FDA further delays Abeona's BLA for EB-101

Shares of US gene and cell therapy company Abeona Therapeutics (Nasdaq: ABEO) closed down 6.5% at $4.01 on Friday, when it announced receipt of feedback from the US Food and Drug Administration (FDA) regarding EB-101 for the treatment of patients with recessive dystrophic epidermolysis bullosa (RDEB).

Abeona noted that it 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 of Abeona.