What Pierre Fabre Pharmaceuticals does

Pierre Fabre Pharmaceuticals Inc. is a US pharmaceutical subsidiary of Pierre Fabre Laboratories, established in February 2024 and headquartered in Secaucus, New Jersey. The company develops and intends to commercialize breakthrough therapies in oncology and rare diseases, operating a pipeline of six assets that spans allogeneic T-cell immunotherapy, protein replacement therapy, and targeted small-molecule and biologic modalities. The lead asset, tabelecleucel (EBVALLO), is an allogeneic T-cell therapy for relapsed/refractory EBV-positive post-transplant lymphoproliferative disorder (EBV+ PTLD), an ultra-rare disease affecting approximately 500 US patients annually with no FDA-approved treatment options. The BLA was acquired from Atara Biotherapeutics in November 2025, received a Complete Response Letter in January 2026, and was subsequently granted a regulatory path forward via a Type A meeting with the FDA in May 2026. The broader pipeline includes ER004 (Phase II, in-utero protein replacement for XLHED, partnered with EspeRare), Exarafenib (Phase I, pan-RAF inhibitor for NRAS mutant melanoma, acquired from Kinnate), PFL-002/VERT-002 (Phase I, c-MET degrader for NSCLC, acquired from Vertical Bio), and PFL-721 and PFL-241 (Phase I, mutant-specific EGFR inhibitors from Antares).

The company operates a sales-led go-to-market model targeting healthcare providers and specialty treatment centers through an enterprise field sales organization staffed by commercial leaders with prior experience at Kite Pharma, Novartis Oncology, and Eisai. Revenue mechanics are expected to follow a one-time pharmaceutical product sales model contingent on regulatory approval; no US revenue is currently reported and pricing is not publicly disclosed. The business model relies on in-licensing and acquisition to build pipeline depth (oncology accounts for over 80% of R&D investment), supplemented by an Expanded Access Program for investigational medicines and companion diagnostic development in partnership with Foundation Medicine. As the US arm of Pierre Fabre Laboratories — a 60-year-old global healthcare company operating in 43 countries with 10,000+ employees and over $3 billion in revenue — Pierre Fabre Pharmaceuticals benefits from the parent's patient-capital ownership structure (majority-owned by the Pierre Fabre Foundation) while pursuing biotech-speed development and commercialization.

Name

Pierre Fabre Pharmaceuticals

Legal name

Pierre Fabre Pharmaceuticals Inc.

Website

https://pierrefabrepharmaceuticals.com

Company type

Private

Founded year

2024

Operating status

Operating

Headcount range

1–10 employees

Short description

Pierre Fabre Pharmaceuticals Inc. is the US pharmaceutical subsidiary of Pierre Fabre Laboratories, developing and commercializing precision oncology and rare disease therapies, with a lead allogeneic T-cell therapy (tabelecleucel) for EBV+ PTLD and a pipeline spanning cell therapy, protein replacement, and targeted oncology.

Ownership category

akta.pro rank

Product category

Specialty Oncology Pharmaceuticals

NAICS

Pharmaceutical Preparation Manufacturing (325412), Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Pharmaceutical Preparations (2834), Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Cell Therapy Enabling Technologies (gene editing, cell engineering, delivery methods) (HLAAABAL)

akta.pro secondary industry

Monoclonal Antibody Therapeutics (mAbs) (HLAAAAAA)

Keywords

• Oncology therapeutics
• Rare disease therapies
• Cell therapy products
• Specialty pharmaceuticals
• Targeted cancer therapy

Headquarters

HQ city

Secaucus

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Marketing or Sales, Supply Chain, Operations, Infrastructure

Revenue model

1. Pharmaceutical Product Sales: Revenue generated from the sale of pharmaceutical products including oncology drugs, rare disease treatments, and cell therapies. The company is working towards commercialization of tabelecleucel (EBVALLO) and other pipeline products in the US market.

Go-to-market motion2 records

Distribution channels2 records

Marketing channels4 records

Core offering

Pierre Fabre Pharmaceuticals is the US pharmaceutical subsidiary of Pierre Fabre Laboratories, developing and commercializing breakthrough therapies in oncology and rare diseases. Its pipeline spans allogeneic T-cell immunotherapy (tabelecleucel for EBV+ PTLD), protein replacement therapy (ER004 for XLHED), and targeted small molecule and antibody therapies (Exarafenib, PFL-002/VERT-002, PFL-721, PFL-241) for various hematologic and solid tumor indications.

Product overview

Pierre Fabre Pharmaceuticals is a US pharmaceutical subsidiary of Pierre Fabre Laboratories focused on delivering breakthrough therapies in oncology and rare diseases. The company operates a pipeline consisting of one product in registration (tabelecleucel/EBVALLO for EBV+ PTLD), one product in Phase II (ER004 for XLHED), and four products in Phase I development (Exarafenib, PFL-002/VERT-002, PFL-721, PFL-241 for various oncology indications). The portfolio centers on allogeneic T-cell immunotherapy, targeted therapies, and protein replacement therapies addressing high unmet medical needs in hematology and solid tumors.

Differentiator

Problem solved

Functional benefit

Products and services

• Tabelecleucel (EBVALLO) Allogeneic T-cell therapy in which immune cells from a healthy donor are used to target and destroy EBV-infected B cells, administered via IV injection for patients with relapsed or refractory Epstein-Barr virus positive post-transplant lymphoproliferative disorder (EBV+ PTLD). Clinicaltrials.gov ID: NCT03394365.
• ER004 In-utero protein replacement therapy designed to replace the function of endogenous ectodysplasin A1 (EDA1), which is a protein key to the normal development of ectodermal structures in fetuses, administered via intra-amniotic injection for hypohidrotic ectodermal dysplasia (XLHED). Clinicaltrials.gov ID: NCT04980638.
• Exarafenib Pan-RAF small molecule inhibitor that targets BRAF class I, II, and III and NRAS alterations, which are known drivers of disease in patients with melanoma, administered orally for NRAS mutant melanoma. Clinicaltrials.gov ID: NCT04913285.
• PFL-002 / VERT-002 Monoclonal antibody acting as a degrader of c-MET, a known driver of disease in patients with MET mutations or amplification in non-small cell lung cancer (NSCLC).
• PFL-721 (formerly STX-721) Mutant-specific EGFR inhibitor that is highly selective for exon 20 insertion mutations, which account for about 4-10% of all EGFR mutations in non-small cell lung cancer (NSCLC).
• PFL-241 (formerly STX-241)

Quantifiable outcome

• 47.7% objective response rate across 86 patients in Phase 3 ALLELE study
• +1 more outcomes

Named customers1 record

Segments4 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Seven partnerships are on record, tiered flagship, core and minor.

• Atara BiotherapeuticsflagshipStrategic or Co-development Partner · 1 November 2025Pierre Fabre Pharmaceuticals acquired the Biologics License Application (BLA) for tabelecleucel from Atara Biotherapeutics in November 2025. Atara transferred the BLA and IND to PFP, with PFP now leading regulatory interactions with the FDA. The partnership involves collaboration on the ongoing Phase 3 ALLELE study and potential resubmission for FDA approval of tabelecleucel for EBV+ PTLD.
• Antares TherapeuticscoreStrategic or Co-development Partner · 1 August 2025Partnership with Antares Therapeutics for PFL-721 (formerly STX-721) and PFL-241 (formerly STX-241), two mutant-specific EGFR inhibitors for NSCLC with exon 20 insertions and C797S mutations respectively.
• EspeRarecoreStrategic or Co-development Partner · 1 April 2025Partnership with EspeRare for ER004, a protein replacement therapy for hypohidrotic ectodermal dysplasia (XLHED). ER004 is an in-utero therapy designed to replace the function of endogenous ectodysplasin A1 (EDA1), which is key to normal development of ectodermal structures in fetuses. First patient enrolled in Edelife trial in April 2022.
• Kinnate BiopharmacoreOEM/ Whitelabel/ Licensing Partner · 1 March 2024Pierre Fabre and Kinnate entered into an Asset Purchase Agreement for Exarafenib in March 2024. Exarafenib is a pan-RAF small molecule inhibitor targeting BRAF class I, II, and III and NRAS alterations for NRAS mutant melanoma.
• Foundation MedicineminorStrategic or Co-development Partner · 1 November 2023Collaboration with Foundation Medicine to develop companion diagnostics in non-small cell lung cancer, announced November 2023.
• VernalisminorStrategic or Co-development Partner · 1 September 2023Drug discovery collaboration in oncology with Vernalis, announced September 2023.
• Vertical BiocoreOEM/ Whitelabel/ Licensing Partner · 1 September 2023Acquisition of Vertical Bio and its innovative targeted therapy candidate PFL-002/VERT-002 for patients with non-small cell lung cancer with MET alteration, announced September 2023.

Scale indicators7 records

Recent moves8 records

Expansion highlights6 records

Direct peers

• AlloVir: Allogeneic T-cell therapy developer targeting viral diseases including post-transplant viral infections. Direct peer in allogeneic cell therapy for transplant-related viral diseases, and a former employer of Pierre Fabre's Head of Technical Operations.
• Viracta Therapeutics: Developing therapies for EBV-positive malignancies including EBV+ PTLD. Direct competitive overlap with Pierre Fabre Pharmaceuticals' lead asset tabelecleucel in the same ultra-rare indication.
• Adaptimmune Therapeutics: Clinical-stage cell therapy company developing engineered TCR-T cell therapies for solid tumors. Comparable as a cell therapy developer targeting oncology indications including NSCLC.
• Iovance Biotherapeutics: Leading commercial-stage cell therapy company with FDA-approved tumor-infiltrating lymphocyte (TIL) therapies. Comparable as a US-headquartered commercial cell therapy company building specialty oncology infrastructure.
• Atara Biotherapeutics: Originated tabelecleucel and transferred the BLA to Pierre Fabre Pharmaceuticals in November 2025. Directly comparable as an allogeneic T-cell therapy developer focused on EBV-driven diseases and oncology.
• Marker Therapeutics: Clinical-stage immuno-oncology company developing multi-tumor-associated antigen (multiTAA)-specific T-cell therapies for virus-associated cancers including EBV+ PTLD, competing in the same EBV+ cell therapy space.

Broad incumbents

• Bristol Myers Squibb: Global oncology major with a broad cell therapy, immuno-oncology, and targeted therapy portfolio. Comparable as a large incumbent whose therapies overlap with Pierre Fabre's pipeline indications, and a previous employer of Pierre Fabre's CEO and patient affairs VP.
• Kite Pharma (Gilead Sciences): Established CAR-T cell therapy leader (Yescarta, Tecartus) within Gilead. Pierre Fabre Pharmaceuticals' CEO previously led US commercial functions at Kite, making it a key reference point for cell therapy commercialization know-how.
• Novartis Oncology: Global oncology leader with established targeted therapies and the CAR-T therapy Kymriah. Pierre Fabre's CEO, CFO, and General Counsel all held senior roles at Novartis, and its cell/gene therapy finance team origin is a key reference point.

Regional players

• Servier: French-headquartered global pharmaceutical company with a strong oncology focus including targeted therapies. Comparable as a European-headquartered pharma with US expansion ambitions and a focus on specialty oncology and rare diseases.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/pierre-fabre-pharmaceuticals-inc

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Pierre Fabre Pharmaceuticals