Regeneron plans for quick redecision on CRL for higher dose of Eylea

Re­gen­eron saw its stock price rise by more than 6% on Thurs­day af­ter an­nounc­ing a faster than ex­pect­ed de­ci­sion on its soon-to-be re­sub­mit­ted ap­pli­ca­tion for a high­er dosage ver­sion of its block­buster Eylea (afliber­cept).

Lat­er this quar­ter Re­gen­eron said it would hear back from FDA with a re­sponse to de­fi­cien­cies in man­u­fac­tur­ing that were un­cov­ered at its con­tract man­u­fac­tur­er Catal­ent.

An an­a­lyst re­port from Leerink Part­ners on Thurs­day not­ed that the an­nounced tim­ing is “faster than many ex­pect­ed” as a six month res­bu­mis­sion time­line was spec­u­lat­ed when the CRL was hand­ed down in June. How­ev­er, Leerink not­ed that if the FDA find the in­for­ma­tion from Catal­ent isn’t enough to solve the is­sues, the FDA may re­quire more da­ta, qual­i­ty stud­ies, rein­spec­tions or oth­er in­for­ma­tion, drag­ging out the time­line fur­ther.

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