By Chris Wack

Abeona Therapeutics said Friday that it received feedback from the U.S. Food and Drug Administration, in which it gained the FDA's alignment on the data required to establish retroviral vector comparability, a critical chemistry, manufacturing and controls component for the EB-101 Biologics License Application.

As part of the package, the FDA requested additional assay data to establish comparability between retroviral vector sourced from Indiana University and retroviral vector manufactured in-house at Abeona, both of which have been used in the EB-101 clinical studies.

The company said it has the necessary reagents in-house to promptly generate the requested data. To allow the FDA the necessary time to review the requested retroviral vector data, Abeona has requested that its pre-BLA meeting date for EB-101 be rescheduled for August.

The Company expects to file its BLA for EB-101 in the third quarter of 2023.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

June 09, 2023 07:53 ET (11:53 GMT)

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