Abeona Therapeutics® Provides Business Update Highlighting Building Momentum in ZEVASKYN® Commercial Launch Abeona Therapeutics (Nasdaq: ABEO) reported building momentum in the commercial launch of FDA-approved ZEVASKYN (prademagene zamikeracel) for RDEB.After optimizing a release assay in 2025, launch activities began Q4 2025; first patient treated in December before a scheduled facility shutdown. Manufacturing resumed late January 2026 with multiple biopsies collected, one patient treated, ongoing runs, and more biopsies scheduled this quarter. Major commercial payers covering ~80% of commercial lives and all Medicaid programs have published policies. CMS established permanent HCPCS J-code J3389, effective January 1, 2026, to support billing and reimbursement.

#ABEO Abeona Therapeutics® Provides Business Update Highlighting Building Momentum in ZEVASKYN® Commercial Launch

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Abeona Therapeutics® Announces Date of Fourth Quarter / Full Year 2025 Financial Results and Participation in Upcoming 2026 Leerink Global Healthcare Conference Abeona Therapeutics (Nasdaq: ABEO) announced a conference call for its Q4 and full year 2025 results on Tuesday, March 17, 2026 at 8:30 a.m. ET, available by phone and webcast.Management will also participate in a fireside chat at the 2026 Leerink Global Healthcare Conference on March 10, 2026 at 8:40 a.m. ET; both webcasts will be archived for 30 days on the company’s Investors & Media events page.

#ABEO Abeona Therapeutics® Announces Date of Fourth Quarter / Full Year 2025 Financial Results and Participation in Upcoming 2026 Leerink Global Healthcare Conference

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Abeona Therapeutics (Nasdaq: ABEO) designates UTMB as new ZEVASKYN gene therapy treatment center in Texas Abeona Therapeutics names UTMB in Galveston a Qualified Treatment Center for ZEVASKYN, expanding access to its FDA-approved RDEB gene therapy in Texas.

#ABEO Abeona Therapeutics® Announces New Qualified Treatment Center for ZEVASKYN® in Texas

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Abeona Therapeutics® Announces First Patient Treatment with ZEVASKYN® Gene Therapy Abeona Therapeutics (Nasdaq: ABEO) announced the first commercial patient treatment with FDA‑approved ZEVASKYN (prademagene zamikeracel) for wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB).The treatment was administered at Lucile Packard Children’s Hospital Stanford in Palo Alto, CA on Dec 8, 2025, and Abeona said additional patients are already scheduled for treatment in the new year. The company highlighted its Abeona Assist patient support program offering insurance benefit navigation, financial assistance, and travel/logistics help.

#ABEO Abeona Therapeutics® Announces First Patient Treatment with ZEVASKYN® Gene Therapy

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#ABEO: First Patient Treated with Zevaskyn® Pushed to 4Q25 Following Assay Optimization buff.ly/sgDUgVR

Abeona Therapeutics® Reports Third Quarter 2025 Financial Results and Corporate Updates - First anticipated ZEVASKYN ® patient treatment shifted to 4Q 2025 following implementation of optimized release assay - - Strong and growing patient demand and treatment site network, along with broad market access provide foundation for sustainable commercial success - - $207.5M in cash, cash

#ABEO Abeona Therapeutics® Reports Third Quarter 2025 Financial Results and Corporate Updates

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Abeona Therapeutics® Announces Permanent J-Code for ZEVASKYN® (prademagene zamikeracel) Abeona Therapeutics (Nasdaq: ABEO) announced that the Centers for Medicare and Medicaid Services has established a permanent HCPCS J-code J3389 for ZEVASKYN (prademagene zamikeracel), its autologous gene‑modified cellular sheet for wounds in adult and pediatric recessive dystrophic epidermolysis bullosa (RDEB).The J-code, defined as “Topical administration, prademagene zamikeracel, per treatment,” becomes effective January 1, 2026. Abeona said the product‑specific code will simplify claims and reimbursement, support hospital adoption, and improve patient access across public and private payers.

#ABEO Abeona Therapeutics® Announces Permanent J-Code for ZEVASKYN® (prademagene zamikeracel)

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Abeona Therapeutics® Announces ABO-503 Gene Therapy for X-linked Retinoschisis (XLRS) Selected by FDA for Rare Disease Endpoint Advancement (RDEA) Pilot Program Abeona Therapeutics Inc. (Nasdaq: ABEO), a commercial-stage biopharmaceutical company developing cell and gene

#ABEO Abeona Therapeutics® Announces ABO-503 Gene Therapy for X-linked Retinoschisis (XLRS) Selected by FDA for Rare Disease Endpoint Advancement (RDEA) Pilot Program

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Abeona Therapeutics® and Children's Hospital Colorado Announce Newest Treatment Center for ZEVASKYN® Gene Therapy Abeona Therapeutics (Nasdaq: ABEO) and Children's Hospital Colorado announced on October 8, 2025 that Children’s Colorado is activated as a Qualified Treatment Center (QTC) for ZEVASKYN (prademagene zamikeracel) gene-modified cellular sheets.ZEVASKYN is FDA-approved to treat wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). Children’s Colorado has completed QTC start-up activities and may begin patient identification and scheduling. Abeona highlighted patient support through Abeona Assist with contact options for access and financial assistance.

#ABEO Abeona Therapeutics® and Children's Hospital Colorado Announce Newest Treatment Center for ZEVASKYN® Gene Therapy

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#ABEO: First Patient Treatment with Zevaskyn Expected in 3Q25… buff.ly/r13NQci

Abeona Therapeutics® Reports Second Quarter 2025 Financial Results and Corporate Updates Abeona Therapeutics (Nasdaq: ABEO) reported significant Q2 2025 financial results and milestones, highlighted by the FDA approval and launch of ZEVASKYN™, the first autologous cell-based gene therapy for RDEB wound treatment. The company reported strong financial position with $226M in cash and investments, and achieved net income of $108.8M ($2.07 per basic share) in Q2 2025.The ZEVASKYN launch shows promising momentum with the first patient treatment expected in Q3 2025 and multiple patients in the pipeline. The company has secured broad insurance coverage, including positive policies from major payers covering approximately 60% of RDEB lives. Abeona plans to scale up supply capacity to 10 patients per month by mid-2026 and projects profitability in 1H 2026.

#ABEO Abeona Therapeutics® Reports Second Quarter 2025 Financial Results and Corporate Updates

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ZEVASKYN™ Gene Therapy Now Available at New Qualified Treatment Center in San Francisco Bay Area Abeona Therapeutics (Nasdaq: ABEO) has activated a new Qualified Treatment Center (QTC) for ZEVASKYN, its FDA-approved gene therapy treatment, at Lucile Packard Children's Hospital Stanford. ZEVASKYN, approved in April 2025, is the first and only FDA-approved therapy to treat recessive dystrophic epidermolysis bullosa (RDEB) wounds with a single application.The activation follows a decade-long research collaboration between Abeona and Stanford Medicine. The treatment is now available at both Stanford and Lurie Children's Hospital of Chicago. To support patient access, Abeona offers Abeona Assist™, a comprehensive support program providing insurance benefits assistance, financial support options, and travel logistics help.

#ABEO ZEVASKYN™ Gene Therapy Now Available at New Qualified Treatment Center in San Francisco Bay Area

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Bio-Techne's Simple Western Enables Breakthrough FDA Approval for Rare Skin Disease Gene Therapy 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.

#TECH #ABEO Bio-Techne's Simple Western™ Technology Utilized in Recent FDA Approval of ZEVASKYN™ Cell-Based Gene Therapy

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Abeona Cashes In $155M From Priority Review Voucher Sale, Secures 2-Year Runway Without Dilution Fresh $155M PRV sale bolsters Abeona's war chest to $225M, funding ZEVASKYN launch and 2+ years of operations. See growth projections and launch timeline.

#ABEO Abeona Therapeutics® Closes Sale of Rare Pediatric Disease Priority Review Voucher for $155 Million

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Abeona Therapeutics® Announces Option Exercise by Beacon Therapeutics for Novel AAV204 Capsid for Ophthalmology Gene Therapy Abeona Therapeutics (Nasdaq: ABEO) announced that Beacon Therapeutics has exercised its option to license Abeona's patented AAV204 capsid for potential gene therapies targeting retinal diseases. The worldwide, non-exclusive license follows their July 2024 evaluation agreement.The AAV204 capsid, from the AIM™ capsid library licensed from the University of North Carolina at Chapel Hill, has demonstrated high macular and optic nerve transduction levels after para-retinal administration and can facilitate transduction of both inner and outer retina after intravitreal administration in mice and non-human primates.Under the agreement, Beacon can use AAV204 for up to five gene or ophthalmology disease targets. Abeona will receive an undisclosed upfront license payment, potential development, regulatory, and sales milestone payments, and tiered royalties on worldwide net sales of licensed products incorporating AAV204.

#ABEO Abeona Therapeutics® Announces Option Exercise by Beacon Therapeutics for Novel AAV204 Capsid for Ophthalmology Gene Therapy

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Abeona Therapeutics Added to Russell 2000: Major Milestone After Recent FDA Drug Victory Fresh off ZEVASKYN's FDA approval, Abeona joins $10.6T Russell indexes ecosystem. See how this dual catalyst positions the biotech firm for institutional growth.

#ABEO Abeona Therapeutics® added to Membership of U.S. Small-cap Russell 2000® Index and Broad-market Russell 3000® Index

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Abeona Therapeutics® Announces Publication in The Lancet of Phase 3 VIITAL™ Study Data in Recessive Dystrophic Epidermolysis Bullosa Abeona Therapeutics (Nasdaq: ABEO) announced the publication of Phase 3 VIITAL study results in The Lancet for ZEVASKYN™, their FDA-approved gene therapy for treating RDEB wounds. The study demonstrated significant efficacy with 81% of treated wounds showing ≥50% healing compared to 16% in control wounds after 24 weeks.The trial involved 11 patients with 43 pairs of large chronic wounds. Key results showed 65% of treated wounds achieved ≥75% healing versus 7% of control wounds. Patients experienced significant pain reduction (-3.1 in treated vs -0.9 in control wounds). The therapy demonstrated a favorable safety profile with no serious treatment-related adverse events.ZEVASKYN is the first and only FDA-approved autologous cell-based gene therapy for treating recessive dystrophic epidermolysis bullosa (RDEB) wounds. The company expects to treat its first commercial patient in Q3 2025.

#ABEO Abeona Therapeutics® Announces Publication in The Lancet of Phase 3 VIITAL™ Study Data in Recessive Dystrophic Epidermolysis Bullosa

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Olivier Estèves Pdg Abeo : "Nous affichons notre confiance devant les perspectives de l'année qui s'ouvre".
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#ABEO: Sells Priority Review Voucher for $155 Million… buff.ly/Xl56I7Q

Abeona Therapeutics® Reports First Quarter 2025 Financial Results and Corporate Updates Abeona Therapeutics (NASDAQ: ABEO) reported Q1 2025 financial results and major milestones. The company received FDA approval for ZEVASKYN™, the first autologous cell-based gene therapy for treating RDEB wounds. Following approval, Abeona activated its first qualified treatment center at Lurie Children's Hospital, with the first patient expected in Q3 2025. The company entered into a sales agreement for its priority review voucher for $155 million. Financial highlights include: cash position of $84.5 million as of March 31, 2025, Q1 net loss of $12.0 million ($0.24 per share), and R&D expenses of $9.9 million. Notably, about 30 patients have started registering in the Abeona Assist program, and the company has secured value-based agreements with payers covering approximately 100 million commercially-insured lives.

#ABEO Abeona Therapeutics® Reports First Quarter 2025 Financial Results and Corporate Updates

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UPDATE -- Abeona Therapeutics® and Lurie Children's Open First Center for ZEVASKYN™ Gene Therapy to Treat Wounds in Painful Skin Disorder 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.

#ABEO UPDATE -- Abeona Therapeutics® and Lurie Children's Open First Center for ZEVASKYN™ Gene Therapy to Treat Wounds in Painful Skin Disorder

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First-Ever Gene Therapy Treatment Center Opens for Devastating Skin Disease RDEB - What Patients Need to Know Groundbreaking ZEVASKYN therapy for RDEB now available at Lurie Children's Hospital. First treatments begin Q3 2025. Learn about patient eligibility and support programs.

#ABEO Abeona Therapeutics® and Lurie Children's Open First Center for ZEVASKYNTM Gene Therapy to Treat Wounds in Painful Skin Disorder

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Abeona Therapeutics® Enters into Agreement to Sell Priority Review Voucher for $155 Million Abeona Therapeutics (NASDAQ: ABEO) has announced an agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for $155 million. The company received the PRV following FDA approval of ZEVASKYN™ (prademagene zamikeracel) on April 28, 2025. According to CFO Joe Vazzano, the proceeds will provide sufficient cash for over two years of operating expenses without requiring additional capital, excluding ZEVASKYN sales revenue.ZEVASKYN is scheduled to become available for patient treatment in Q3 2025, with the company projecting profitability by early 2026. The PRV sale transaction remains subject to standard closing conditions, including Hart-Scott Rodino Antitrust Improvements Act waiting period expiration. Stifel led the financial advisory role, with Jefferies also serving as advisor.

#ABEO Abeona Therapeutics® Enters into Agreement to Sell Priority Review Voucher for $155 Million

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#ABEO: Zevaskyn™ Approved by FDA; Raising Valuation to $11… buff.ly/RyD4NFw

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U.S. FDA Approves ZEVASKYN™ (prademagene zamikeracel), the First and Only Cell-Based Gene Therapy for Patients with Recessive Dystrophic Epidermolysis Bullosa (RDEB) - ZEVASKYN fills a critical need for people living with RDEB, a debilitating dermatological condition with no cure - - Approval based on the pivotal Phase 3 VIITAL™ study, showing ZEVASKYN resulted in significant wound healing and pain reduction after a single treatment with a favorable safety

#ABEO U.S. FDA Approves ZEVASKYN™ (prademagene zamikeracel), the First and Only Cell-Based Gene Therapy for Patients with Recessive Dystrophic Epidermolysis Bullosa (RDEB)

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