Epidermolysis Bullosa Pipeline 2025: FDA Approvals and Clinical Trials Landscape with MOA and ROA Highlights by DelveInsight | RegeneRx Biopharma, BridgeBio Pharma, Berg Pharma, Holostem Terapie Avanz

Epidermolysis Bullosa Pipeline 2025: FDA Approvals and Clinical Trials Landscape with MOA and ROA Highlights by DelveInsight | RegeneRx Biopharma, BridgeBio Pharma, Berg Pharma, Holostem Terapie Avanz
Epidermolysis Bullosa pipeline constitutes 20+ key companies continuously working towards developing 21+ Epidermolysis Bullosa treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

 

Epidermolysis Bullosa Pipeline Insight, 2025 report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Epidermolysis Bullosa Market.

 

The Epidermolysis Bullosa Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.

 

Some of the key takeaways from the Epidermolysis Bullosa Pipeline Report:

  • Companies across the globe are diligently working toward developing novel Epidermolysis Bullosa treatment therapies with a considerable amount of success over the years. Epidermolysis Bullosa Key players such as – Berg Pharma, Holostem Terapie Avanzate, Aegle Therapeutics, RegeneRx Biopharmaceuticals, BridgeBio Pharma, InMed Pharmaceuticals, Fibrocell Science, Krystal Biotech, and others, are developing therapies for the Epidermolysis Bullosa treatment

  • Epidermolysis Bullosa Emerging therapies such as – BPM31510, HOLOGENE-17,AGLE102, RGN-137, PTR-01, INM-755, Dabocemagene autoficel, VYJUVEK, and others are expected to have a significant impact on the Epidermolysis Bullosa market in the coming years.

  • In September 2025, Krystal Biotech announced that the U.S. FDA has approved a new label update for beremagene geperpavec-svdt (B-VEC/YJUVEK). The update expands the eligible patient population to include dystrophic epidermolysis bullosa (DEB) patients from birth. Patients and caregivers can now administer the therapy and manage wound dressings at home independently. In addition, wound dressings can be removed during the next dressing change instead of waiting the previously required 24 hours.

  • In April 2025, Abeona Therapeutics Inc. (Nasdaq: ABEO) has announced that the U.S. Food and Drug Administration (FDA) has approved ZEVASKYN™ (pronounced ‘ZEE-vah-skin’)—prademagene zamikeracel—as the first and only autologous cell-based gene therapy for treating wounds in both adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB), a severe and disabling genetic skin disorder. Currently, there is no cure for RDEB, and ZEVASKYN is the only FDA-approved therapy offering wound treatment through a single application.

  • In April 2025, DEBRA Research gGmbH, a German non-profit committed to supporting research and drug development for individuals with Epidermolysis Bullosa (EB), is partnering with Viking Global Investors, CureEB, EBMRF, and Stanford University to invest in Nova Anchora LLC. Nova Anchora is an early-stage, preclinical biotechnology company focused on creating innovative protein therapies for EB. This funding will help advance the company’s lead candidate, NvA-011, through preclinical stages and toward IND (Investigational New Drug) readiness.

  • In September 2024, In a small real-world study, treatment with Janus kinase (JAK) inhibitors, including upadacitinib and baricitinib, demonstrated greater effectiveness than dupilumab in alleviating itching and skin lesions in individuals with epidermolysis bullosa pruriginosa (EBP). Among five patients on dupilumab, only two achieved a 50% reduction in itching, with none experiencing total relief. In comparison, all five patients treated with JAK inhibitors who had measurable itch scores reported complete relief from itching.

 

Epidermolysis Bullosa Overview

Epidermolysis bullosa is a rare genetic disorder characterized by extremely fragile skin that is prone to blistering and tearing from minor friction or trauma. It is caused by mutations in genes responsible for producing proteins that help to anchor the layers of the skin together. As a result, individuals with EB experience painful blisters and sores on their skin, as well as in the mucous membranes lining the mouth, esophagus, and other organs.

 

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Epidermolysis Bullosa Pipeline Therapeutics Assessment

  • Epidermolysis Bullosa Assessment by Product Type

  • Epidermolysis Bullosa By Stage and Product Type

  • Epidermolysis Bullosa Assessment by Route of Administration

  • Epidermolysis Bullosa By Stage and Route of Administration

  • Epidermolysis Bullosa Assessment by Molecule Type

  • Epidermolysis Bullosa by Stage and Molecule Type

 

DelveInsight’s Epidermolysis Bullosa Report covers around 21+ products under different phases of clinical development like

  • Late-stage products (Phase III)

  • Mid-stage products (Phase II)

  • Early-stage product (Phase I)

  • Pre-clinical and Discovery stage candidates

  • Discontinued & Inactive candidates

  • Route of Administration

 

Further Epidermolysis Bullosa product details are provided in the report. Download the Epidermolysis Bullosa pipeline report to learn more about the emerging Epidermolysis Bullosa therapies

 

Emerging Epidermolysis Bullosa Drugs Under Different Phases of Clinical Development Include:

  • BPM31510: Berg Pharma

  • HOLOGENE-17: Holostem Terapie Avanzate

  • AGLE102: Aegle Therapeutics

  • RGN-137: RegeneRx Biopharmaceuticals

  • PTR-01: BridgeBio Pharma

  • INM-755: InMed Pharmaceuticals

  • Dabocemagene autoficel: Fibrocell Science

  • VYJUVEK: Krystal Biotech

 

Epidermolysis Bullosa Pipeline Analysis:

The Epidermolysis Bullosa pipeline report provides insights into

  • The report provides detailed insights about companies that are developing therapies for the Epidermolysis Bullosa treatment with aggregate therapies developed by each company for the same.

  • It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Epidermolysis Bullosa Treatment.

  • Epidermolysis Bullosa key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.

  • Epidermolysis Bullosa Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.

  • Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Epidermolysis Bullosa market.

The report is built using data and information traced from the researcher’s proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.

 

Download Sample PDF Report to know more about Epidermolysis Bullosa drugs and therapies

 

Epidermolysis Bullosa Pipeline Market Drivers

  • Improving Healthcare Infrastructure

  • Demand for New and Effective Drugs

 

Epidermolysis Bullosa Pipeline Market Barriers

  • Currently no cure for all types of Epidermolysis Bullosa (DEB)

  • Making a diagnosis for a genetic or rare disease is often challenging

 

Scope of Epidermolysis Bullosa Pipeline Drug Insight

  • Coverage: Global

  • Key Epidermolysis Bullosa Companies: Berg Pharma, Holostem Terapie Avanzate, Aegle Therapeutics, RegeneRx Biopharmaceuticals, BridgeBio Pharma, InMed Pharmaceuticals, Fibrocell Science, Krystal Biotech, and others

  • Key Epidermolysis Bullosa Therapies: BPM31510, HOLOGENE-17,AGLE102, RGN-137, PTR-01, INM-755, Dabocemagene autoficel, VYJUVEK, and others

  • Epidermolysis Bullosa Therapeutic Assessment: Epidermolysis Bullosa current marketed and Epidermolysis Bullosa emerging therapies

  • Epidermolysis Bullosa Market Dynamics: Epidermolysis Bullosa market drivers and Epidermolysis Bullosa market barriers

Request for Sample PDF Report for Epidermolysis Bullosa Pipeline Assessment and clinical trials

 

Table of Contents

1

Epidermolysis Bullosa Report Introduction

2

Epidermolysis Bullosa Executive Summary

3

Epidermolysis Bullosa Overview

4

Epidermolysis Bullosa- Analytical Perspective In-depth Commercial Assessment

5

Epidermolysis Bullosa Pipeline Therapeutics

6

Epidermolysis Bullosa Late Stage Products (Phase II/III)

7

Epidermolysis Bullosa Mid Stage Products (Phase II)

8

Epidermolysis Bullosa Early Stage Products (Phase I)

9

Epidermolysis Bullosa Preclinical Stage Products

10

Epidermolysis Bullosa Therapeutics Assessment

11

Epidermolysis Bullosa Inactive Products

12

Company-University Collaborations (Licensing/Partnering) Analysis

13

Epidermolysis Bullosa Key Companies

14

Epidermolysis Bullosa Key Products

15

Epidermolysis Bullosa Unmet Needs

16

Epidermolysis Bullosa Market Drivers and Barriers

17

Epidermolysis Bullosa Future Perspectives and Conclusion

18

Epidermolysis Bullosa Analyst Views

19

Appendix

20

About DelveInsight

 

 

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.

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