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Abeona Therapeutics Announces Regulatory Update on Biologics License Application (BLA) for EB-101
CLEVELAND, June 09, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that it received feedback from the U.S. Food and Drug
About this update from Abeona Therapeutics Inc.
[{"type":"text","content":"CLEVELAND, June 09, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that it received feedback from the U.S. Food and Drug Administration (FDA) on June 8, 2023, in which the Company gained the Agency’s alignment on the data required to establish retroviral vector (RVV) comparability, a critical Chemistry, Manufacturing and Controls (CMC) component for the EB-101 Biologics License Application (BLA). “Gaining alignment with the FDA on the RVV comparability package is a very important de-risking milestone for our BLA submission after our recent successful completion of the Process Performance Qualification (PPQ) manufacturing validation runs,” said Vish Seshadri, Chief Executive Officer of Abeona. As part of the package, the FDA requested additional assay data to establish comparability between RVV sourced from Indiana University and RVV manufactured in-house at Abeona, both of which have been used in the EB-101 clinical studies. The Company has the necessary reagents in-house to promptly generate the requested data. To allow the FDA the necessary time to review the requested RVV data, Abeona has requested that its pre-BLA meeting date for EB-101 be rescheduled for August 2023. The Company expects to file its BLA for EB-101 in the third quarter of 2023. About Abeona Therapeutics Abeona Therapeutics Inc. is a clinical-stage biopharmaceutical company developing cell and gene therapies for serious diseases. Abeona’s lead clinical program is EB-101, its investigational autologous, engineered cell therapy currently in development for recessive dystrophic epidermolysis bullosa. The Company’s development portfolio also features AAV-based gene therapies for ophthalmic diseases with high unmet medical need. Abeona’s novel, next-generation AAV capsids are being evaluated to improve tropism profiles for a variety of devastating diseases. Abeona’s fully integrated cell and gene therapy cGMP manufacturing facility produces EB-101 for the pivotal Phase 3 VIITAL™ study and is capable of clinical and potential commercial production of AAV-based gene therapies. For more information, visit www.abeonatherapeutics.com. Forward-Looking Statements This press release contains certain statements that are forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Secur...