FDA lifts hold on Abeon­a's but­ter­fly dis­ease ther­a­py, paving way for piv­otal study

It’s been a dif­fi­cult few years for gene and cell ther­a­py start­up Abeona Ther­a­peu­tics. Its new­ly crowned chief Carsten Thiel was forced out last year fol­low­ing ac­cu­sa­tions of un­spec­i­fied “per­son­al mis­con­duct,” and this Sep­tem­ber, the FDA im­posed a clin­i­cal hold on its ther­a­py for a form of “but­ter­fly” dis­ease. But things are be­gin­ning to perk up. On Mon­day, the com­pa­ny said the reg­u­la­tor had lift­ed its hold and the ex­per­i­men­tal ther­a­py is now set to be eval­u­at­ed in a late-stage study.

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