Welcome to our dedicated page for Abeona Therapeut news (Ticker: ABEO), a resource for investors and traders seeking the latest updates and insights on Abeona Therapeut stock.
Abeona Therapeutics Inc (NASDAQ: ABEO) is a clinical-stage biopharmaceutical leader advancing gene therapies for rare genetic diseases. This dedicated news hub provides investors and researchers with essential updates on ABEO’s therapeutic developments, regulatory milestones, and scientific partnerships.
Discover timely press releases detailing progress in AAV-based therapies, CRISPR/Cas9 research, and pivotal clinical trials for conditions like epidermolysis bullosa. Our curated collection includes FDA correspondence updates, manufacturing quality certifications, and strategic collaboration announcements – all critical for evaluating the company’s trajectory.
Key content categories feature BLA submission statuses, Phase 3 trial results, and technology licensing agreements. Bookmark this page for streamlined access to verified updates about ABEO’s pipeline candidates and operational developments, presented with clarity for both professional analysts and engaged stakeholders.
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.
Abeona Therapeutics (Nasdaq: ABEO) announced the granting of equity awards to ten new non-executive employees as inducement for their employment. The awards, approved under Nasdaq Listing Rule 5635(c)(4), consist of 19,420 restricted shares of Abeona common stock in aggregate.
The shares will vest in three equal annual installments, with full vesting occurring on the third anniversary of the Grant Date, contingent on continued employment. The grants were approved by Abeona's Board of Directors Compensation Committee on September 30, 2025.
Abeona Therapeutics (Nasdaq: ABEO) announced the granting of equity awards to seven new non-executive employees. The awards, approved under Nasdaq Listing Rule 5635(c)(4), consist of 15,500 restricted shares of Abeona common stock in aggregate.
The restricted stock awards will vest in three equal annual installments, with full vesting occurring on the third anniversary of the August 31, 2025 grant date, contingent upon continued employment with the company.
Abeona Therapeutics (Nasdaq: ABEO) has announced its participation in two major investor conferences in September 2025. The company will participate in a fireside chat at the Cantor Global Healthcare Conference on September 4, 2025 at 10:20 a.m. ET, and deliver a company presentation at the H.C. Wainwright 27th Annual Global Investment Conference on September 9, 2025 at 2:00 p.m. ET.
Both events will include investor meetings and will be webcast live on the company's investor relations website, with replays available for a limited time.
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