Abeona Therapeutics INC 8-K filings

Abeona Therapeutics announced second quarter 2026 financial results, highlighting a 31% sequential increase in ZEVASKYN net revenue to $11.4 million and securing CMS New Technology Add-On Payment status.

Abeona Therapeutics shareholders elected directors, ratified auditors, and approved an equity plan increase at the 2026 annual meeting.

Abeona Therapeutics Inc. announced the immediate resignation of board member Michael Amoroso for personal reasons.

Abeona Therapeutics has released an updated investor presentation for use in upcoming stakeholder engagements.

Abeona Therapeutics Inc. reports a constructive Pre-IND meeting with the FDA regarding its novel T-cell therapy ABO-701 for prostate cancer, targeting IND submission in 2027.

Abeona Therapeutics reported Q1 2026 results with $8.7M in net product revenue, expanded ZEVASKYN adoption, and in-licensed a novel T-cell therapy for solid tumors.

Abeona Therapeutics expands its board to ten members, appointing industry veteran Keith A. Goldan as Audit Committee Chair to support its commercial-stage growth.

Abeona Therapeutics reported a significant turnaround in 2025, achieving net income of $71.2 million driven by the sale of a Priority Review Voucher and initial ZEVASKYN commercialization.

Abeona Therapeutics reported improved Q3 2025 financial results and strong ZEVASKYN demand, despite a one-quarter delay in patient treatment starts due to assay optimization.

Abeona Therapeutics reported robust second-quarter 2025 financial results, driven by the sale of a priority review voucher, and confirmed the successful initial launch and positive payer coverage for its newly FDA-approved gene therapy, ZEVASKYN.

Abeona Therapeutics Inc. has amended its Loan and Security Agreement, reducing its senior secured term loan interest rate to 11.75% while issuing warrants for up to 16,474 common shares to its lenders.

Abeona Therapeutics Inc. announced the successful completion of its Rare Pediatric Disease Priority Review Voucher sale for $155 million, significantly enhancing its cash position to approximately $225 million and providing over two years of operating capital.

Abeona Therapeutics held its annual stockholders meeting on May 19, 2025, and elected directors, approved executive compensation, and ratified the appointment of Deloitte & Touche LLP as its independent accounting firm.

Abeona Therapeutics announces FDA approval for ZEVASKYN, a gene therapy for RDEB, and reports its first quarter 2025 financial results, highlighting a net loss reduction and progress towards commercialization.

Abeona Therapeutics has entered into an agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for $155 million.

Abeona Therapeutics Inc. will host a conference call and webcast on April 29, 2025, to discuss company updates, with accompanying slides and patient videos.

Abeona Therapeutics announces FDA approval for ZEVASKYN (prademagene zamikeracel), the first and only cell-based gene therapy for recessive dystrophic epidermolysis bullosa (RDEB).

Abeona Therapeutics announced its full year 2024 financial results, progress in the FDA review of pz-cel, and commercial launch plans, targeting the first patient treatment in 3Q 2025 if approved.

Abeona Therapeutics' stockholders approved an increase in the number of shares reserved for issuance under the company's equity incentive plan at a special meeting on December 20, 2024.

Abeona Therapeutics reports positive progress with its pz-cel BLA resubmission accepted by the FDA, setting a PDUFA target action date of April 29, 2025, and significant steps towards commercialization.

Abeona Therapeutics has announced the FDA's acceptance of their Biologics License Application (BLA) resubmission for pz-cel, a potential gene therapy for recessive dystrophic epidermolysis bullosa (RDEB), with a target action date set for April 29, 2025.

Abeona Therapeutics has resubmitted its Biologics License Application (BLA) to the FDA for pz-cel, a gene therapy for recessive dystrophic epidermolysis bullosa (RDEB).

Abeona Therapeutics has appointed Bernhardt G. Zeiher and Eric Crombez as independent directors to its Board, bringing extensive drug development and clinical expertise.

Abeona Therapeutics announced its second quarter 2024 financial results, highlighted by progress on its pz-cel BLA resubmission and a $75 million capital raise.

Abeona Therapeutics has amended its bylaws to allow for special board meetings with only 24 hours' notice, facilitating quicker decision-making.

Abeona Therapeutics announced its first quarter 2024 financial results, highlighted by a $75 million capital raise and plans to resubmit its Biologics License Application (BLA) for pz-cel in the second half of 2024.

Abeona Therapeutics has announced the pricing of a $75 million underwritten offering of common stock and pre-funded warrants.

Abeona Therapeutics announced preliminary cash holdings of $62.7 million as of March 31, 2024, and the suspension of its at-the-market (ATM) share sales program.

Abeona Therapeutics' stockholders approved an increase in shares reserved for issuance under the 2023 Equity Incentive Plan and elected two directors at their annual meeting on April 24, 2024.

Abeona Therapeutics received a Complete Response Letter from the FDA for its pz-cel Biologics License Application, requiring additional Chemistry, Manufacturing, and Controls information, but not raising concerns about clinical efficacy or safety.