BOUNCE

[cintrix]

ABEO down 47% The CRL from the FDA notes that the regulator needs additional Chemistry Manufacturing and Controls (CMC) information from Abeona Therapeutics. As such, the agency refused to approve Pz-cel.

Abeona Therapeutics intends to provide the FDA with this information but can’t do so in a manner that is timely for the agency. This also prevents the Biologics License Application to treat patients with recessive dystrophic epidermolysis bullosa.