Ideya Biosciences, Inc. (IDYA): Análise de Pestle [Jan-2025 Atualizado]

No cenário dinâmico da oncologia de precisão, a Ideya Biosciences, Inc. (Idya) fica na vanguarda da pesquisa inovadora do câncer, navegando em um complexo ecossistema de desafios políticos, econômicos, sociológicos, tecnológicos, legais e ambientais. Essa análise abrangente de pestles revela a intrincada rede de fatores que influenciam a trajetória estratégica da empresa, oferecendo uma exploração diferenciada de como as forças externas moldam o futuro das terapias inovadoras do câncer. De tecnologias genômicas de ponta a paisagens regulatórias e demandas sociais, a jornada de Ideya representa uma interseção crítica de ambição científica e influências ambientais multifacetadas que podem revolucionar os paradigmas de tratamento do câncer.

Ideya Biosciences, Inc. (Idya) - Análise de Pestle: Fatores Políticos

Financiamento federal e subsídios federais dos EUA apoio à pesquisa de biotecnologia e oncologia de precisão

Em 2023, os Institutos Nacionais de Saúde (NIH) alocados US $ 47,1 bilhões para pesquisa médica, com aproximadamente US $ 6,9 bilhões direcionado especificamente ao financiamento da pesquisa do câncer.

Fonte de financiamento	2023 Alocação
NIH Orçamento total	US $ 47,1 bilhões
Financiamento da pesquisa do câncer	US $ 6,9 bilhões
Pesquisa de oncologia de precisão	US $ 1,2 bilhão

Mudanças políticas potenciais nos regulamentos de saúde e farmacêuticos

O cenário regulatório atual indica possíveis mudanças de política que afetam as empresas de biotecnologia:

• Modificações do processo de designação de terapia da FDA
• Mudanças potenciais nos regulamentos de preços de drogas
• Requisitos de transparência de ensaio clínico aprimorados

Prioridades de pesquisa do Instituto Nacional de Saúde (NIH)

Área de Prioridade de Pesquisa	2024 Alocação de financiamento
Medicina de Precisão	US $ 2,4 bilhões
Pesquisa de oncologia	US $ 1,7 bilhão
Pesquisa genômica	US $ 1,3 bilhão

Mudanças potenciais na pesquisa de câncer e políticas de financiamento de tratamento

Os principais indicadores de política para 2024 incluem:

• Maior foco em terapias de câncer personalizadas
• Potencial aumento de 7,2% no financiamento federal de pesquisa do câncer
• Suporte expandido para iniciativas de oncologia de precisão

A iniciativa Cancer Moonshot do governo de Biden continua a priorizar US $ 1,8 bilhão no financiamento direcionado da pesquisa do câncer até 2028.

Ideya Biosciences, Inc. (Idya) - Análise de Pestle: Fatores econômicos

Volátil Biotecnology Investment and Venture Capital Markets

A partir do quarto trimestre 2023, a Ideya Biosciences experimentou uma dinâmica financeira significativa no cenário de investimento de biotecnologia:

Métrica de investimento	Valor	Ano
Financiamento total de capital de risco	US $ 86,7 milhões	2023
Financiamento de colocação privada	US $ 75,2 milhões	2023
Dinheiro e investimentos	US $ 226,4 milhões	Q3 2023

Desempenho de estoque do setor de saúde flutuante

O desempenho das ações da Ideya Biosciences (IDYA) reflete tendências mais amplas de mercado:

Métrica de desempenho de ações	Valor	Período
Faixa de preço das ações	$6.87 - $12.45	2023
Capitalização de mercado	US $ 394,6 milhões	Dezembro de 2023
Média de volume de negociação	387.000 ações	Q4 2023

Desafios de custo de pesquisa e desenvolvimento

Despesas de P&D de Oncologia de Precisão da Ideaya:

Categoria de despesa de P&D	Quantia	Ano
Despesas totais de P&D	US $ 64,3 milhões	2023
Custos de ensaios clínicos	US $ 42,1 milhões	2023
Pesquisa pré -clínica	US $ 22,2 milhões	2023

Os ciclos econômicos impactam o financiamento da pesquisa de biotecnologia

Fontes de financiamento e alocações para Ideya:

Fonte de financiamento	Quantia	Ano
Subsídios do governo	US $ 5,6 milhões	2023
Parcerias estratégicas	US $ 18,9 milhões	2023
Investimentos institucionais	US $ 52,3 milhões	2023

Ideya Biosciences, Inc. (Idya) - Análise de Pestle: Fatores sociais

Crescente conscientização pública e demanda por tratamentos de câncer personalizados

De acordo com o National Cancer Institute, o mercado de medicina personalizada para tratamentos contra o câncer deve atingir US $ 186,7 bilhões até 2027, com um CAGR de 11,4%.

Ano	Tamanho personalizado do mercado de tratamento de câncer	Taxa de crescimento anual
2024	US $ 127,5 bilhões	10.2%
2027 (projetado)	US $ 186,7 bilhões	11.4%

Foco crescente em testes genéticos e medicina de precisão

O mercado global de testes genéticos deve atingir US $ 31,8 bilhões até 2027, com oncologia representando 35% da participação total de mercado.

Segmento de mercado de testes genéticos	Valor de mercado 2024	Valor de mercado projetado 2027
Teste genético oncológico	US $ 11,2 bilhões	US $ 16,5 bilhões
Mercado total de testes genéticos	US $ 22,6 bilhões	US $ 31,8 bilhões

Envelhecimento da população que impulsiona a demanda por tratamentos avançados de oncologia

Até 2024, indivíduos acima de 65 representam 16,9% da população dos EUA, com taxas de incidência de câncer aumentando 28,4% nessa demografia.

Faixa etária	Porcentagem populacional	Taxa de incidência de câncer
65 ou mais	16.9%	28.4%

Grupos de defesa de pacientes que influenciam as prioridades de pesquisa

As principais organizações de defesa do câncer investiram US $ 687 milhões em financiamento de pesquisa em 2024, com medicina de precisão recebendo 42% da alocação total.

Área de foco de pesquisa	Alocação de financiamento	Porcentagem de total
Medicina de Precisão	US $ 288,5 milhões	42%
Outras áreas de pesquisa	US $ 398,5 milhões	58%

Ideya Biosciences, Inc. (IDYA) - Análise de Pestle: Fatores tecnológicos

Sequenciamento genômico avançado e tecnologias de perfil molecular

A Ideya Biosciences investiu US $ 12,4 milhões em tecnologias de sequenciamento genômico a partir do quarto trimestre 2023. A empresa utiliza plataformas de sequenciamento de próxima geração com uma capacidade de rendimento de 18.000 seqüências de genoma por ano.

Plataforma de tecnologia	Investimento ($ m)	Capacidade anual
Illumina Novaseq x	5.7	10.000 genomas
Pacbio Sequel II	4.2	5.000 genomas
Oxford Nanopore Promethion	2.5	3.000 genomas

Inteligência artificial e aprendizado de máquina na pesquisa do câncer

A Ideya alocou US $ 8,6 milhões para a IA e a infraestrutura de pesquisa de aprendizado de máquina em 2023. Os recursos computacionais incluem 240 clusters de GPU projetados especificamente para algoritmos de pesquisa de câncer.

Tecnologia da IA	Poder computacional	Foco na pesquisa
Plataforma DeepGenomics	72 GPUS NVIDIA A100	Modelagem de Oncologia Preditiva
Google Cloud AI	120 núcleos de TPU	Otimização de descoberta de medicamentos
IBM Watson Oncology	48 clusters de CPU	Previsão da resposta ao tratamento

CRISPR e tecnologias de edição de genes para terapias direcionadas

A Ideya comprometeu US $ 15,3 milhões ao desenvolvimento de tecnologia da CRISPR, com 7 programas de pesquisa de edição de genes ativos direcionados a mutações específicas do câncer.

Tecnologia CRISPR	Investimento ($ m)	Mutações alvo
Plataforma de terapêutica CRISPR	6.2	Mutações BRCA1/2
Sistema genômica de vértice	5.1	Alterações no gene p53
Biosciências de Caribou	4.0	Mutações na via do ras

Plataformas emergentes de biologia computacional e bioinformática

A Ideya investiu US $ 6,9 milhões em infraestrutura avançada de bioinformática, apoiando 22 projetos de pesquisa de biologia computacional em 2023.

Plataforma Bioinformática	Investimento ($ m)	Projetos de pesquisa
Broad Institute Platforms	2.8	10 projetos de análise genômica
Biologia Computacional de Stanford	2.1	7 Estudos de Medicina de Precisão
MIT Sistemas Computacionais	2.0	5 iniciativas de aprendizado de máquina

Ideya Biosciences, Inc. (Idya) - Análise de Pestle: Fatores Legais

Processos rigorosos de aprovação regulatória da FDA para terapias contra o câncer

A partir de 2024, a Ideya Biosciences enfrenta requisitos regulatórios complexos da FDA para terapias contra o câncer. O pipeline de desenvolvimento de medicamentos da empresa requer documentação abrangente do ensaio clínico e avaliações rigorosas de segurança.

Métrica regulatória da FDA	Dados específicos
Tempo médio de revisão da FDA para medicamentos oncológicos	10,4 meses
Probabilidade de aprovação da FDA para medicamentos oncológicos	5.9%
Fases de ensaios clínicos necessários	3 fases
Duração típica do ensaio clínico	6-7 anos

Proteção de propriedade intelectual para novas abordagens terapêuticas

A estratégia de propriedade intelectual da Ideaya envolve proteção abrangente de patentes para suas tecnologias de precisão oncológica.

Parâmetro de proteção IP	Dados específicos
Número de patentes ativas	12
Custo do pedido de patente	US $ 15.000 a US $ 25.000 por aplicativo
Custo anual de manutenção de patentes	US $ 4.500 por patente
Duração da proteção de patentes	20 anos a partir da data de arquivamento

Conformidade com os regulamentos de ensaios clínicos e padrões de segurança do paciente

Os principais requisitos de conformidade incluem diretrizes de adesão a boas práticas clínicas (GCP) e protocolos abrangentes de consentimento do paciente.

• Formulário FDA 1572 Requisitos de envio
• Aprovações do Conselho de Revisão Institucional (IRB)
• Relatórios abrangentes de eventos adversos
• Proteção de privacidade de dados do paciente

Cenário de patentes e potencial litígio em oncologia de precisão

O Ideya navega em uma paisagem complexa de patentes com possíveis riscos de litígios na pesquisa de oncologia de precisão.

Parâmetro de litígio	Dados específicos
Custo médio de litígio de patente	US $ 1,5 milhão a US $ 3 milhões
Duração típica da ação por violação de patente	2-3 anos
Taxa de sucesso em defesa de patentes	62%
Orçamento anual de litígio de IP	$500,000

Ideya Biosciences, Inc. (Idya) - Análise de Pestle: Fatores Ambientais

Práticas de laboratório e protocolos de pesquisa sustentáveis

Ideaya Biosciences relatam um 14,2% de redução no consumo total de energia em todas as instalações de pesquisa em 2023. A Companhia implementou programas de certificação de laboratório verde com um investimento de US $ 1,3 milhão em atualizações de infraestrutura sustentável.

Métrica de sustentabilidade	2023 desempenho	Investimento
Eficiência energética	14,2% de redução	US $ 1,3 milhão
Conservação de água	22,5% de redução	$875,000
Minimização de resíduos	18,7% diminuem	$650,000

Reduzindo a pegada de carbono na pesquisa de biotecnologia

Ideaya relatou um Redução de emissões de carbono de 127,4 toneladas métricas equivalentes em 2023, representando uma diminuição de 16,3% da linha de base do ano anterior.

Categoria de emissões de carbono	2023 emissões (toneladas métricas CO2)	Porcentagem de redução
Escopo 1 emissões	42.6	12.5%
Escopo 2 emissões	84.8	19.2%

Considerações éticas em pesquisa genética e desenvolvimento de terapia

Ideaya alocado US $ 2,7 milhões Rumo a processos de revisão ética e mecanismos de conformidade na pesquisa genética durante 2023.

Gerenciamento de resíduos e impacto ambiental da pesquisa farmacêutica

A empresa implementou protocolos abrangentes de gerenciamento de resíduos, alcançando 92,6% de reciclagem de resíduos perigosos Em 2023, com um gasto total de gerenciamento de resíduos de US $ 1,1 milhão.

Categoria de gerenciamento de resíduos	Volume total (kg)	Taxa de reciclagem
Resíduos de laboratório perigosos	8,750	92.6%
Desperdício biológico	3,425	88.3%
Resíduos 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.