Welcome to our dedicated page for Abeona Therapeut news (Ticker: ABEO), a resource for investors and traders seeking the latest updates and insights on Abeona Therapeut stock.
Abeona Therapeutics Inc. (Nasdaq: ABEO) is a commercial-stage biopharmaceutical company developing cell and gene therapies for serious diseases, with a primary focus on recessive dystrophic epidermolysis bullosa (RDEB)ZEVASKYN® (prademagene zamikeracel), which Abeona describes as the first and only autologous cell-based gene therapy for the treatment of wounds in adult and pediatric patients with RDEB.
On this page, readers can follow ABEO news related to ZEVASKYN’s commercial rollout, including activation of new Qualified Treatment Centers, initial patient treatments, and updates on manufacturing and product release processes at the company’s cell and gene therapy cGMP facility in Cleveland, Ohio. Press releases also cover developments in reimbursement and market access, such as the assignment of a permanent HCPCS J-code (J3389) by the Centers for Medicare and Medicaid Services (CMS) and coverage decisions by commercial health plans.
Abeona’s news flow additionally features corporate and pipeline updates, including quarterly financial results, participation in investor conferences, and progress in its AAV-based gene therapy programs, such as the ABO-503 program for X-linked retinoschisis (XLRS) selected for the FDA’s Rare Disease Endpoint Advancement Pilot Program. Management appointments and employee equity inducement grants under Nasdaq Listing Rule 5635(c)(4) are also regular topics.
Investors, clinicians, and other stakeholders can use this ABEO news feed to review the company’s latest disclosures on commercial performance indicators, regulatory and payer milestones, treatment site expansion, and strategic pipeline initiatives in gene therapy.
Abeona Therapeutics (Nasdaq: ABEO) announced that its ABO-503 gene therapy for X-linked retinoschisis (XLRS) was selected for the FDA Rare Disease Endpoint Advancement (RDEA) Pilot Program on October 13, 2025. Participation provides enhanced FDA communication to accelerate development and validation of product-specific novel efficacy endpoints for the XLRS program.
ABO-503 uses a functional RS1 gene in AIM capsid AAV204, has shown preclinical structural and functional retinal improvements in an XLRS mouse model, and Abeona expects to complete IND-enabling studies in H2 2026.
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.
Abeona Therapeutics (Nasdaq: ABEO) announced the granting of equity awards to ten new non-executive employees as inducement for their employment. The awards, approved under Nasdaq Listing Rule 5635(c)(4), consist of 19,420 restricted shares of Abeona common stock in aggregate.
The shares will vest in three equal annual installments, with full vesting occurring on the third anniversary of the Grant Date, contingent on continued employment. The grants were approved by Abeona's Board of Directors Compensation Committee on September 30, 2025.
Abeona Therapeutics (Nasdaq: ABEO) announced the granting of equity awards to seven new non-executive employees. The awards, approved under Nasdaq Listing Rule 5635(c)(4), consist of 15,500 restricted shares of Abeona common stock in aggregate.
The restricted stock awards will vest in three equal annual installments, with full vesting occurring on the third anniversary of the August 31, 2025 grant date, contingent upon continued employment with the company.
Abeona Therapeutics (Nasdaq: ABEO) has announced its participation in two major investor conferences in September 2025. The company will participate in a fireside chat at the Cantor Global Healthcare Conference on September 4, 2025 at 10:20 a.m. ET, and deliver a company presentation at the H.C. Wainwright 27th Annual Global Investment Conference on September 9, 2025 at 2:00 p.m. ET.
Both events will include investor meetings and will be webcast live on the company's investor relations website, with replays available for a limited time.
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.
Abeona Therapeutics (Nasdaq: ABEO) announced the granting of equity awards to 14 new non-executive employees. The Compensation Committee approved restricted stock awards totaling 34,679 shares on July 30, 2025, as employment inducement under Nasdaq Listing Rule 5635(c)(4).
The vesting schedule is structured over three years, with one-third of the shares vesting annually on the grant date anniversary. Full vesting will occur on the third anniversary, contingent on continued employment.
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.
Bio-Techne (NASDAQ: TECH) announced that its Simple Western™ Technology was instrumental in supporting the FDA approval of ZEVASKYN™, the first autologous cell-based gene therapy for recessive dystrophic epidermolysis bullosa (RDEB), developed by Abeona Therapeutics.
The Simple Western platform was chosen for its superior capabilities in detecting and quantifying Collagen VII, a critical protein for ZEVASKYN's potency testing. The technology's advantages include picogram-level sensitivity, reproducibility, and minimal sample requirements, making it essential for GMP-compliant lot release testing of both viral vector and cell therapy components.
The platform successfully overcame complex analytical challenges in standardization and assay development, particularly in evaluating Collagen VII's tertiary structure under non-denaturing conditions.
Abeona Therapeutics (Nasdaq: ABEO) has completed the sale of its Rare Pediatric Disease Priority Review Voucher (PRV) for $155 million on June 27, 2025. The company's cash position, including PRV proceeds, reached approximately $225 million as of June 30, 2025.
The PRV was awarded by the FDA in April 2025 following the approval of ZEVASKYN™, the first FDA-approved autologous cell-based gene therapy for treating wounds in patients with recessive dystrophic epidermolysis bullosa. The company expects to begin patient treatments with ZEVASKYN in Q3 2025 and projects profitability by early 2026.
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