Abeona Therapeut Stock Price, News & Analysis

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.

Abeona Therapeutics (Nasdaq: ABEO) announced on December 1, 2025 that its Compensation Committee approved inducement equity awards under Nasdaq Listing Rule 5635(c)(4) to two newly hired non-executive employees.

On November 30, 2025 the committee granted restricted stock awards covering, in the aggregate, up to 45,685 restricted shares of Abeona common stock. The awards vest one-third on each anniversary of the grant date, so each grantee’s awards become fully vested on the third anniversary, subject to continued employment.

Abeona Therapeutics (Nasdaq: ABEO) reported Q3 2025 results and operational updates on Nov 12, 2025. Key points: ZEVASKYN patient treatment now anticipated to begin in 4Q 2025 after optimization of a rapid sterility release assay and resumed biopsy collection in November 2025. Early commercial momentum includes 12 ZEVASKYN product order forms received and ~30 eligible patients identified across treatment centers, with three activated Qualified Treatment Centers.

Financials: $207.5M in cash and equivalents as of Sept 30, 2025, expected to fund operations for >two years; Q3 R&D $4.2M vs $8.9M prior year; SG&A $19.3M vs $6.4M prior year; net loss $(5.2)M vs $(30.3)M prior year. CMS established permanent HCPCS J-code J3389 effective Jan 1, 2026.

Abeona Therapeutics (Nasdaq: ABEO) will report third quarter 2025 financial results and corporate progress on a conference call on Wednesday, November 12, 2025 at 8:30 a.m. ET. The call is available by phone (877-545-0523 U.S.; 973-528-0016 international) using Entry Code 922481, and via a live, listen-only webcast.

Management will also join a fireside chat at the Stifel 2025 Healthcare Conference on Thursday, November 13, 2025 at 1:20 p.m. ET. Both webcasts will be archived on the company's Investors & Media events page for 30 days after each event.

Abeona Therapeutics (Nasdaq: ABEO) announced on November 3, 2025 that its Compensation Committee granted inducement restricted stock awards to new non-executive employees under Nasdaq Listing Rule 5635(c)(4).

On October 31, 2025, Abeona granted awards to eleven new hires covering up to 71,035 restricted shares of common stock. The awards vest one-third each year on the anniversary of the grant and are fully vested on the third anniversary, subject to continued employment.

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.

Abeona Therapeutics (Nasdaq: ABEO) appointed James A. Gow, MD, MBA, MS, MHCM as Senior Vice President, Head of Clinical Development & Medical Affairs, effective October 20, 2025.

Dr. Gow brings >20 years of industry experience in gene therapy and ophthalmology, having led programs from Phase 1 through post-marketing and contributed to FDA approvals for therapies including Xibrom, Bromday, Prolensa, Bepreve and global approvals for Xiidra. He previously held executive roles at Shire, Takeda, Novartis, Biogen and SparingVision and holds medical and multiple graduate degrees from the University of Manitoba, Cornell and Harvard.

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.