Every 8-K that Abeona Therapeutics Inc. (ABEO) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow ABEO and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full ABEO filings page.
Abeona Therapeutics Inc. reported second quarter 2026 results centered on the commercial launch of ZEVASKYN, its autologous cell-based gene therapy for recessive dystrophic epidermolysis bullosa (RDEB). Net ZEVASKYN revenue for the quarter ended June 30, 2026 was $11.4 million, a 31% quarter-over-quarter increase from $8.7 million in the first quarter of 2026. Five patients were treated in the quarter, with revenue recognized for four treatments; since launch, 12 treatments have been completed.
The qualified treatment center (QTC) network expanded to seven sites, including recent activations at NewYork-Presbyterian/Columbia, Children’s Hospital of Philadelphia, University of Texas Medical Branch, and Cincinnati Children’s. Abeona highlighted that the Centers for Medicare & Medicaid Services granted ZEVASKYN New Technology Add-On Payment (NTAP) status effective October 1, 2026, intended to support hospital adoption for Medicare patients, who account for about 10% of RDEB patients.
R&D expenses were $5.0 million and SG&A expenses were $15.8 million in Q2 2026, both down versus Q1 2026. The company reported a net loss of $(20.2) million, or $(0.35) per share, and held $146.8 million in cash, cash equivalents and short-term investments as of June 30, 2026, compared with $191.4 million as of December 31, 2025.
Abeona Therapeutics Inc. reported results of its annual stockholder meeting held virtually on June 12, 2026. Stockholders elected Keith A. Goldan and Bernhardt G. Zeiher, M.D. as Class 1 directors to serve until the 2029 annual meeting. They approved, on an advisory basis, the compensation of named executive officers and ratified Deloitte & Touche LLP as independent registered public accounting firm for the fiscal year ending December 31, 2026. Stockholders also approved increasing shares reserved for issuance under the 2023 Equity Incentive Plan from 8,400,000 to 11,500,000. A proposed amendment to remove the advance notice provision for director nominations from the certificate of incorporation received a majority of votes cast but did not obtain the required 66 2/3% of outstanding shares and therefore was not approved.
Abeona Therapeutics Inc. reported that board member Michael Amoroso resigned from its Board of Directors effective June 11, 2026. Along with leaving the board, he also stepped down from the Board’s Nominating and Corporate Governance Committee.
The company stated that Mr. Amoroso’s resignation was for personal reasons and was not due to any disagreement with Abeona regarding its operations, policies, or practices. The filing was signed on behalf of the company by Chief Financial Officer Joseph Vazzano.
Abeona Therapeutics Inc. filed a current report to share that it has prepared an updated investor presentation. The company plans to use this presentation in meetings with investors, analysts, and other interested parties.
The investor presentation, dated June 10, 2026, is furnished as Exhibit 99.1 under Regulation FD. Abeona notes that this material is being furnished rather than filed, meaning it is not subject to certain liability provisions of the Exchange Act and is not automatically incorporated into other securities filings unless specifically referenced.
Abeona Therapeutics reported that it held a pre-Investigational New Drug (Pre-IND) meeting with the U.S. Food and Drug Administration regarding ABO-701, its engineered T-cell therapy targeting Prostate-Specific Membrane Antigen for prostate cancer. The company believes the meeting was constructive and is still aiming to submit an IND application for ABO-701 in 2027, in line with its prior timeline. Management notes there is no assurance the FDA will not request additional studies or data, or that any eventual IND submission will be accepted or allow clinical trials to begin, and highlights that development plans may change based on FDA feedback, preclinical results, manufacturing considerations, financing, and other risks described in its SEC filings.
Abeona Therapeutics reported first-quarter 2026 results highlighted by early ZEVASKYN commercialization and a new T‑cell therapy license. Net product revenue reached $8.7 million, a $6.3 million increase over the fourth quarter of 2025, driven by three ZEVASKYN patient treatments in the quarter.
Cost of sales was $2.7 million, while R&D totaled $9.6 million, including a $7.0 million upfront payment to in‑license PSMA‑SIR‑T, now ABO‑701. Selling, general and administrative expenses rose to $19.5 million as the company scaled commercial operations.
Abeona reported a net loss of $17.1 million, or $0.30 per share, compared with a $12.0 million loss a year earlier. Cash, cash equivalents and short‑term investments were $168.3 million as of March 31, 2026. The ZEVASKYN qualified treatment center network expanded to six sites, coverage policies now reach 95% of commercially insured U.S. lives, and the company plans to file an IND and begin first‑in‑human studies for ABO‑701 in the second half of 2027 while deprioritizing in‑house ophthalmology programs.
Abeona Therapeutics Inc. reported that its Board of Directors expanded from nine to ten members and appointed Keith A. Goldan as a Class 1 independent director, effective April 1, 2026, with a term expiring at the 2026 annual stockholders’ meeting. He was also named Chair of the Audit Committee, and the Board determined he meets Nasdaq independence standards. Abeona will pay him an annual cash Board fee of $50,000 and a one-time $150,000 restricted stock award that vests over one year, with eligibility for the Board’s next regular equity grant in 2027.
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 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.
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. (ABEO) furnished quarterly results information. The company reported that it issued a press release regarding its financial results for the quarter ended September 30, 2025, and furnished it under Item 2.02.
The full text of the release is included as Exhibit 99.1. As stated, the information under Item 2.02 and Exhibit 99.1 is furnished and not deemed “filed” for purposes of Section 18 of the Exchange Act, and is not incorporated by reference except as expressly set forth by specific reference.
Abeona Therapeutics, Inc. filed a Current Report on Form 8-K stating that on August 14, 2025 it issued a press release reporting its financial results for the quarter ended June 30, 2025. The press release is filed as Exhibit 99.1 to the report and a Cover Page Interactive Data File is included as Exhibit 104. The 8-K specifies that the press release and related information are incorporated as exhibits but are not deemed "filed" for purposes of Section 18 of the Exchange Act and are not incorporated by reference in other filings except by specific reference. The report is signed by CFO Joseph Vazzano.
On June 27, 2025 Abeona Therapeutics Inc. (“Abeona”) closed the previously announced sale of its Rare Pediatric Disease Priority Review Voucher (PRV) to an undisclosed buyer for $155 million in gross cash proceeds under the asset purchase agreement dated May 9, 2025. The voucher had been granted by the FDA on April 28, 2025 following approval of Abeona’s BLA for ZEVASKYN™ (prademagene zamikeracel). The transaction is reported in this Form 8-K under Item 2.01.
In a press release furnished with the filing (Exhibit 99.1) the company disclosed that, including the net PRV proceeds, unaudited cash, cash equivalents, restricted cash and short-term investments stood at approximately $225 million as of June 30, 2025. Management notes the figure is preliminary, unaudited and subject to quarter-end closing procedures; the independent auditor has not reviewed the estimate.
The agreement itself will be filed with Abeona’s forthcoming Form 10-Q. No other material liabilities, guidance changes or pro-forma financials were provided.
The sale injects substantial non-dilutive capital and materially strengthens the company’s liquidity profile while removing the PRV from Abeona’s asset base.