ABEONA THERAPEUTICS INC. SEC Filings

Abeona Therapeutics Inc. reported that its Board approved Third Amended and Restated Bylaws, effective March 16, 2026, fully replacing bylaws adopted in July 2024. The revisions clarify how annual and special shareholder meetings can be called, postponed, rescheduled, or canceled, and expressly allow virtual meetings under Delaware law.

The bylaws eliminate the requirement to make a shareholder list available at meetings, add rules for attending meetings via remote communication, and raise the quorum requirement from one-third to 50% of shares entitled to vote. They also strengthen procedural and disclosure requirements for shareholder proposals and director nominations, including conditions for using the SEC’s universal proxy rules.

Abeona Therapeutics Inc. is now a commercial-stage cell and gene therapy company following U.S. FDA approval of ZEVASKYN® on April 28, 2025 for treating wounds in adults and children with recessive dystrophic epidermolysis bullosa (RDEB), a severe genetic skin disease with no cure.

ZEVASKYN® is the first and only FDA-approved autologous cell-based gene therapy for RDEB wounds and is manufactured at Abeona’s cGMP facility in Cleveland, Ohio. As of March 2026, four qualified U.S. treatment centers are activated, and the company has broad commercial and Medicaid coverage plus a permanent J‑code effective January 1, 2026.

The company sold a Rare Pediatric Disease Priority Review Voucher for $155.0 million, strengthening its cash position, and estimates about 750 moderate-to-severe RDEB patients in the U.S. could be eligible for ZEVASKYN®. Abeona is also advancing AAV-based gene therapies for XLRS (ABO‑503), Stargardt disease (ABO‑504), and ADOA (ABO‑505) using its AIM™ capsid platform and has multiple out‑licensing and capsid-licensing deals supporting additional milestone and royalty potential.

Abeona Therapeutics reported its first full year of commercialization in 2025 with a sharp move to profitability driven by a one-time asset sale. Total revenue was $5.8 million, including $2.4 million in net product revenue from ZEVASKYN and $3.4 million in license and other revenues.

The company recorded a loss from operations of $89.4 million as it ramped commercial infrastructure, but net income reached $71.2 million, or $1.34 per basic share, mainly due to a $152.4 million gain from selling a Priority Review Voucher for $155.0 million. Cash, cash equivalents and short-term investments were $191.4 million as of December 31, 2025. ZEVASKYN, approved by the FDA in April 2025, saw its first commercial treatment in December, with additional biopsies and treatments underway in early 2026.

ABEO reported a Form 144 notice of proposed sales of Common Stock. The filing lists 2,000 Restricted Stock Units tied to equity compensation with a 03/15/2026 date and names Stifel Nicolaus & Company Inc. as broker. It also records a prior sale of 18,666 Common Stock by Joseph Vazzano on 01/22/2026.

Abeona Therapeutics Inc.’s Chief Financial Officer Joseph Walter Vazzano reported an open-market sale of 785 shares of common stock. The shares were sold at $4.76 each on the transaction date to cover tax obligations associated with the vesting of restricted stock awards. After this transaction, he directly holds 567,775 shares of Abeona common stock.

Abeona Therapeutics Inc. filed a report sharing a business update on the commercial launch of its FDA-approved gene therapy ZEVASKYN for recessive dystrophic epidermolysis bullosa (RDEB). Launch activities began in late 2025, with the first patient treated in December before a scheduled facility shutdown.

Manufacturing resumed in late January 2026, with multiple biopsies collected, one additional patient treatment completed, and further biopsies scheduled this quarter. Access is expanding, with coverage policies published by major commercial payers representing about 80 percent of commercially insured lives, full Medicaid coverage, and a permanent CMS HCPCS J-code J3389 effective January 1, 2026.

Abeona Therapeutics Inc. received an amended Schedule 13G/A from Adage Capital Management and related reporting persons indicating they no longer beneficially own any shares of Abeona common stock. As of December 31, 2025, each reporting person reports 0 shares and 0% ownership, with no voting or dispositive power.

The filing confirms that these institutional and individual holders now own 5 percent or less of Abeona’s common stock and that any securities previously acquired were held in the ordinary course of business, not for the purpose of influencing control of the company.

A shareholder of ABEO plans to sell 20,070 shares of common stock under Rule 144. The planned sale, through broker Stifel Nicolaus & Company Inc., has an aggregate market value of $102,168.00 and is listed for execution on or about 02/02/2026 on the Nasdaq.

The seller previously acquired 36,101 shares of common stock on 01/31/2026 via restricted stock units granted as equity compensation by the issuer and paid in equity rather than cash.

Abeona Therapeutics director Christine Berni Silverstein reported a tax-related stock sale. On February 2, 2026, she sold 20,070 shares of common stock at a weighted average price of $5.0906 per share. After this transaction, she beneficially owned 137,722 shares, held directly.

The filing notes the sale was made to cover tax obligations arising from the vesting of restricted stock awards, indicating the transaction was tied to equity compensation rather than a discretionary open-market liquidation. The price range for the sales was between $5.09 and $5.12 per share.