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ABEONA THERAPEUTICS INC. (ABEO)

Abeona Therapeutics Inc. is a biopharmaceutical company in the clinical development stage, focused on creating innovative gene and cell therapies to address severe and uncommon genetic diseases. Its leading program, EB-101, an autologous gene-corrected cell therapy, is presently in a Phase III clinical trial for treating recessive dystrophic epidermolysis bullosa. The company's pipeline also features several other promising therapies: ABO-102, an adeno-associated virus (AAV)-based gene therapy for Sanfilippo syndrome type A. ABO-201, intended for CLN3 disease. ABO-401, developed to treat cystic fibrosis. ABO-50X, aimed at various genetic eye disorders. Additionally, Abeona is advancing AAV-based gene therapy solutions through its proprietary AIM vector platform. The company, which was founded in 1974 and is headquartered in New York, New York, changed its name to Abeona Therapeutics Inc. in June 2015, having previously been known as PlasmaTech Biopharmaceuticals, Inc.

Sector: Pharmaceutical Preparations

Industry: Biotechnology

Abeona Therapeutics Inc. logo

Abeona Therapeutics Inc.

NASDAQ:ABEOHealthcare
-4.61%$4.35
AH$4.41+1.38%vs close
Mkt Cap$248.75M
Float49.02M
O/S57.18M
Vol
$ Vol
RVOL
Inst Own69.0%
SI35.1%
Earnings
Dilution
Phase Distribution
13 lead-sponsored trials·3 active·7 completed
Phase 1/22
Phase 22
Phase 34
Phase 42
Not applicable3
(6 more as collaborator)
Status Overview
Not yet recruiting1
Recruiting2
Active, not recruiting1
Completed7
Stopped2

Trials need funding. See this company's dilution risk and cash position.

Clinical Trials
Sponsor role
Status
Phase
  • Phase 4
    Completed

    A Study to Evaluate the Efficacy of MuGard for the Amelioration of Oral Mucositis in Head and Neck Cancer Patients

    MuGard, Control Rinse

    Oral Mucositis

    Enrollment
    120
    Start
    Jan 2011
    Primary Completion
    Apr 2013
    Completion
    May 2013
    NCT01283906
  • Phase 4
    Not yet recruiting

    Phase 4 Master Protocol for Patients Prescribed Prademagene Zamikeracel for the Treatment of Wounds

    Non-conforming pz-cel surgical application to RDEB wounds, Pz-cel surgical application to DEB wounds

    Epidermolysis Bullosa (EB), Recessive Dystrophic Epidermolysis Bullosa (RDEB) +1

    Enrollment
    100
    Start
    Nov 2026est.
    Primary Completion
    Nov 2031est.
    Completion
    Jul 2032est.
    NCT07717736
  • Phase 3
    Completed

    MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers

    ofloxacin, MSI-78

    Diabetic Foot Ulcers

    Enrollment
    584
    Start
    Aug 1994
    Primary Completion
    Jul 1996
    Completion
    Jul 1996
    NCT00563394
  • Phase 3
    Completed

    MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers

    ofloxacin, MSI-78

    Diabetic Foot Ulcers

    Enrollment
    342
    Start
    Aug 1994
    Primary Completion
    Jul 1996
    Completion
    Jul 1996
    NCT00563433
  • Phase 3
    Completed

    Phase 3, Open-label Clinical Trial of EB-101 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)

    EB-101

    Epidermolysis Bullosa, Recessive Dystrophic Epidermolysis Bullosa

    Enrollment
    11
    Start
    Jan 2020
    Primary Completion
    Oct 2022
    Completion
    Oct 2022
    NCT04227106
  • Phase 3
    Active, not recruiting

    A Phase 3b Study for the Treatment of Dystrophic Epidermolysis Bullosa (DEB) in New and Previously EB-101 Treated Patients

    EB-101 Surgical application of RDEB wounds

    Epidermolysis Bullosa, Recessive Dystrophic Epidermolysis Bullosa +1

    Enrollment
    12
    Start
    Apr 2023
    Primary Completion
    Sep 2025est.
    Completion
    Sep 2025est.
    NCT05725018
  • Phase 2
    Completed

    A Trial of the Safety and Efficacy of EcoNail™ in the Treatment of Fungus Infections of the Great Toenail

    EcoNail™ (econazole 5%/SEPA® 18% nail lacquer)

    Onychomycosis

    Enrollment
    40
    Start
    Sep 2006
    Primary Completion
    Jun 2008
    Completion
    Jun 2008
    NCT00385502
  • Phase 2
    Completed

    Study to Determine the Effects Treatment With Amlexanox 0.5% Oral Rinse Solution on Oral Mucositis Associated With Radiation Therapy for Cancer of the Head and Neck Region

    amlexanox, Vehicle rinse

    Oral Mucositis

    Enrollment
    58
    Start
    Feb 2000
    Primary Completion
    -
    Completion
    Jun 2001
    NCT01083875
  • Phase 1/2
    Completed

    Gene Transfer for Recessive Dystrophic Epidermolysis Bullosa

    LZRSE-Col7A1 Engineered Autologous Epidermal Sheets

    Epidermolysis Bullosa Dystrophica, Epidermolysis Bullosa

    Enrollment
    12
    Start
    Oct 2010
    Primary Completion
    Mar 2022
    Completion
    Mar 2022
    NCT01263379
  • Phase 1/2
    Terminated

    Gene Transfer Clinical Trial for Mucopolysaccharidosis (MPS) IIIB

    rAAV9.CMV.hNAGLU

    Mucopolysaccharidosis Type 3 B

    Enrollment
    11
    Start
    Oct 2017
    Primary Completion
    Apr 2022
    Completion
    Apr 2022
    NCT03315182
  • Observational
    Terminated

    A Long-term Follow-up Study of Patients With MPS IIIB Treated With ABO-101

    ABO-101

    Mucopolysaccharidosis III-B

    Enrollment
    1
    Start
    Oct 2020
    Primary Completion
    Apr 2022
    Completion
    Apr 2022
    NCT04655911
  • Observational
    Enrolling by invitation

    A Long-Term Extension Study for Participants Previously Treated With EB-101 for the Treatment of RDEB

    EB-101

    RDEB

    Enrollment
    22
    Start
    Feb 2021
    Primary Completion
    Feb 2036est.
    Completion
    Aug 2036est.
    NCT05708677
  • Observational
    Recruiting

    A Long-Term Safety Follow-up Registry for Patients Who Received Treatment With Prademagene Zamikeracel for Recessive Dystrophic Epidermolysis Bullosa (RDEB) in the Post-Marketing Setting

    Prademagene Zamikeracel

    Recessive Dystrophic Epidermolysis Bullosa

    Enrollment
    250
    Start
    Jul 2025
    Primary Completion
    Apr 2045est.
    Completion
    Apr 2045est.
    NCT07700966