FibroGen, Inc. (FGEN): Análisis de la Matriz ANSOFF [Actualizado en Ene-2025]

En el panorama dinámico de la biotecnología, Fibrogen, Inc. se encuentra en una encrucijada fundamental de transformación estratégica, trazando meticulosamente una trayectoria de crecimiento multifacética que trasciende los límites farmacéuticos tradicionales. Con una ambiciosa matriz de Ansoff preparada para revolucionar los tratamientos de nefrología y hematología, la compañía se está posicionando estratégicamente para expandir el alcance del mercado, innovar soluciones terapéuticas y explorar oportunidades sin precedentes en los paisajes internacionales. Desde estrategias de ventas específicas hasta iniciativas innovadoras de investigación, el enfoque integral de Fibrogen promete redefinir los contornos de intervenciones médicas personalizadas, invitando a las partes interesadas y a los observadores de la industria a profundizar en su visionaria hoja de ruta.

Fibrogen, Inc. (FGEN) - Ansoff Matrix: Penetración del mercado

Expandir la fuerza de ventas directa dirigida a especialistas en nefrología y hematología clave

A partir del cuarto trimestre de 2022, Fibrogen empleó 290 representantes de ventas centrados en los mercados de atención especializada. La compañía asignó $ 42.3 millones a los gastos de ventas y marketing en 2022.

Métrica de la fuerza de ventas	Datos 2022
Representantes de ventas totales	290
Ventas & Gastos de marketing	$ 42.3 millones
Médicos especializados en el objetivo	3.750 especialistas en nefrología/hematología

Aumentar los esfuerzos de marketing para Roxadustat en los mercados de enfermedades renales crónicas

Roxadustat generó $ 224.7 millones en ingresos netos de productos para 2022. Se proyecta que el mercado de enfermedades renales crónicas alcanzará los $ 22.5 mil millones para 2026.

• 2022 ROXADUSTAT INGRESOS: $ 224.7 millones
• Tamaño del mercado objetivo: $ 22.5 mil millones para 2026
• Población de pacientes objetivo: 37 millones de pacientes con enfermedad renal crónica en los Estados Unidos

Optimizar las estrategias de precios para mejorar el posicionamiento competitivo

El costo promedio de adquisición al por mayor de Roxadustat oscila entre $ 1,200 y $ 1,800 por ciclo de tratamiento mensual.

Componente de precios	Valor
Costo de tratamiento mensual	$1,200 - $1,800
Diferencial de precios competitivos	7-12% por debajo de las alternativas de mercado

Mejorar los programas de apoyo al paciente para mejorar la adherencia a los medicamentos

Fibrogen invirtió $ 8.6 millones en programas de apoyo y asistencia del paciente en 2022.

• Presupuesto de apoyo al paciente: $ 8.6 millones
• Objetivo de adherencia de medicamentos: aumento del 62% al 75%
• Inscripción del programa de asistencia del paciente: 4.200 pacientes

Fortalecer las relaciones con los proveedores de atención médica y los centros de tratamiento existentes

Fibrogen mantuvo relaciones con 1.275 centros de tratamiento de salud en 2022.

Métrica de relación de proveedor	Datos 2022
Centros de tratamiento comprometidos	1,275
Acuerdos de asociación clínica	87 asociaciones activas
Programas de educación de proveedores	42 realizado en 2022

Fibrogen, Inc. (FGEN) - Ansoff Matrix: Desarrollo del mercado

Oportunidades de expansión internacional en los mercados europeos y asiáticos

Fibrogen reportó ingresos internacionales de 2022 de $ 78.3 millones, con un enfoque específico en los mercados asiáticos. Roxadustat recibió la aprobación en China, generando $ 94.8 millones en ventas netas para 2022.

Mercado	Tamaño potencial del mercado	Estado regulatorio
Porcelana	$ 385 millones en el mercado potencial	Aprobado para el tratamiento de anemia
Japón	Mercado potencial de $ 210 millones	Aprobación regulatoria parcial
unión Europea	Mercado potencial de $ 275 millones	Revisión regulatoria pendiente

Aprobaciones regulatorias en países adicionales

A partir de 2022, el fibrogen tiene presentaciones regulatorias activas en 6 países para Roxadustat.

• China: aprobación total recibida
• Japón: aprobación parcial
• Unión Europea: bajo revisión
• Estados Unidos: discusiones en curso con la FDA

Objetivo de nuevos segmentos terapéuticos

El enfoque terapéutico actual de Fibrogen incluye enfermedad renal y tratamientos de anemia. Roxadustat generó $ 198.2 millones en ventas netas totales en 2022.

Área terapéutica	Potencial de mercado	Etapa de desarrollo actual
Nefropatía	Mercado global de $ 12.5 mil millones	Ensayos clínicos avanzados
Tratamiento de anemia	Mercado global de $ 8.7 mil millones	Producto comercializado

Asociaciones estratégicas

Fibrogen ha establecido asociaciones con Astellas Pharma y CSPC Pharmaceutical Group, generando ingresos colaborativos de $ 45.6 millones en 2022.

Investigación de mercado para mercados geográficos sin explotar

Fibrogen identificó la expansión potencial en los mercados emergentes con una población de pacientes estimada de 3,2 millones para tratamientos renales y de anemia.

• India: 1.1 millones de pacientes potenciales
• Brasil: 0,7 millones de pacientes potenciales
• Sudeste de Asia: 1,4 millones de pacientes potenciales

Fibrogen, Inc. (FGEN) - Ansoff Matrix: Desarrollo de productos

Invierta en investigación y desarrollo de nuevos compuestos terapéuticos

En 2022, Fibrogen invirtió $ 217.3 millones en gastos de investigación y desarrollo. La compañía se centró en desarrollar terapias innovadoras en múltiples áreas de enfermedades.

Año	Inversión de I + D	Áreas de enfoque clave
2022	$ 217.3 millones	Trastornos sanguíneos raros, enfermedades renales
2021	$ 252.1 millones	Anemia, enfermedades fibróticas

Expandir la tubería para posibles tratamientos en trastornos sanguíneos raros

Fibrogen actualmente tiene 4 candidatos terapéuticos activos en etapa clínica dirigida a trastornos sanguíneos raros.

• Roxadustat: aprobado para el tratamiento de anemia en enfermedad renal crónica
• Pamrevlumab: tratamiento potencial para la distrofia muscular de Duchenne
• FG-3087: Desarrollo de etapas tempranas para la fibrosis pulmonar

Desarrollar diagnósticos complementarios para apoyar el enfoque de medicina personalizada

La compañía ha invertido aproximadamente $ 35.4 millones en el desarrollo de tecnologías de diagnóstico para apoyar estrategias de medicina personalizada.

Tecnología de diagnóstico	Enfermedad objetivo	Etapa de desarrollo
Plataforma de identificación de biomarcador	Enfermedades renales	Investigación avanzada
Herramienta de detección genética	Trastornos de sangre raros	Preclínico

Mejorar las formulaciones de medicamentos existentes para mejorar los resultados de los pacientes

Fibrogen tiene 3 proyectos en curso de reformulación de drogas con potencial para mejorar las propiedades farmacocinéticas.

• Formulación de liberación prolongada de Roxadustat
• Régimen de dosificación mejorado para pamrevlumab
• Estabilidad mejorada para FG-3087

Explore posibles nuevas indicaciones para la cartera de medicamentos actual

La compañía está investigando 5 nuevas indicaciones terapéuticas potenciales en su cartera de drogas existente.

Droga	Indicación actual	Posibles nuevas indicaciones
Roxadustat	Anemia en ERC	Anemia relacionada con el cáncer, insuficiencia cardíaca
Pamrevlumab	Distrofia muscular de Duchenne	Fibrosis pulmonar idiopática

Fibrogen, Inc. (FGEN) - Ansoff Matrix: Diversificación

Investigar posibles adquisiciones estratégicas en el sector de la biotecnología

La capitalización de mercado de Fibrogen de $ 360.22 millones a partir del tercer trimestre de 2023 proporciona una capacidad de adquisición estratégica potencial. El efectivo y los equivalentes de efectivo de la compañía fueron de $ 316.7 millones al 30 de junio de 2023.

Posibles criterios de adquisición	Parámetros financieros
Tamaño objetivo de la empresa	Capitalización de mercado de $ 50-200 millones
Asignación de presupuesto de investigación	$ 15-25 millones para posibles adquisiciones

Explore oportunidades en áreas terapéuticas adyacentes como la oncología

El mercado de oncología proyectado para llegar a $ 269.4 mil millones para 2026. Los gastos actuales de investigación y desarrollo de Fibrogen fueron de $ 242.6 millones en 2022.

• Objetivo de inversión de oncología potencial: $ 50-75 millones
• Costo de entrada al mercado estimado: $ 25-40 millones

Desarrollar tecnologías de salud digital

Se espera que el mercado de salud digital alcance los $ 639.4 mil millones para 2026.

Categoría de tecnología	Inversión estimada
Plataformas de diagnóstico impulsadas por IA	$ 10-20 millones
Monitoreo de pacientes remotos	$ 15-25 millones

Crear plataformas de diagnóstico para trastornos renales y sanguíneos

Mercado mundial de diagnóstico de enfermedad renal valorado en $ 8.3 mil millones en 2022.

• Costo de desarrollo potencial de la plataforma: $ 30-45 millones
• Penetración estimada del mercado: 5-7% en 3 años

Establecer un brazo de capital de riesgo

Asignación inicial del Fondo de Capital de Venture: $ 50-75 millones.

Enfoque de inversión	Porcentaje de asignación
Startups de biotecnología de la etapa temprana	40-50%
Tecnologías de salud digital	30-35%
Tecnología de diagnóstico	15-20%

FibroGen, Inc. (FGEN) - Ansoff Matrix: Market Penetration

Maximize Roxadustat's value in existing licensed territories.

Roxadustat is approved in China, Europe, Japan, and numerous other countries for the treatment of anemia of CKD in adult patients on dialysis (DD) and not on dialysis (NDD).

FibroGen completed the sale of FibroGen China to AstraZeneca in the third quarter of 2025 for a total consideration of approximately $220 million, consisting of $85 million in enterprise value and approximately $135 million in net cash held in China.

FibroGen maintains the sole rights to roxadustat in the United States, Canada, Mexico, and in all markets not held by AstraZeneca or licensed to Astellas.

Astellas and FibroGen are collaborating on the commercialization of roxadustat in territories including Japan, Europe, Turkey, Russia, and the Commonwealth of Independent States, the Middle East, and South Africa.

Increase U.S. physician awareness of Roxadustat's mechanism (HIF-PHI).

Roxadustat is described as the first in a new class of medicines comprising HIF-PH inhibitors that promote erythropoiesis.

Prepare U.S. commercial infrastructure for Roxadustat's LR-MDS launch.

FibroGen reported cash, cash equivalents, accounts receivable, and investments of $121.1 million on September 30, 2025.

The Company expects its cash, cash equivalents, accounts receivable, and investments to be sufficient to fund operating plans into 2028.

The company's Q3 2025 net loss from continuing operations was $13.1 million.

The company's total revenue from continuing operations for the third quarter of 2025 was $1.1 million.

FibroGen's lack of commercial infrastructure could delay market entry.

Negotiate favorable U.S. payer coverage for Roxadustat post-approval.

The company is advancing roxadustat for the treatment of anemia in patients with lower-risk myelodysplastic syndromes (LR-MDS) and high red blood cell (RBC) transfusion burden.

FibroGen intends to file the pivotal Phase 3 clinical trial protocol for roxadustat in LR-MDS in the fourth quarter of 2025.

The planned Phase 3 trial will enroll approximately 200 patients.

Defintely focus marketing spend on high-volume anemia centers.

In a post-hoc subgroup analysis from the MATTERHORN Phase 3 trial, 36% of patients with high transfusion burden achieved transfusion independence for at least 56 days on roxadustat compared to 7% on placebo.

Approximately 80% of patients with MDS have anemia at the time of diagnosis.

Around 60% of patients with MDS will experience severe anemia (hemoglobin <8 g/dL) at some point during the course of their disease.

The following table summarizes key financial and development metrics relevant to the U.S. market strategy as of late 2025:

Metric	Value (2025 Data)	Context
Consolidated Cash, Investments, AR (Sep 30, 2025)	$121.1 million	Cash runway expected into 2028
Q3 2025 Revenue (Continuing Operations)	$1.1 million	Compared to $0.1 million in Q3 2024
Q3 2025 Net Loss (Continuing Operations)	$13.1 million	Compared to a loss of $48.3 million one year ago
FibroGen China Sale Consideration	Approx. $220 million	Completed in Q3 2025
Planned LR-MDS Phase 3 Enrollment	Approx. 200 patients	Protocol submission anticipated Q4 2025
LR-MDS Trial Efficacy (Roxadustat TI >= 56 days)	36%	Compared to 7% on placebo in subgroup analysis

The following are key operational milestones related to the U.S. LR-MDS indication:

• Reached agreement with the U.S. Food and Drug Administration (FDA) on important design elements for a pivotal Phase 3 trial.
• Final Phase 3 protocol submission anticipated in the fourth quarter of 2025.
• The patient population for the Phase 3 trial will include those refractory to, intolerant to, or ineligible for prior erythropoiesis-stimulating agents therapy.
• Annual incidence rates of MDS are estimated to be 4.9/100,000 adults in the U.S.

FibroGen, Inc. (FGEN) - Ansoff Matrix: Market Development

You're looking at how FibroGen, Inc. (FGEN) can take its existing product, Roxadustat, into new markets or new patient segments. This is the essence of Market Development in the Ansoff Matrix. Given the recent financial restructuring, understanding the capacity for this expansion is key.

Financially, as of September 30, 2025, FibroGen, Inc. reported cash, cash equivalents, investments, and accounts receivable totaling $121.1 million. This balance, coupled with the recent completion of the sale of FibroGen China for approximately $220 million, provides a cash runway extending into 2028. The company estimates the pivotal Phase 3 trial for LR-MDS could cost roughly $50-$60 million.

Secure U.S. FDA Approval for Roxadustat in LR-MDS Anemia

The immediate focus for U.S. market development is securing approval for Roxadustat in anemia associated with lower-risk myelodysplastic syndromes (LR-MDS). This is a specific new patient segment within the U.S. market where the drug is not yet approved. The regulatory pathway is anchored by a post-hoc subgroup analysis from the MATTERHORN Phase 3 trial, which showed compelling efficacy in patients with high red blood cell (RBC) transfusion burden.

The data supporting this push showed that among patients requiring $\ge$ 4 units of RBC transfusion over 8 weeks at baseline, 36% (8/22) achieved transfusion independence for $\ge$ 56 days on roxadustat compared to 7% (1/15) on placebo within 28 weeks, with a nominal p-value of 0.041. The U.S. market for this indication has an estimated annual incidence of MDS of 4.9 per 100,000 adults, with 77% classified as LR-MDS. Approximately 50% of these patients require regular transfusions.

Initiate the Pivotal Phase 3 Trial for Roxadustat in LR-MDS in Q4 2025

FibroGen, Inc. has reached agreement with the U.S. Food and Drug Administration (FDA) on important design elements for this pivotal trial. The company intends to file the full Phase 3 protocol in the fourth quarter of 2025. This trial will be a randomized, double-blind, placebo-controlled study enrolling approximately 200 patients. The primary endpoint under consideration is either 8-week or 16-week RBC transfusion independence.

Key parameters for the planned Phase 3 trial include:

• Enrollment target: Approximately 200 patients.
• Patient criteria: Refractory to, intolerant to, or ineligible for prior erythropoiesis-stimulating agents (ESA) therapy.
• Transfusion burden: Requiring $\ge$ 4 pRBC units in two consecutive 8-week periods prior to randomization.
• Protocol submission target: Q4 2025.

Explore Partnership Options for Roxadustat in Canada and Mexico

FibroGen, Inc. holds the sole rights to roxadustat in the United States, Canada, and Mexico. Following the positive FDA feedback for the LR-MDS indication, the company stated it is evaluating internal development and potential partnership opportunities for this late-stage program. Given the estimated cost of the Phase 3 trial, running it without a partner could shorten the cash runway into H2 2027 unless additional capital is raised.

The current commercial rights structure for Roxadustat is:

Territory	Rights Holder	Status/Collaboration
U.S., Canada, Mexico	FibroGen, Inc.	Evaluating internal development/partnership for LR-MDS
China, South Korea	AstraZeneca (post-sale)	Approved for CKD anemia; sNDA accepted for CIA
Japan, Europe, Turkey, Russia, CIS, Middle East, South Africa	Astellas	Collaboration for commercialization

Investigate Roxadustat for Other Anemia Indications like Chemotherapy-Induced Anemia (CIA)

Roxadustat is in clinical development for CIA, which is a major area of unmet need. The drug previously met its primary efficacy endpoint in the Phase 2 WHITNEY trial, which enrolled 92 patients with non-myeloid malignancy and hemoglobin $\le$ 10 g/dL. Furthermore, a pivotal Phase 3 study in China for CIA demonstrated non-inferiority to recombinant erythropoietin alfa (SEPO®) in 159 patients. Roxadustat is already approved in China for anemia of CKD, and a Supplemental New Drug Application (sNDA) for CIA in China has been accepted by the China Health Authority.

Target New Patient Segments within the Broader Anemia Market

The primary Market Development focus is shifting from the already-approved Chronic Kidney Disease (CKD) anemia market to the LR-MDS patient population with high transfusion burden. This represents a distinct, high-need segment in the U.S. market. The total addressable population for MDS in the U.S. is estimated to be approximately 75K patients.

FibroGen, Inc.'s Q3 2025 financial performance shows a net loss from continuing operations of $13.1 million and total revenue from continuing operations of $1.1 million. The company's R&D expenses for Q3 2025 were $1.2 million, a significant decrease from $20 million in Q3 2024. This reduced burn rate supports the internal funding evaluation for the LR-MDS Phase 3 trial, estimated at $50-$60 million.

FibroGen, Inc. (FGEN) - Ansoff Matrix: Product Development

You're looking at the near-term execution plan for FibroGen, Inc.'s key pipeline assets, which is heavily concentrated on advancing the antibody-drug conjugate (ADC), FG-3246, in the U.S. market for metastatic castration-resistant prostate cancer (mCRPC).

Advancing FG-3246 through Phase 2 for mCRPC

FibroGen, Inc. has moved forward with the development of FG-3246, a potential first-in-class CD46-targeting ADC, by initiating the Phase 2 monotherapy dose-optimization study in the U.S. for mCRPC patients. This is a critical step for this new product in an existing market segment.

The Phase 2 monotherapy trial for FG-3246 officially started in the third quarter of 2025. This trial is designed to enroll 75 patients who are in the post-androgen receptor signaling inhibitor (ARSI) and pre-chemotherapy setting. The study design randomizes patients across three dose levels to find the optimal dose for a future pivotal trial.

Key parameters for the FG-3246 Phase 2 trial include:

• Enrollment target: 75 patients.
• Dose arms: 1.8 mg/kg, 2.4 mg/kg, and 2.7 mg/kg adjusted body weight (AJBW).
• Primary endpoint focus: Determining the optimal dose based on efficacy, safety, and PK parameters.
• Interim analysis timing: Anticipated in the second half of 2026 (2H 2026).
• Final trial completion expected: March 2028.

Developing FG-3180 Alongside FG-3246

The development of FG-3180, the companion Positron Emission Tomography (PET) diagnostic agent, is intrinsically linked to the FG-3246 program. FG-3180 shares the same anti-CD46 antibody, YS5, as FG-3246. This co-development strategy aims to establish FG-3180 as a predictive patient selection biomarker.

The assessment of FG-3180 is integrated directly into the ongoing FG-3246 trials. Specifically, all patients deemed eligible for the Phase 2 trial will participate in the FG-3180 sub-study before randomization. This allows FibroGen, Inc. to evaluate the diagnostic performance and the potential correlation between CD46 expression identified by FG-3180 and the patient response to FG-3246.

Here's a look at the data milestones tied to both assets:

Study/Data Point	Asset(s) Involved	Expected Timing
Top-line Results (Investigator-Sponsored Combination Study)	FG-3246 + enzalutamide, including FG-3180 data	Q4 2025
Interim Analysis (Phase 2 Monotherapy Trial)	FG-3246 and FG-3180 evaluation	2H 2026

Generating Positive Top-Line Data from Combination Study

FibroGen, Inc. is scheduled to report topline data from the investigator-sponsored Phase 1b/2 study evaluating FG-3246 in combination with enzalutamide in mCRPC patients during the fourth quarter of 2025 (Q4 2025). This data readout is a near-term catalyst for the asset.

To be more precise, these results are expected to be presented at a medical conference in the first quarter of 2026 (1Q 2026). The data from this combination study will incorporate information gathered on the companion diagnostic, FG-3180.

Investigating New Formulations or Delivery Methods

The immediate focus for product development is on advancing the current ADC construct, FG-3246, through the dose-optimization Phase 2 trial. The company has not publicly detailed specific timelines or financial allocations for investigating new formulations or delivery methods for FG-3246 as of the third quarter of 2025. The current financial planning, supported by the recent sale of FibroGen China for approximately $220 million, is geared toward funding the U.S. development initiatives, including the FG-3246 program, with a cash runway extending into 2028. The Q3 2025 Research and Development expenses were reported at $1.2 million.

The company's current cash position as of September 30, 2025, stood at $121.1 million in cash, cash equivalents, investments, and accounts receivable.

Finance: draft updated 13-week cash view incorporating Q3 2025 actuals by next Tuesday.

FibroGen, Inc. (FGEN) - Ansoff Matrix: Diversification

You're looking at FibroGen, Inc. (FGEN) post-China sale, with a clear mandate to deploy capital into the U.S. pipeline. The financial foundation is set for near-term action, but the path to offsetting the recent quarterly deficit requires strategic diversification beyond the core anemia program.

The balance sheet as of September 30, 2025, shows $121.1 million in cash, cash equivalents, accounts receivable, and investments. This liquidity is significant, especially since the transformative sale of FibroGen China for approximately $220 million (including $135 million in net cash held in China) extended the cash runway into 2028. This positions FibroGen, Inc. to pursue growth vectors outside of its established anemia franchise.

To address the immediate financial performance, consider the Q3 2025 results. The net loss from continuing operations was $13.1 million. Acquiring a small, revenue-generating specialty pharma company could provide an immediate, albeit modest, offset to this recurring loss structure, offering a different revenue stream to stabilize the burn rate while core assets mature.

The oncology pipeline offers the clearest path for product development diversification. FG-3246, the anti-CD46 antibody-drug conjugate (ADC) in-licensed from Fortis Therapeutics, is already advancing. The Phase 2 monotherapy dose optimization trial in metastatic castration-resistant prostate cancer (mCRPC) was initiated in the third quarter of 2025. Given that FG-3246 binds to CD46, which is present at high levels in prostate cancer and other tumor types, expanding this development beyond mCRPC into other CD46-expressing solid tumors is a logical next step to maximize the asset's potential addressable market, which is estimated to be well over $5 billion annually for mCRPC alone.

The company's existing immuno-oncology assets also present partnership opportunities. FG-3165, the galectin-9 (Gal9) targeted antibody, has already cleared its Investigational New Drug (IND) application, with a Phase 1 trial anticipated to begin enrollment in the second half of 2024. Rather than purely preclinical partnering, FibroGen, Inc. has already established a clinical study collaboration with Regeneron Pharmaceuticals to evaluate FG-3165 in combination with LIBTAYO®. This existing framework could be leveraged for further development or co-commercialization deals for FG-3165 and the planned 2025 IND-filing asset, FG-3175, to share development costs.

The diagnostic component, FG-3180, represents a market entry diversification. FG-3180 is a PET imaging agent being assessed as a companion diagnostic for FG-3246, with interim results expected in the second half of 2026. The strategy here is to establish FG-3180 as a standalone biomarker tool, potentially superior to CD46 IHC in prostate cancer, which would create a separate revenue stream based on diagnostic utility, independent of the therapeutic outcome of FG-3246.

Here's a snapshot of the key pipeline and financial metrics relevant to these diversification moves:

Metric/Asset	Value/Status (as of Q3 2025)	Relevance to Diversification
Cash and Equivalents	$121.1 million	Capital available for licensing in a late-stage asset.
Q3 2025 Net Loss (Continuing Ops)	$13.1 million	Target for offset via specialty pharma acquisition.
FG-3246 Phase 2 Trial Initiation	Q3 2025	Platform for expansion into other CD46-expressing tumors.
FG-3180 Assessment	Companion PET agent in Phase 2 trial	Standalone biomarker tool market entry potential.
FG-3165 Status	Phase 1 trial initiated in H2 2024	Asset for potential partnership expansion beyond existing Regeneron collaboration.
Roxadustat LR-MDS Protocol Submission	Q4 2025	Core asset progress, but diversification is needed to fund potential internal Phase 3 costs.

The immediate action items for the diversification strategy involve capital deployment and pipeline extension:

• Expand FG-3246 trials to non-mCRPC CD46-expressing solid tumors.
• Finalize the Phase 3 protocol for roxadustat in LR-MDS by Q4 2025.
• Evaluate potential late-stage asset licensing using the $121.1 million reserve.
• Develop a commercial strategy for FG-3180 as a standalone diagnostic.
• Identify acquisition targets to mitigate the $13.1 million quarterly loss.

The Regeneron collaboration on FG-3165 shows a willingness to partner on oncology assets. Finance: draft 13-week cash view by Friday.