Abeona Therapeutics Inc. develops and commercializes cell and gene therapies for serious diseases. Its updates center on ZEVASKYN (prademagene zamikeracel), an autologous cell-based gene therapy for wounds in adults and pediatric patients with recessive dystrophic epidermolysis bullosa, including qualified treatment center activations, commercial launch activity, manufacturing and patient-treatment progress.
Company news also covers financial results, corporate progress, employee inducement equity awards under Nasdaq rules, board and committee changes, and development work involving AAV-based gene therapies and next-generation AAV capsids for ophthalmic and other serious diseases.
Abeona Therapeutics (ABEO) granted equity awards covering up to 7,200 restricted common shares to two new non-executive employees on September 30, 2026.
The Compensation Committee approved the employment inducement awards under Nasdaq Listing Rule 5635(c)(4). One-third is scheduled to vest on each grant-date anniversary, with full vesting on the third anniversary, subject to continued employment on each vesting date.
Abeona Therapeutics (ABEO) announced that Ultragenyx has received U.S. FDA approval for FAYUVI™ (rebisufligene etisparvovec-hopf), also known as UX111, a gene therapy for treating Sanfilippo syndrome type A (MPS IIIA), a rare progressive neurodegenerative lysosomal storage disorder.
FAYUVI originated from research by Drs. Haiyan Fu and Douglas McCarty at The Ohio State University and Nationwide Children's Hospital and was advanced into clinical development by Abeona as ABO-102. In 2022, Abeona out-licensed the program to Ultragenyx, granting global development and commercialization rights. Abeona’s CEO described the approval as an extraordinary milestone for patients and families who previously lacked effective therapeutic options and credited multi-institution collaboration and Abeona’s foundational data for supporting the program’s progress. The approval triggers a value-creation event for Abeona, which is eligible for commercial milestone payments and royalties tied to future FAYUVI product sales under its agreement with Ultragenyx.
Abeona Therapeutics (ABEO) has activated University of Florida Health in Gainesville as its eighth Qualified Treatment Center for administering ZEVASKYN gene-modified cellular sheets.
UF Health is now the sole treatment center for ZEVASKYN across the Southeastern United States, expanding access for eligible adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). UF Health has begun patient identification and onboarding and is collaborating with Abeona to support treatment access. ZEVASKYN is described as the first and only autologous cell sheet-based gene therapy approved for treating RDEB wounds and has shown clinically meaningful wound healing and pain reduction after a single surgical application.
Abeona Therapeutics (ABEO) will participate in three investor conferences in September 2026, featuring fireside chats, a company presentation, and investor meetings.
Events include the Cantor Global Healthcare Conference on September 9, the H.C. Wainwright Global Investment Conference on September 15, and the Morgan Stanley Global Healthcare Conference on September 16, with live webcasts and limited-time replays via Abeona's investor website.
Abeona Therapeutics (Nasdaq: ABEO) reported that its Compensation Committee granted equity awards to new non-executive employees under Nasdaq Listing Rule 5635(c)(4). On August 31, 2026, Abeona approved restricted stock awards covering up to an aggregate of 13,300 shares of common stock for five new hires. These inducement awards vest in three equal annual installments on each anniversary of the grant date, contingent on the employees’ continued employment, and are intended as a material inducement to join the company.
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.
Abeona Therapeutics (Nasdaq: ABEO) will host a conference call on Thursday, August 13, 2026 at 8:30 a.m. ET to discuss its second quarter 2026 financial results and provide a corporate update. Results will be released in a press release before the call, with live access via phone and webcast, plus a 30-day archived replay on the company’s investor website.
Abeona Therapeutics (Nasdaq: ABEO) announced that the Centers for Medicare & Medicaid Services has granted New Technology Add-On Payment (NTAP) status for ZEVASKYN (prademagene zamikeracel) under the Fiscal Year 2027 Hospital Inpatient Prospective Payment System Final Rule. NTAP provides supplemental reimbursement above standard hospital payments for technologies that, according to CMS criteria, demonstrate substantial clinical improvement over existing alternatives.
ZEVASKYN is described as the first and only autologous cell sheet-based gene therapy to treat wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). According to Abeona Therapeutics, ZEVASKYN has shown clinically meaningful wound healing and pain reduction after a single surgical application, and the company highlights NTAP as supporting Medicare patient access, treatment center economics, and reimbursement alongside its permanent J-code.
Abeona Therapeutics (Nasdaq: ABEO) granted equity awards to new non-executive employees as material inducements to employment under Nasdaq Listing Rule 5635(c)(4). On July 31, 2026, Abeona’s Compensation Committee approved an aggregate of up to 10,800 restricted common shares, vesting in three equal annual installments over three years, subject to continued employment.
Abeona Therapeutics (Nasdaq: ABEO) announced that Cincinnati Children’s has been activated as the seventh Qualified Treatment Center (QTC) for administering ZEVASKYN (prademagene zamikeracel), an autologous gene-modified cellular sheet therapy for wounds in patients with recessive dystrophic epidermolysis bullosa (RDEB).
Cincinnati Children’s, described as one of the largest epidermolysis bullosa centers in the US, can now offer ZEVASKYN to adult and pediatric RDEB patients. Abeona highlighted its Abeona Assist program, which provides personalized support for insurance, financial assistance, and travel logistics. The release also reiterates ZEVASKYN’s mechanism, indication, clinically meaningful wound healing and pain reduction after a single surgical application, and key safety information, including risks of allergic reactions, potential cancer risk, infection transmission, and common side effects such as procedural pain and itching.