US WorldMeds

What US WorldMeds does

US WorldMeds (USWM, LLC) is a privately held specialty pharmaceutical company headquartered in Louisville, Kentucky, founded in 2001 and operating with 51-100 employees. The company develops, licenses, and commercializes pharmaceutical products targeting rare and challenging conditions with high unmet medical need, primarily in hematology and oncology. Its commercial portfolio spans FDA-approved therapies including IWILFIN (eflornithine), the first and only oral maintenance therapy for high-risk neuroblastoma; TECELRA (afamitresgene autoleucel), the first engineered T-cell therapy approved for a solid tumor cancer (synovial sarcoma); REVONTO (dantrolene) for malignant hyperthermia; and SEVENFACT (recombinant factor VIIa) for hemophilia, the latter distributed via subsidiary Hema Biologics.

The company's underlying technology platform centers on autologous engineered T-cell immunotherapy using the SPEARHEAD platform to redirect patient T-cells against tumor antigens (MAGE-A4, NY-ESO-1). TECELRA is administered as a personalized single infusion engineered from each patient's own cells, while IWILFIN is an oral twice-daily maintenance therapy taken for up to two years. The acquired Adaptimmune pipeline adds three additional TCR T-cell programs (afami-cel, lete-cel, uza-cel) targeting multiple solid tumor indications, and eflornithine is being studied in additional pediatric oncology settings including medulloblastoma.

US WorldMeds generates revenue through direct specialty pharmaceutical sales via specialty pharmacy networks, healthcare provider dispensing, patient assistance programs, and expanded access programs, operating exclusively within the US market. The company employs an enterprise field sales model serving hospitals, specialty treatment centers, and clinical research consortia. Its customer segments are highly specialized, defined by rare disease patient populations (high-risk neuroblastoma, synovial sarcoma, malignant hyperthermia, hemophilia, and previously opioid withdrawal before the March 2025 LUCEMYRA divestiture to BioCorRx). Distribution relies on direct relationships with oncology centers and academic research networks, including a strategic partnership with the Beat Childhood Cancer Research Consortium representing over 50 hospitals.

Name

US WorldMeds

Legal name

USWM, LLC

Website

https://usworldmeds.com

Company type

Private

Founded year

2001

Operating status

Operating

Headcount range

51–100 employees

Short description

US WorldMeds is a privately held Louisville, Kentucky-based specialty pharmaceutical company that develops, licenses, and commercializes FDA-approved therapies for rare diseases, primarily in oncology and hematology, including engineered T-cell immunotherapies (TECELRA) and oral maintenance therapies (IWILFIN) serving patients with synovial sarcoma, high-risk neuroblastoma, hemophilia, and malignant hyperthermia.

Ownership category

akta.pro rank

Product category

Specialty Pharmaceuticals

NAICS

Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Rare Oncology & Hematologic Malignancy Therapies (HLAIAIAC)

akta.pro secondary industries

Oncology & Hematology Pharmaceuticals (HLAIAAAC), Specialty Injectable & Infusion Therapies (Cross-therapeutic) (HLAIACAO), Specialty Care Pharmaceuticals (HLAIAAAB)

Keywords

• Specialty pharmaceuticals
• Rare disease drugs
• Engineered cell therapy
• Oncology therapeutics
• Pediatric cancer treatment

Headquarters

HQ city

Louisville

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, Marketing or Sales, Supply Chain, Personnel, Operations

Revenue model

1. Specialty Pharmaceutical Product Sales: US WorldMeds generates revenue through the sale of specialty pharmaceutical products including approved therapies for rare diseases, bleeding disorders, and oncology. Products are distributed through specialty pharmacies and healthcare providers.
2. Acquisition Revenue Potential: Acquired engineered T-cell therapy portfolio including FDA-approved TECELRA and three investigational therapies from Adaptimmune Therapeutics for $55 million upfront plus potential milestone payments of up to $30 million.

Go-to-market motion1 record

Distribution channels4 records

Marketing channels7 records

Core offering

US WorldMeds is a privately held, Kentucky-based specialty pharmaceutical company that develops, licenses, and commercializes therapies for patients with rare and challenging conditions. Its portfolio includes FDA-approved products for high-risk neuroblastoma (IWILFIN), synovial sarcoma (TECELRA, an engineered autologous T-cell therapy), malignant hyperthermia (REVONTO), and hemophilia (SEVENFACT), along with a pipeline of investigational T-cell therapies for solid tumors.

Product overview

US WorldMeds is a specialty pharmaceutical company that develops, licenses, and brings to market unique healthcare products designed to improve the lives of patients with challenging conditions and unmet medical needs. The company's portfolio includes FDA-approved therapies for oncology and cell therapy (TECELRA for synovial sarcoma, IWILFIN for high-risk neuroblastoma), hemophilia treatments (REVONTO, SEVENFACT), and a robust pipeline of investigational T-cell therapies (afami-cel, lete-cel, uza-cel) and eflornithine-based treatments for various pediatric cancers. The company is committed to rare disease research with a focus on hematology and oncology therapeutic areas.

Differentiator

Problem solved

Functional benefit

Brands

• IWILFIN: Oral maintenance therapy tablet for high-risk neuroblastoma
• REVONTO
• SEVENFACT
• TECELRA

Products and services

• TECELRA (afamitresgene autoleucel) A genetically modified autologous T-cell immunotherapy engineered to recognize and attack cancer cells expressing the MAGE-A4 antigen, administered as a single infusion for adult and pediatric patients 12 years and older with unresectable or metastatic synovial sarcoma who meet HLA-A*02:01P and MAGE-A4 eligibility criteria.
• IWILFIN (eflornithine) The first and only FDA-approved oral maintenance therapy for high-risk neuroblastoma, indicated to reduce the risk of relapse in adult and pediatric patients who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy; taken orally twice daily for two years.
• REVONTO A pharmaceutical product for the treatment of malignant hyperthermia, a potentially life-threatening pharmacogenetic disorder of skeletal muscle calcium regulation triggered by certain anesthesia agents.
• SEVENFACT (activated recombinant human factor VIIa) A recombinant factor VIIa hemostatic product for management of bleeding disorders including hemophilia, distributed in the United States and its territories by Hema Biologics, LLC under exclusive license from LFB S.A.
• LUCEMYRA (lofexidine) The only FDA-approved non-opioid medication for the mitigation of opioid withdrawal symptoms in adults undergoing abrupt opioid discontinuation; LUCEMYRA assets were divested to BioCorRx Inc. in March 2025.

Quantifiable outcome

• 43.8% overall response rate with 3.6% complete response rate in SPEARHEAD-1 study of 137 patients with synovial sarcoma
• +3 more outcomes

Named customers2 records

Segments5 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Six partnerships are on record, tiered minor, core and major.

• University of KentuckyminorStrategic or Co-development Partner · 19 February 2026US WorldMeds donated laboratory equipment valued at $1.34 million to the University of Kentucky, sourced from a former cell-therapy facility in Cambridge, Massachusetts. The contribution includes high-value scientific instruments and laboratory supplies, coordinated through UK Innovate in partnership with the University of Louisville and LifeSciKY.
• Adaptimmune TherapeuticscoreOEM/ Whitelabel/ Licensing Partner · 11 August 2025US WorldMeds completed acquisition of Adaptimmune Therapeutics' cell therapy portfolio including FDA-approved TECELRA and three investigational therapies (afami-cel, lete-cel, uza-cel) for $55 million in upfront cash plus potential milestone payments of up to $30 million. Approximately half of Adaptimmune's US-based employees associated with the divested programs were offered roles at US WorldMeds.
• BioCorRx Inc.minorChannel Partner/ Reseller/ Distributor · 31 March 2025BioCorRx Inc. completed an Asset Purchase Agreement in March 2025 to acquire Lucemyra assets from USWM, LLC.
• Beat Childhood Cancer Research ConsortiumcoreStrategic or Co-development Partner · 14 December 2023US WorldMeds partnered with the Beat Childhood Cancer Research Consortium at Penn State University, which conducted preclinical and clinical research to advance IWILFIN (eflornithine). The consortium represents over 50 hospitals offering childhood cancer clinical trials through a collaborative network.
• FEMA (Federal Emergency Management Agency)majorStrategic or Co-development Partner · 9 July 2020US WorldMeds partnered with FEMA and Healthcare Ready to bring urgently needed opioid withdrawal medication (LUCEMYRA) to communities in need during the COVID-19 pandemic. This partnership addressed the intersection of the opioid epidemic and COVID-19 crisis for underserved communities.
• Healthcare ReadymajorStrategic or Co-development Partner · 9 July 2020Healthcare Ready, a nonprofit that strengthens healthcare supply chains through collaboration with public health and private sectors, partnered with US WorldMeds and FEMA to facilitate donation and distribution of LUCEMYRA to communities impacted by COVID-19.

Scale indicators6 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Adaptimmune Therapeutics: Original developer of TECELRA, afami-cel, lete-cel, and uza-cel. US WorldMeds acquired this TCR T-cell portfolio from Adaptimmune in August 2025, making it the most direct platform and product peer.
• Iovance Biotherapeutics: Commercial-stage cell therapy company focused on tumor-infiltrating lymphocyte (TIL) therapies for solid tumors, including lifileucel. Directly comparable as a focused solid-tumor cell therapy company with FDA-approved autologous products.

Broad incumbents

• Bristol-Myers Squibb: Owns Breyanzi and Abecma CAR-T therapies and a large oncology pipeline. Broad incumbent competing in the same engineered cell therapy space for solid and hematologic tumors.
• Gilead Sciences (Kite Pharma): Cell therapy leader via Kite (Yescarta, Tecartus). A large established player with overlapping autologous cell therapy capabilities, broader oncology footprint, and significantly greater commercial scale.
• Novartis: Developed Kymriah, the first FDA-approved CAR-T therapy. Competes broadly in oncology cell therapy and rare hematology/oncology with far greater financial and commercial resources.
• Jazz Pharmaceuticals: Specialty pharmaceutical company with significant rare oncology and hematology franchises (e.g., Rylaze, Vyxeos, Erwinaze). Comparable as a mid-to-large specialty pharma commercializing rare and oncology therapies.
• Swedish Orphan Biovitrum (Sobi): Specialty pharma focused on rare diseases, including hematology (hemophilia) and immunology. Comparable via SEVENFACT-style hemophilia distribution and the rare-disease specialty pharma business model.
• Recordati Rare Diseases: Specialty pharmaceutical group with a dedicated rare diseases unit, including hematology and oncology assets. Comparable as an established rare-disease specialty pharma commercializing niche therapies.

Emerging players

• Crispr Therapeutics: Clinical-stage gene-editing and cell therapy company developing autologous and allogeneic cell therapies for oncology and rare diseases. Comparable as a cell therapy peer focused on engineered immune cell platforms.

Others

• Hema Biologics (US WorldMeds subsidiary): US WorldMeds' own subsidiary and exclusive US distributor of SEVENFACT (recombinant factor VIIa) under license from LFB S.A. Included as a direct channel peer in hemophilia/bleeding disorders distribution.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/usworldmeds
• Facebookfacebook.com/USWorldMeds
• LinkedInlinkedin.com/company/usworldmeds

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 records

Funding overview

Funding rounds3 records

Investors3 records

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

M&A1 record

Investments

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

Frequently asked questions about US WorldMeds