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trade policy, including current or future tariffs or other trade restrictions.
This Form 10-K includes our trademarks, trade names and service marks, such as ZEVASKYN and AIM , which are protected under applicable intellectual property laws and are the property of Abeona Therapeutics Inc.
Solely for convenience, trademarks, trade names and service marks referred to in this report appear without the and symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the right of the applicable licensor to these trademarks, trade names and service marks.
We do not intend our use or display of other parties trademarks, trade names or service marks to imply, and such use or display should not be construed to imply, a relationship with, or endorsement or sponsorship of us by, these other parties.
Food and Drug Administration ( FDA ) approved ZEVASKYN (prademagene zamikeracel) gene-modified cellular sheets, also known as ZEVASKYN , as the first and only autologous cell-based gene therapy for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa ( RDEB ), a serious and debilitating genetic skin disease.
There is no cure for RDEB, and ZEVASKYN is the only FDA-approved product to treat RDEB wounds with a single surgical application.
ZEVASKYN was granted Orphan Drug and Rare Pediatric Disease designations by the FDA ZEVASKYN is manufactured at our current Good Manufacturing Practices ( cGMP ) manufacturing facility in Cleveland, Ohio.
Treatments are available through ZEVASKYN qualified treatment centers, a network of centers that are selected based on their expertise in cell and gene therapy and trained to administer ZEVASKYN .
As of March 2026, we have activated 4 qualified treatment centers and are in discussions with additional centers as we continue to expand the ZEVASKYN qualified treatment network.
The Company s development portfolio also features adeno-associated virus ( AAV )-based gene therapies designed to treat ophthalmic diseases with high unmet need using novel AIM capsids.
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These statements include statements about: the outcome and timing of the U.S.
Our lead clinical program is for prademagene zamikeracel ( pz-cel ), an autologous, cell-based gene therapy currently in development for recessive dystrophic epidermolysis bullosa ( RDEB ).
Pz-cel has been granted Orphan Drug and Rare Pediatric Disease ( RPD ) designations by the U.S.
Food and Drug Administration ( FDA ) and Orphan Drug Designation by the European Medicines Agency ( EMA ).
We plan to continue development of adeno-associated virus ( AAV ) based gene therapies designed to treat ophthalmic diseases with high unmet need using the novel AIM capsids exclusively licensed from the University of North Carolina at Chapel Hill ( UNC ) and developed internally through our AAV vector research programs.
Abeona s novel, next-generation AAV capsids are being evaluated to improve tropism profiles for a variety of devastating diseases.
Our Mission and Strategy Abeona is a clinical-stage biopharmaceutical company developing cell and gene therapies for life-threatening diseases.
Our lead clinical program is pz-cel, autologous, COL7A1 gene-corrected epidermal sheets, an investigational product currently in development for RDEB.
In November 2022, we announced positive top-line data from the VIITAL study evaluating the efficacy, safety and tolerability of pz-cel.
In September 2023, we submitted a Biologics License Application ( BLA ) for pz-cel to the FDA.