Abeona leaps, as FDA accepts its pz-cel BLA for priority review

The US Food and Drug Administration (FDA) has accepted and granted priority review for the Biologics License Application (BLA) for prademagene zamikeracel (pz-cel), submitted by Abeona Therapeutics (Nasdaq: ABEO), whose shares touched a five-month high of $5.05, and were still up 11.6% at $4.81 by close of trading yesterday.

Pz-cel is Abeona’s investigational autologous, COL7A1 gene-corrected epidermal sheets for the treatment of patients with recessive dystrophic epidermolysis bullosa (RDEB).

This was welcome news for the development of pz-cel, formally known as EB-101, which had a setback earlier this year, when 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.