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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).
Abeona Therapeutics Inc.'s lead program, pz-cel, is an autologous gene therapy for RDEB, showing significant wound healing and pain reduction in clinical trials. Despite a CRL from the FDA, Abeona resubmitted its BLA, with a new PDUFA date set for April 29, 2025. ABEO stock remains undervalued, with potential for significant gains if pz-cel is approved, supported by strong cash reserves and a valuable PRV.
Abeona Therapeutics' Pz-cel, a gene-corrected cell therapy for RDEB, is expected to resubmit its BLA in 2H2024, targeting FDA approval by mid-2025. ABEO's AIM platform uses AAV vectors for targeted genetic material delivery, with a pipeline including therapies for genetic eye conditions and neurological diseases. Pz-cel offers long-lasting treatment for RDEB, addressing a substantial total addressable market.
CLEVELAND, Sept. 02, 2024 (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, Aug. 14, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced the appointment of Bernhardt G. Zeiher, MD, FCCP, FACP, and Eric Crombez, MD as new independent members to its Board of Directors. Dr. Zeiher brings more than 20 years of drug development experience where, in various roles, he oversaw the approval of 15 new treatments that addressed unmet needs in serious diseases with few to no treatment options. Dr. Crombez currently serves as Chief Medical Officer of Ultragenyx Pharmaceutical Inc. and brings extensive expertise in the development and execution of clinical development programs for rare genetic disorders.
CMS grants ICD-10-PCS product-specific procedure code and favorable DRG assignment for pz-cel, supporting efficient hospital billing, reimbursement and patient access CMS grants ICD-10-PCS product-specific procedure code and favorable DRG assignment for pz-cel, supporting efficient hospital billing, reimbursement and patient access