Abeona’s new Form 483 is another manufacturing setback for its rare skin condition asset

Abeona Ther­a­peu­tics was hand­ed a Form 483 “re­lat­ed to process con­trols” for its epi­der­mol­y­sis bul­losa can­di­date in a sec­ond man­u­fac­tur­ing-re­lat­ed road­block for the pro­gram, with the biotech’s stock drop­ping by as much as 16% on Mon­day.

The biotech sub­mit­ted a re­sponse to the doc­u­ment on Fri­day, which not­ed con­cerns at the com­pa­ny’s man­u­fac­tur­ing site in Cleve­land, ac­cord­ing to a full-year earn­ings re­lease. The doc­u­ment was is­sued af­ter a two-week pre-li­cense in­spec­tion, which con­clud­ed on March 1.

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