FDA hands CRL to Abeon­a's rare skin dis­ease cell ther­a­py

Abeona Ther­a­peu­tics’ shares dropped by al­most 50% pre-mar­ket Tues­day af­ter re­ceiv­ing an FDA com­plete re­sponse let­ter for its cell ther­a­py for epi­der­mol­y­sis bul­losa. The as­set’s PDU­FA date is al­so de­layed from the orig­i­nal May 25 date.

Af­ter a meet­ing with Abeona in March, the FDA not­ed more in­for­ma­tion on chem­istry, man­u­fac­tur­ing and con­trol was need­ed be­fore its lead can­di­date, dubbed pradema­gene za­mik­er­a­cel (pz-cel), can be ap­proved in the rare skin con­di­tion. The FDA re­quest­ed fur­ther da­ta on man­u­fac­tur­ing and re­lease test­ing meth­ods, in­clud­ing ob­ser­va­tions found dur­ing the agency’s pre-li­cense in­spec­tion.

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