FDA puts the brakes on a rare disease biotech’s PhIII as regulators wait for an update — shares crumble
Little Abeona Therapeutics $ABEO is back in trouble this morning.
The biotech reported that the FDA is slamming the brakes on their Phase III study of EB-101 for rare cases of recessive dystrophic epidermolysis bullosa, which is characterized by fragile skin that blisters quickly.
The drug uses gene transfer to deliver COL7A1 genes into a patient’s own skin cells, which are then put back into the patient’s skin for improved wound healing. It has RMAT and breakthrough status at the FDA but doesn’t have approval for the Phase III.
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