Abeona Expands ZEVASKYN Network as RDEB Launch Gains Momentum  Yahoo Finance

Abeona Therapeutics is prioritizing long-term infrastructure and patient access instead of rapid initial revenue growth for its rare-disease therapy, ZEVASKYN. The company is navigating complex manufacturing and reimbursement hurdles while scaling its operational capacity to meet the demands of a $3

TUESDAY, April 29, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has approved Zevaskyn (prademagene zamikeracel) for patients with the rare, genetic skin disorder recessive dystrophic...

- ZEVASKYN fills a critical need for people living with RDEB, a debilitating dermatological condition with no cure - - Approval based on the pivotal Phase...

Lurie Children’s Becomes First Treatment Center for Zevaskyn Gene Therapy in Patients with RDEB  Dermatology Times

Abeona has won FDA approval for Zevaskyn, setting up a commercial challenge to Krystal Biotech in the rare skin disease market.

Abeona Therapeutics (NASDAQ: ABEO) and Lurie Children's Hospital announced the activation of the first Qualified Treatment Center (QTC) for ZEVASKYN, a groundbreaking gene therapy for treating wounds in patients with recessive dystrophic epidermolysis bullosa (RDEB). ZEVASKYN, recently FDA-approved on April 29, 2025, is the first and only autologous cell-based gene therapy for RDEB wounds treatment with a single application.Lurie Children's, a top-ranked hospital caring for over 150 epidermolysis bullosa patients, will begin patient identification with treatments expected to start in Q3 2025. The first patient is scheduled for biopsy in July 2025 and treatment in August 2025. To support patient access, Abeona has launched Abeona Assist, a comprehensive support program offering insurance benefits guidance, financial assistance, and travel logistics support.

Abeona Therapeutics' Zevaskyn has been approved in the US as a treatment for the rare skin disorder recessive dystrophic epidermolysis bullosa (DEB).

Zevaskyn is the only FDA-approved product to treat recessive dystrophic epidermolysis bullosa wounds with a single application.

Zevaskyn, which Abeona priced at $3.1 million, treats epidermolysis bullosa. It will compete with a gene therapy from Krystal Biotech that is off to a strong sales start.

Reported Wednesday, Sep 16 - 7:32am EDT (TheFly subscription required to read more.)

Bio-Techne's Simple Western platform enables breakthrough in RDEB treatment, providing crucial data for FDA approval of first-in-class gene therapy. Learn more.

Almost half of all novel medications approved by the U.S. FDA are orphan drugs. Below is the list of important regulatory dates for all orphan drugs for 2025.

Groundbreaking ZEVASKYN therapy for RDEB now available at Lurie Children's Hospital. First treatments begin Q3 2025. Learn about patient eligibility and support programs.

© 2025 Abeona Therapeutics Inc. All rights reserved. US-COM-ZEV-250033 03/25

Abeona Therapeutics (Nasdaq: ABEO) reported Q2 2026 net ZEVASKYN revenue of $11.4 million, a 31% quarter-over-quarter increase from $8.7 million. Five patients were treated, with revenue recognized for four; since launch, 12 ZEVASKYN treatments have been completed. The ZEVASKYN qualified treatment center network expanded to seven U.S. sites, including NewYork-Presbyterian/Columbia, Children’s Hospital of Philadelphia, UTMB and Cincinnati Children’s.ZEVASKYN received CMS NTAP status effective October 1, 2026 under the FY 2027 IPPS Final Rule. Q2 R&D expenses were $5.0 million, SG&A $15.8 million, and net loss $(20.2) million or $(0.35) per share. Cash, cash equivalents and short-term investments totaled $146.8 million as of June 30, 2026, according to Abeona Therapeutics.

Descriptive, non-directional summary of recent AI analyses.

RDEB has no cure and causes severe skin wounds; ZEVASKYN uses a patient’s own cells to produce collagen, with Abeona offering insurance and travel support.