Highest-materiality recent filing
Abeona shareholders reject removing advance notice provision; approve share reserve increase
Directors Goldan and Zeiher elected; say-on-pay and Deloitte auditor ratified.
Abeona Therapeutics director Michael Amoroso resigns from board for personal reasons
Michael Amoroso resigned from Abeona's Board effective June 11, 2026.
Abeona furnishes updated investor presentation; no details available
Company filed an 8-K to furnish an updated investor presentation dated June 10, 2026.
Abeona holds constructive Pre-IND meeting with FDA for ABO-701; IND target 2027
Pre-IND meeting with FDA held June 3, 2026 for ABO-701, a T-cell therapy targeting PSMA for prostate cancer.
Net product revenue of $8.7M from ZEVASKYN, up from $2.4M in Q4 2025; net loss $17.1M ($0.30/sh).
Abeona Therapeutics appoints Keith Goldan as new independent Board member and Audit Committee Chair
Board expanded from 9 to 10 members; Goldan appointed as Class 1 director effective April 1, 2026.
Stockholder meeting quorum increased from one-third to 50% of shares entitled to vote.
Abeona reports $71.2M net income in FY 2025; first ZEVASKYN patient treated
First ZEVASKYN commercial patient treated in Dec 2025; net product revenue $2.4M; one patient treated in Q1 2026 with more biopsies collected.
Abeona reports building ZEVASKYN launch momentum; payer coverage reaches 80% of commercial lives
First patient treated with ZEVASKYN in Dec 2025; manufacturing resumed Jan 2026, multiple biopsies collected, additional scheduled.
Abeona Q3 net loss narrows to $5.2M; ZEVASKYN first treatment delayed to Q4 2025
Net loss of $5.2M ($0.10/sh) vs $30.3M ($0.63/sh) in Q3 2024; R&D expense fell to $4.2M, SG&A rose to $19.3M on commercial launch.
Abeona reports Q2 net income of $108.8M on PRV sale; ZEVASKYN launch on track
Net income $108.8M ($2.07 basic EPS) vs $7.4M in Q2 2024; includes $155M gain from PRV sale.
Abeona amends loan with Avenue, cuts interest rate to 11.75% and issues warrants for 16,474 shares
Interest rate on senior secured term loan reduced from 13.5% to 11.75% fixed per annum.
Abeona closes sale of Rare Pediatric Disease PRV for $155M; cash at $225M
Closed sale of Rare Pediatric Disease Priority Review Voucher for $155M gross proceeds on June 27, 2025.
Abeona Therapeutics holds annual meeting; elects three Class 3 directors
Mark J. Alvino, Faith L. Charles, and Donald A. Wuchterl elected as Class 3 directors.
Abeona Q1 net loss $12M; ZEVASKYN approved Apr 28, PRV sold for $155M
Net loss of $12.0M ($0.24/share) vs. $31.6M ($1.16/share) in Q1 2024; no revenue yet.
Abeona Therapeutics sells PRV for $155M cash; expects profitability early 2026
Definitive agreement to sell Rare Pediatric Disease PRV for $155M in gross cash proceeds at closing.
FDA approves Abeona's ZEVASKYN, first cell-based gene therapy for RDEB
81% of ZEVASKYN-treated wounds achieved ≥50% healing at 6 months vs 16% control (P<0.0001) in Phase 3 VIITAL study.
Abeona Therapeutics files 8-K with webcast presentation; no material financial data disclosed
Webcast presentation furnished as Exhibit 99.1; content not provided in this filing text.
Abeona Therapeutics reports FY2024 net loss $63.7M, cash $98.1M, pz-cel PDUFA April 29
Net loss of $63.7M ($1.55 per share) for FY2024 vs $54.2M ($2.53 per share) in FY2023.
Stockholders approve Abeona equity plan share increase from 3.2M to 8.4M
Special meeting on Dec 20, 2024: 56.35% quorum with 24,567,979 shares represented.
Abeona Q3 net loss $30.3M; FDA sets pz-cel PDUFA Apr 29, 2025
Net loss Q3 2024: $30.3M vs $11.8M YoY; includes $15.2M warrant revaluation loss.
Abeona Therapeutics: FDA accepts BLA resubmission for pz-cel; PDUFA date April 29, 2025
FDA accepted for review Abeona's resubmitted BLA for pz-cel (autologous cell-based gene therapy for recessive dystrophic epidermolysis bullosa).
Abeona Therapeutics resubmits BLA for pz-cel gene therapy for RDEB to FDA
Resubmitted Biologics License Application (BLA) for pz-cel to FDA for recessive dystrophic epidermolysis bullosa (RDEB).
Abeona Therapeutics appoints Drs. Zeiher and Crombez to Board of Directors
Bernhardt G. Zeiher, MD appointed as Class 1 director; Eric Crombez, MD as Class 2 director; both independent.
Abeona reports Q2 net income of $7.4M; FDA aligned on pz-cel BLA resubmission for 2H 2024
Net income of $7.4M in Q2 2024 (includes $24.9M gain on warrant liabilities) vs net loss of $16.7M in Q2 2023.
Board approved amendment and restatement of bylaws on July 5, 2024, effective July 8, 2024.
Abeona Q1 net loss $31.6M; BLA resubmission expected H2 2024; closed $75M offering
Net loss $31.6M ($1.16/share) vs. $9.1M loss a year ago; cash $62.7M at March 31, up from $52.6M.
Abeona reports preliminary Q1 cash $62.7M; terminates $106M ATM prospectus
Preliminary cash, equivalents, and investments of $62.7M as of March 31, 2024.
Abeona Therapeutics prices $75M underwritten offering of common stock and pre-funded warrants
Offering: 12,285,056 common shares at $4.07/share and 6,142,656 pre-funded warrants at $4.0699 each.
Abeona shareholders approve equity plan increase to 3.2M shares; re-elect two directors
A&R 2023 Equity Incentive Plan approved, increasing shares reserved from 1.7M to 3.2M (1.5M new shares).
Abeona receives FDA Complete Response Letter for pz-cel BLA due to CMC deficiencies
FDA CRL for pz-cel BLA cites additional CMC information needed; no clinical efficacy/safety deficiencies.
FDA completed Pre-License Inspection of Cleveland manufacturing facility; Form 483 issued for process controls; company submitted response.
Abeona secures $50M credit facility; $20M funded at close for pz-cel launch prep
$50M term loan from Avenue Venture Opportunities; $20M drawn at Jan 8 close, $10M committed after pz-cel approval, $20M discretionary.
FDA accepts and grants Priority Review for Abeona's pz-cel BLA; PDUFA date May 25, 2024
FDA accepted BLA for pz-cel (prademagene zamikeracel) for recessive dystrophic epidermolysis bullosa (RDEB) with Priority Review.
Abeona submits BLA for pz-cel; Q3 net loss $11.8M, cash $54.1M
Q3 net loss $11.8M ($0.48/share) vs $6.4M ($1.00/share) in Q3 2022.
Abeona Therapeutics dismisses Whitley Penn, appoints Deloitte as auditor effective Oct 17, 2023
Deloitte & Touche LLP engaged as independent registered public accounting firm for FY 2023.
Abeona Therapeutics Q2 net loss $16.7M; on track for EB-101 BLA submission in Q3 2023
Net loss $16.7M ($0.92/share) vs $7.9M ($1.36/share) in Q2 2022; revenue $3.5M from license.
Abeona closes $25M direct offering; proceeds to fund EB-101 commercialization
Gross proceeds of $25M from sale of 3.28M shares and 2.92M pre-funded warrants at $4.03 per share.
Abeona raises $25M in registered direct offering at $4.03/share to fund EB-101 launch prep
Gross proceeds ~$25M; net ~$22.9M after fees and expenses.
Abeona shareholders elect directors, approve 2023 equity plan at annual meeting
Michael Amoroso (6.5M for) and Christine Silverstein (6.2M for) elected Class I directors until 2026.
Abeona Therapeutics Q1 net loss $9.1M; cash runway into Q3 2024; advancing EB-101 BLA submission
Net loss of $9.1M ($0.54 loss per share) vs $22.0M ($3.80) in Q1 2022; license revenue nil.
Abeona Therapeutics reduces board size to seven; Chairman moves director class for compliance
Board size decreased from nine to seven directors, effective at 2023 Annual Shareholder Meeting.
Abeona Therapeutics FY2022 net loss narrows to $43.5M; EB-101 BLA submission on track
Net loss $43.5M ($5.53/share) vs $84.9M ($21.57/share) in FY2021 as expense reductions offset lower revenue.
Abeona confirms no cash or securities at Silicon Valley Bank
Company holds no cash deposits or securities at Silicon Valley Bank.
Abeona Q3 net loss $9.5M; Phase 3 EB-101 meets endpoints, BLA submission planned Q2 2023
Net loss of $9.5M ($1.48 loss per share) for Q3 2022, compared to $7.0M loss in Q3 2021.
Abeona Phase 3 VIITAL study of EB-101 meets co-primary endpoints; BLA submission planned Q2 2023
81.4% of treated wounds achieved ≥50% healing vs 16.3% controls (p<0.0001).
Abeona raises $35M in private placement; Phase 3 EB-101 trial meets endpoints
Gross proceeds of $35M from sale of 7.07M shares, pre-funded warrants for 0.54M shares, and common warrants for 7.61M shares.
Abeona shareholders elect three Class 3 directors, approve equity plan amendment
Three Class 3 directors elected: Alvino (1.25M for), Charles (1.34M for), Wuchterl (1.35M for).
Abeona Q2 net loss $12.1M; cash runway to 2Q 2023; VIITAL data expected late Q3/early Q4
Net loss $12.1M ($2.08 loss/share) vs $15.2M ($3.93 loss/share) in Q2 2021.
Abeona regains Nasdaq compliance with minimum bid price requirement
Received Nasdaq notification on July 19, 2022 confirming compliance with Listing Rule 5550(a)(2).
On June 11, 2026, Michael Amoroso resigned as a member of the Board of Directors (the “Board”) of Abeona Therapeutics Inc. (the “Company”) effective immediately.
appointed Bernhardt G. Zeiher, MD, FCCP, FACP, on August 8, 2024 and Eric Crombez, MD on August 12, 2024 as members of the Board of the Company.
appointed Bernhardt G. Zeiher, MD, FCCP, FACP, on August 8, 2024 and Eric Crombez, MD on August 12, 2024 as members of the Board of the Company.
On March 3, 2022, Edward Carr, Chief Financial Officer and Chief Accounting Officer of Abeona Therapeutics Inc. (the “Company”), notified the Company of his resignation effective March 31, 2022.
Also on March 3, 2022, the Board appointed Joseph Vazzano as Chief Financial Officer effective March 14, 2022.
Steven Rouhandeh, Chairman of the Board, notified the Company of his retirement and resignation as a member of the Board effective October 14.
the Board appointed Vishwas Seshadri, Ph.D., M.B.A., as President and Chief Executive Officer and director effective October 15, 2021.
Michael Amoroso, President and Chief Executive Officer of Abeona Therapeutics Inc. (the “Company”), and a member of the Board of Directors (the “Board”), notified the Company of his resignation as President and Chief Executive Officer effective October 14, 2021.
the Board voted unanimously to appoint Mr. Amoroso Chairman of the Board effective October 15.
appointed Edward Carr, the Company’s Chief Accounting Officer, as Senior Vice President, Chief Financial Officer, effective on that same date.
Max materiality 0.95 · Median 0.65 · Most common event other_material