Abeona will receive a license payment and potential development, regulatory, and sales milestones, and royaltiesCLEVELAND, July 01, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that Beacon Therapeutics, an ophthalmic gene therapy company and Syncona portfolio company, has exercised its option to license Abeona's patented AAV204 capsid for use in potential gene therapies for a range of prevalent and rare retinal diseases that result in blindness. This worldwide, non-exclus ...

Core Insights - Abeona Therapeutics Inc. has been added to the U.S. small-cap Russell 2000® Index and the broad-market Russell 3000® Index, effective June 30, 2025, marking a significant milestone for the company [1][2] - The inclusion in these indexes is expected to enhance the company's visibility and attract a wider range of investors, particularly following the FDA approval of ZEVASKYN™ [2] - The Russell 3000® Index includes the 3,000 largest U.S.-traded stocks, and membership is updated annually, providing a benchmark for investment strategies [3] Company Overview - Abeona Therapeutics is a commercial-stage biopharmaceutical company focused on developing cell and gene therapies for serious diseases [4] - ZEVASKYN™ is the first autologous cell-based gene therapy approved for treating wounds in patients with recessive dystrophic epidermolysis bullosa (RDEB) [4] - The company operates a fully integrated cGMP manufacturing facility in Cleveland, Ohio, which is responsible for ZEVASKYN's commercial production [4]

Company Overview - Abeona Therapeutics Inc. is a commercial-stage biopharmaceutical company focused on developing cell and gene therapies for serious diseases [3] - The company's flagship product, ZEVASKYN™ (prademagene zamikeracel), is the first and only autologous cell-based gene therapy for treating wounds in patients with recessive dystrophic epidermolysis bullosa (RDEB) [3] - Abeona operates a fully integrated cGMP manufacturing facility in Cleveland, Ohio, which is dedicated to the commercial production of ZEVASKYN [3] Upcoming Events - The CEO, Vish Seshadri, and the Chief Commercial Officer, Madhav Vasanthavada, will participate in a fireside chat at the Jefferies Global Healthcare Conference on June 4, 2025, at 11:40 a.m. Eastern Time [1] - A live webcast of the event will be available on the Investors section of the Abeona website and will be archived for 30 days [2] Product Development - Abeona's development portfolio includes adeno-associated virus (AAV)-based gene therapies targeting ophthalmic diseases with significant unmet medical needs [3] - The company is evaluating next-generation AAV capsids to enhance tropism profiles for various severe diseases [3]

Core Insights - Abeona Therapeutics has received FDA approval for ZEVASKYN™, the first autologous cell-based gene therapy for treating wounds in patients with recessive dystrophic epidermolysis bullosa (RDEB) [1][5] - The company is transitioning to a commercial-stage entity with the launch of ZEVASKYN and has activated its first treatment center [2][4] Recent Developments - ZEVASKYN's FDA approval marks a significant milestone for RDEB patients, with the first treatment expected in Q3 2025 [5] - Abeona has secured a $155 million non-dilutive capital through the sale of its Rare Pediatric Disease Priority Review Voucher (PRV), which will fund operations for over two years [3] - The company has entered into value-based agreements with commercial payer groups, ensuring access to ZEVASKYN for approximately 100 million commercially-insured lives [5] Financial Results - As of March 31, 2025, the company reported cash and cash equivalents totaling $84.5 million, down from $98.1 million at the end of 2024 [6] - Research and development expenses increased to $9.9 million in Q1 2025 from $7.2 million in Q1 2024, primarily due to scaling up manufacturing for ZEVASKYN [7] - The net loss for Q1 2025 was $12.0 million, a significant reduction from a net loss of $31.6 million in Q1 2024 [8][14]

Core Insights - The FDA has approved ZEVASKYN as the first and only autologous cell-based gene therapy for treating wounds in patients with recessive dystrophic epidermolysis bullosa (RDEB) [1][16] - ZEVASKYN demonstrated significant wound healing and pain reduction in a pivotal Phase 3 study, with 81% of treated wounds showing 50% or more healing after six months [3][4] - The therapy will be available through Qualified Treatment Centers starting in the third quarter of 2025 [1][12] Company Overview - Abeona Therapeutics is a commercial-stage biopharmaceutical company focused on developing cell and gene therapies for serious diseases, with ZEVASKYN being a key product in its portfolio [21] - The company operates a fully integrated cGMP manufacturing facility in Cleveland, Ohio, which will support the commercial production of ZEVASKYN [21] Clinical Evidence - The pivotal Phase 3 VIITAL™ study met its co-primary efficacy endpoints, showing statistically significant healing and pain reduction in large chronic RDEB wounds [3][4] - In a Phase 1/2a study, long-term improvements in wound healing and pain reduction were observed, with a median follow-up of 6.9 years [5] Patient Support and Accessibility - Abeona Assist™ is a patient services program designed to provide personalized support, including insurance benefits and financial assistance [13] - ZEVASKYN will be accessible through specialized treatment centers recognized for their expertise in epidermolysis bullosa [12] Market Impact - The approval of ZEVASKYN is seen as a significant advancement for the RDEB community, addressing a critical unmet need for effective wound treatment [2][8] - The company received a Rare Pediatric Disease Priority Review Voucher from the FDA, which it plans to monetize [14]