial readiness requires a significant legal and compliance overhaul, covering everything from manufacturing quality systems to promotional materials review.

The darovasertib program is currently in a registrational Phase 2/3 trial for first-line (1L) HLA-A2-negative metastatic uveal melanoma (MUM), which has enrolled over 300 patients as of May 2025, targeting a median Progression-Free Survival (PFS) readout by year-end 2025. The company also received U.S. FDA Breakthrough Therapy Designation for darovasertib in neoadjuvant uveal melanoma (UM), which brings faster review but also heightened regulatory interaction and scrutiny.

This increased activity is already visible in the financials. The company's General and Administrative (G&A) expenses for the third quarter of 2025 rose to $16.4 million, up from $14.6 million in the second quarter of 2025, driven primarily by 'higher legal expenses to support company growth and commercial expenses to support the darovasertib commercial preparation activities'. That's a 12.3% quarter-over-quarter increase in G&A, showing the legal cost of approaching commercialization.

IDEAYA Biosciences, Inc. (IDYA) - PESTLE Analysis: Environmental factors

The company's third-party net impact ratio is 66.9%, indicating an overall positive sustainability impact due to its core mission.

IDEAYA Biosciences, as a precision oncology company, naturally scores high on the positive side of the sustainability ledger because its core mission-developing transformative cancer therapies-creates significant societal value. This is quantified by a third-party net impact ratio of 66.9%, a strong figure that reflects the positive impact in categories like 'Physical diseases' and 'Health' outweighing the negative operational impact.

The company's focus on oncology targets like GNAQ/GNA11 mutations and MTAP deletion (prevalent in approximately 15% of all solid tumors) means the potential for patient benefit is substantial.

Focus on drug discovery means a smaller direct carbon footprint compared to large-scale manufacturing.

As a clinical-stage biotech, IDEAYA's direct environmental footprint (Scope 1 and 2 emissions) is inherently smaller than that of a fully commercialized pharmaceutical manufacturer. Its operations center on research and development (R&D) rather than large-scale production. However, R&D expenses still totaled $83.0 million for the third quarter of 2025, reflecting significant laboratory activity, which is the primary source of its direct footprint.

The industry trend in 2025 is toward mitigating this lab-based impact through energy efficiency. For instance, many biopharma firms are upgrading equipment like ultra-low temperature freezers, which can be massive energy consumers.

Biotech operations face general industry pressure to manage laboratory and clinical trial waste effectively.

The primary environmental challenge for IDEAYA is waste management, specifically the disposal of biological and chemical waste from its preclinical and clinical activities. Third-party analysts specifically cite 'Waste' as one of the categories where the company causes negative impacts.

This pressure is compounded by the industry-wide adoption of single-use technologies (SUTs) in labs, which streamline processes but escalate non-recycled waste volume. The financial and regulatory pressure is clear: major pharma companies are now spending $5.2 billion annually on environmental programs, a 300% increase from 2020, signaling that waste compliance is a major cost center.

• Limit hazardous material use in labs.
• Implement waste recycling systems for non-hazardous materials.
• Manage clinical trial-related biohazardous waste disposal.

Supply chain logistics for global clinical trials increase the indirect environmental and carbon footprint.

The most significant environmental risk for IDEAYA is its indirect footprint, or Scope 3 emissions, driven by global clinical trial logistics. The scale of their 2025 pipeline demonstrates this challenge: the registrational Phase 2/3 trial for darovasertib and crizotinib enrolled over 350 patients as of August 2025, with a target of approximately 400 patients by year-end.

Managing the global distribution of investigational drugs, patient samples, and clinical supplies across multiple countries-including the multi-site Phase 1 trial for IDE849 in China-creates substantial emissions from air and road freight.

Here's the quick math on the operational scale driving this indirect impact:

Metric (as of 2025)	Value/Amount	Environmental Implication
R&D Expenses (Q3 2025)	$83.0 million	Direct lab energy and waste generation.
Darovasertib Trial Enrollment (Target YE 2025)	Approx. 400 patients	Scale of global drug and sample logistics.
Cash Runway Extension	Into 2030	Long-term commitment to a growing operational footprint.

This global footprint means the company must defintely consider its third-party logistics (3PL) providers' sustainability performance, as that is where the bulk of its carbon exposure lies.