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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