ABEO Stock Recent News

The U.S. Food and Drug Administration on Tuesday approved Abeona Therapeutics' gene therapy for a rare skin disorder.

- ZEVASKYN fills a critical need for people living with RDEB, a debilitating dermatological condition with no cure - - Approval based on the pivotal Phase 3 VIITAL™ study, showing ZEVASKYN resulted in significant wound healing and pain reduction after a single treatment with a favorable safety profile - - ZEVASKYN to be available through Qualified Treatment Centers beginning in 3Q 2025 - - Abeona Assist™ patient services program offers personalized support for eligible patients and families throughout their treatment journey with ZEVASKYN - - Rare Pediatric Disease Priority Review Voucher (PRV) granted by FDA - - Abeona Therapeutics ® to host conference call today, Tuesday, April 29, 2025, at 8:00 a.m. ET - CLEVELAND, April 29, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced the U.S. Food and Drug Administration (FDA) has approved ZEVASKYN™ (pronounced as ‘ZEE-vah-skin') (prademagene zamikeracel) gene-modified cellular sheets, also known as pz-

Abeona's pz-cel gene therapy shows the most durable wound healing in RDEB patients with no treatment related severe adverse events. There have been no instances of Squamous Cell Carcinoma. The FDA's previous Complete Response Letter focused on manufacturing and control issues. Since those questions have been answered thoroughly, an approval is likely by April 29th. Pz-cel offers a durable, one-time treatment. This reduces long-term costs compared to VYJUVEK which requires ongoing weekly applications.

Abeona Therapeutics is poised for significant growth in 2025, with potential FDA approvals for Pz-cel and UX111, driving our Buy rating. Pz-cel, targeting RDEB, shows promising clinical data and commercial prospects, with an expected FDA decision by April 29, 2025. UX111, aimed at MPS IIIA, also holds strong potential, with an FDA decision anticipated by August 18, 2025, and substantial market opportunities.

CLEVELAND, April 01, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced it has granted equity awards to new non-executive employees who joined the Company. The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4).

Abeona Therapeutics Inc. (NASDAQ:ABEO ) Q4 2024 Earnings Conference Call March 20, 2025 8:30 AM ET Company Participants Greg Gin – Vice President-Investor Relations and Communications Vish Seshadri – Chief Executive Officer Madhav Vasanthavada – Chief Commercial Officer and Head-Business Development Brian Kevany – Chief Technical Officer Joe Vazzano – Chief Financial Officer Conference Call Participants Kristen Kluska – Cantor François Brisebois – Oppenheimer Ram Selvaraju – H.C. Wainwright David Bautz – Zacks Small Cap Research Operator Greetings.

FDA priority review of pz-cel Biologics License Application (BLA) progressing with Prescription Drug User Fee Act (PDUFA) target action date of April 29, 2025

CLEVELAND, March 04, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that Abeona's Chief Executive Officer, Vish Seshadri, Ph.D., M.B.A., will present at the Leerink Partners Global Healthcare Conference in Miami, Florida on Monday, March 10, 2025 at 3:00 p.m.

CLEVELAND, March 03, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced it has granted equity awards to new non-executive employees who joined the Company. The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4).

CLEVELAND, Feb. 03, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced it has granted equity awards to new non-executive employees who joined the Company. The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4).