Anavex Life Sciences Corp (AVXL): https://seekingalpha.com/news/3334878-ce...

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Tuesday, 02/27/2018 5:27:41 PM

Tuesday, February 27, 2018 5:27:41 PM

https://seekingalpha.com/news/3334878-celgene-minus-8-percent-fda-turns-away-multiple-sclerosis-drug-application

Celgene -8% after FDA turns away multiple sclerosis drug application
Feb. 27, 2018 5:19 PM ET|About: Celgene Corporation (CELG)|By: Carl Surran, SA News Editor
Celgene (NASDAQ:CELG) -7.8% after-hours on news the U.S. Food and Drug Administration rejected its new drug application for a multiple sclerosis treatment, a surprise that likely will delay the entry of one of its most important pipeline assets.

CELG says it received a "refusal to file" letter from the FDA for the company's drug ozanimod for the treatment of patients with relapsing multiple sclerosis because of insufficient data.

CELG says it will "seek immediate guidance, including requesting a Type A meeting with the FDA, to ascertain what additional information will be required to resubmit the NDA."