Castle Creek Biosciences

What Castle Creek Biosciences does

Castle Creek Biosciences is a privately held, clinical-stage biotechnology company founded in 2015 and headquartered in Exton, Pennsylvania. It operates as a portfolio company of Paragon Biosciences and is focused on developing and commercializing personalized, re-dosable gene therapies for rare genetic skin and connective tissue disorders, with its lead clinical program targeting dystrophic epidermolysis bullosa (DEB), a devastating genetic blistering disease with no FDA-approved treatments.

The company's core technology is a proprietary ex vivo autologous fibroblast platform. Patient-derived dermal fibroblasts are isolated from a small skin biopsy, cultured, and genetically modified using a self-inactivating (SIN) lentiviral vector that delivers a functional copy of the target gene (COL7A1 for DEB). The modified cells are cryopreserved as a personalized cell bank enabling re-dosing, and administered via intradermal injection into chronic wounds to restore skin integrity. Its lead candidate D-Fi (FCX-007, dabocemagene autoficel) is in a registrational Phase 3 trial (NCT06892639) and has received four FDA designations: Orphan Drug, Rare Pediatric Disease, Fast Track, and RMAT. A second asset, LV-FAH—an in vivo gene therapy for hereditary tyrosinemia type 1 (HT1)—was added via the January 2022 acquisition of Novavita Thera and is advancing toward IND submission. Manufacturing is conducted in-house at an 86,500 sq ft Exton facility with ~13,000 sq ft of cGMP space previously validated for an FDA-approved autologous cell therapy product.

Castle Creek has no commercially approved products and is therefore pre-revenue. Its business model anticipates one-time-treatment gene therapy pricing upon regulatory approval, with distribution through specialty channels typical of ultra-rare disease therapies. Capital has been raised through multiple equity rounds (including a $112.8M oversubscribed round in May 2022 and a $75M non-dilutive royalty financing from Ligand Pharmaceuticals in February 2025), plus an FDA Orphan Products Development Grant of $1.825 million in October 2021. Customer acquisition today is conducted via clinical trial enrollment and a case-by-case Expanded Access Policy, supported by partnerships with patient advocacy organizations including debra of America, EB Research Partnership, Global Genes, NORD, EveryLife Foundation, and PeDRA.

Name

Castle Creek Biosciences

Legal name

Castle Creek Biosciences, Inc.

Website

https://castlecreekbio.com

Company type

Private

Founded year

2015

Operating status

Operating

Headcount range

11–50 employees

Short description

Castle Creek Biosciences is a clinical-stage gene therapy company developing personalized, autologous fibroblast-based therapies for rare genetic skin and connective tissue disorders, with its lead candidate D-Fi in a registrational Phase 3 trial for dystrophic epidermolysis bullosa.

Ownership category

akta.pro rank

Product category

Gene Therapy / Cell Therapy

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

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

akta.pro primary industry

Gene Therapy for Rare/Monogenic Diseases (HLAAACAE)

akta.pro secondary industry

Cell Therapy Developers (Autologous) (HLAAABAA)

Keywords

• Autologous gene therapy
• Rare disease therapeutics
• Cell therapy manufacturing
• Epidermolysis bullosa treatment
• Lentiviral vector platform

Headquarters

HQ city

Exton

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Gene therapy product sales (pre-commercial): Castle Creek Biosciences is a late-stage clinical company with no commercially approved products as of the available data. The company is developing D-Fi (FCX-007) for dystrophic epidermolysis bullosa (DEB) and LV-FAH for hereditary tyrosinemia type 1 (HT1). Revenue will be generated from commercial sales of gene therapies upon regulatory approval.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels4 records

Core offering

Castle Creek Biosciences develops and manufactures autologous, personalized cell-based gene therapies for rare genetic skin and connective tissue disorders using a proprietary ex vivo platform that modifies patient-derived dermal fibroblasts with a self-inactivating lentiviral vector. Its lead candidate D-Fi (FCX-007, dabocemagene autoficel) is in a registrational Phase 3 clinical trial for dystrophic epidermolysis bullosa (DEB), with additional in vivo gene therapy candidate LV-FAH for hereditary tyrosinemia type 1 (HT1). The company operates an in-house cGMP commercial-scale manufacturing facility in Exton, Pennsylvania.

Product overview

Castle Creek Biosciences is a late-stage cell and gene therapy company developing re-dosable gene therapies. The company operates its proprietary Autologous Fibroblast Technology Platform—an ex vivo approach using patient-derived fibroblasts genetically modified with lentiviral vectors. The lead product is D-Fi (FCX-007, dabocemagene autoficel), an autologous gene therapy for dystrophic epidermolysis bullosa (DEB) currently in registrational Phase 3 clinical trial. The pipeline also includes LV-FAH, an in vivo gene therapy for hereditary tyrosinemia type 1 (HT1) acquired through the Novavita Thera acquisition. The company manufactures its investigational gene therapies in-house at its 86,500 square-foot cGMP facility in Exton, Pennsylvania.

Differentiator

Problem solved

Functional benefit

Products and services

• D-Fi (FCX-007, dabocemagene autoficel) Autologous cell-based gene therapy for dystrophic epidermolysis bullosa (DEB). Patient-derived dermal fibroblasts are genetically modified with a self-inactivating lentiviral vector carrying the COL7A1 gene, then administered via intradermal injection into chronic wounds to express functional type VII collagen (COL7) and restore anchoring fibrils at the dermal-epidermal junction. Phase 1/2 data showed 80% (8/10) of treated chronic wounds achieved at least 90% wound healing 12 weeks after first injection.
• LV-FAH In vivo gene therapy candidate for hereditary tyrosinemia type 1 (HT1), a rare liver and metabolic disease. Acquired through the Novavita Thera acquisition in January 2022 and progressing toward submission of an IND to the FDA.

Quantifiable outcome

• In Phase 1/2 clinical study (NCT02810951) of 6 RDEB patients, 80% (8/10) of treated chronic wounds demonstrated at least 90% wound healing 12 weeks after the first injection of D-Fi. None of the untreated wounds were healed.

Named customers1 record

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

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

• Novavita TheracoreStrategic or Co-development Partner · 10 January 2022Castle Creek Biosciences acquired Novavita Thera in January 2022 to expand its cell and gene therapy platform, adding in vivo capabilities for developing therapies for rare liver and metabolic diseases, including hereditary tyrosinemia type 1 (HT1). The acquisition enabled development of gene therapy LV-FAH for HT1, progressing toward an IND submission to the FDA.
• Paragon BiosciencesflagshipStrategic or Co-development PartnerCastle Creek Biosciences is a portfolio company of Paragon Biosciences, a global life science leader that creates, builds, and funds innovative biology-based companies. Paragon accelerates scientific breakthroughs to treat and cure diseases. Castle Creek is described as being built within the Paragon ecosystem, with shared resources, expertise, and strategic direction.
• debra of America (Dystrophic Epidermolysis Bullosa Research Association of America)coreStrategic or Co-development Partnerdebra of America is the only national non-profit dedicated to funding EB research and providing free services and programs for those with epidermolysis bullosa. Castle Creek collaborates with debra for patient advocacy, education, and community support. The company features patient stories courtesy of debra and references debra resources on its website.
• EB Research PartnershipcoreStrategic or Co-development PartnerEB Research Partnership is the largest non-profit dedicated to funding EB research so that children with EB can grow up to live full, pain-free lives. Castle Creek features patient stories courtesy of EB Research Partnership and collaborates with the organization on patient advocacy and awareness efforts.
• Global GenesminorStrategic or Co-development PartnerGlobal Genes is one of the leading rare disease patient advocacy organizations, with a mission to build awareness, educate the global community, and provide critical connections and resources for rare disease advocates. Castle Creek lists Global Genes as a patient advocacy resource on its rare disease pages.
• National Organization for Rare Disorders (NORD)minorStrategic or Co-development PartnerNORD provides a unified voice for people battling rare diseases. Castle Creek lists NORD as a patient advocacy resource, leveraging its rare disease day participation and educational resources for the EB and rare disease community.
• EveryLife Foundation for Rare DiseasesminorStrategic or Co-development PartnerThe EveryLife Foundation is a non-profit dedicated to empowering the rare disease patient community to advocate for impactful, science-driven legislation and policy. Castle Creek references the foundation as a resource for patients and families affected by epidermolysis bullosa.
• Pediatric Dermatology Research Alliance (PeDRA)minorStrategic or Co-development PartnerPeDRA is the research arm of the Society for Pediatric Dermatology, created in response to unmet research needs in pediatric dermatology requiring collaborative, multicenter efforts. Castle Creek references PeDRA as a resource on its patient and families page.

Scale indicators6 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Krystal Biotech: Direct competitor developing Vyjuvek (beremagene geperpavec), the FDA-approved gene therapy for dystrophic epidermolysis bullosa (DEB). Both companies target the same DEB patient population with localized gene therapy approaches, making them the most directly comparable peers in the EB space.
• Abeona Therapeutics: Develops pz-cel (prademagene zamikeracel), an autologous cell-based gene therapy for recessive DEB. Direct competitor with similar autologous approach and same target indication, competing for the same DEB market with cell-based gene therapy technology.
• Rocket Pharmaceuticals: Late-stage gene therapy company developing lentiviral vector-based therapies for rare diseases including hematological and cardiac conditions. Comparable in approach (lentiviral ex vivo gene therapy), stage (registational trials), and target market (rare monogenic diseases).
• bluebird bio: Gene therapy company with approved lentiviral-based therapies for rare diseases. Comparable in using lentiviral vector technology for rare monogenic diseases, with experience navigating FDA approval pathways for novel gene therapies.
• uniQure: Gene therapy company developing AAV-based therapies for rare diseases including Huntington's disease and hemophilia. Comparable as a late-stage gene therapy company focused on rare monogenic diseases with FDA-approved designations and similar development pathways.
• Regenxbio: Gene therapy platform company developing AAV-based therapies for rare diseases. Comparable in targeting rare genetic diseases with gene therapy approaches, and shares similar regulatory designation strategies (Orphan Drug, RMAT).

Emerging players

• BridgeBio Pharma: Rare disease focused biopharmaceutical company developing therapies for genetic diseases. Comparable in targeting rare monogenic conditions with novel therapeutic approaches, though broader in therapeutic modalities beyond gene therapy.
• CRISPR Therapeutics: Gene editing company developing CRISPR/Cas9-based therapies for rare genetic diseases including sickle cell disease and beta thalassemia. Comparable as a developer of novel genetic medicines for rare diseases, though using different technology platforms (gene editing vs. gene therapy).

Broad incumbents

• Pfizer (Gene Therapy Division): Large pharmaceutical company with gene therapy programs for rare diseases including hemophilia and Duchenne muscular dystrophy. Comparable as a developer of rare disease gene therapies with significant manufacturing capabilities and commercial infrastructure.
• Vertex Pharmaceuticals: Major biopharmaceutical company with cell and gene therapy programs including Casgevy (exa-cel) for sickle cell disease. Comparable in developing approved cell-based gene therapies and navigating complex manufacturing for rare disease treatments.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xx.com/CastleCreekBio
• LinkedInlinkedin.com/company/castlecreekbio

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Subsidiaries1 record

Funding overview

Funding rounds7 records

Investors5 records

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

M&A2 records

Investments

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

Frequently asked questions about Castle Creek Biosciences