ABEO Stock Recent News

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

Significant progress addressing CMC items noted in CRL BLA resubmission remains on track for 2H 2024 CLEVELAND, Aug. 12, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today reported financial results for the second quarter of 2024 and recent corporate progress. “Having completed data generation for nearly all of the Chemistry Manufacturing and Controls deliverables outlined in the Complete Response Letter that we received in April 2024, we are on track to resubmit our Biologics License Application for pz-cel this year and, if approved, bring a treatment option to patients with recessive dystrophic epidermolysis bullosa,” said Vish Seshadri, Chief Executive Officer of Abeona.

CLEVELAND, Aug. 01, 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).

Abeona Therapeutics Inc.'s BLA resubmission of Pz-cel for the treatment of patients with recessive dystrophic epidermolysis bullosa is expected 2nd half of 2024. If Pz-cel is approved by the FDA, the company believes that it could reach peak U.S. sales of >$500 million by year 5 of the gene therapy being sold. FDA approval of Pz-cel for RDEB would allow Abeona to obtain a Priority Review Voucher, which it could keep or sell to another company for a considerable amount of cash.

CLEVELAND and LONDON, July 11, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a cell and gene therapy company with proprietary adeno-associated virus (AAV)-based capsids, and Beacon Therapeutics, an ophthalmic gene therapy company and Syncona portfolio company, today announced an agreement by which Beacon will evaluate Abeona's patented AAV204 capsid for the development and commercialization of potential gene therapies for select ophthalmology indications.

CLEVELAND, July 08, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that Abeona's Chief Executive Officer, Vish Seshadri, Ph.D., M.B.A., and Chief Commercial Officer, Madhav Vasanthavada, Ph.D., M.B.A., will participate in a virtual fireside chat at the Stifel Virtual Cell Therapy Forum on Tuesday, July 9, 2024 at 9:45 a.m. Eastern Time.

NEW YORK, NY / ACCESSWIRE / June 9, 2024 / Pomerantz LLP is investigating claims on behalf of investors of Abeona Therapeutics Inc. ("Abeona" or the "Company") (NASDAQ:ABEO). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext.