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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