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Celgene Plots Blockbuster Course For Ozanimod

Executive Summary

Celgene, in need of good news, posted positive data on a potential blockbuster for multiple sclerosis at the joint ECTRIMS-ACTRIMS meeting. Ozanimod could have important safety and tolerability advantages over Gilenya, but investors already were expecting good news.

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Keeping Track: Delay (For Celgene), Delay (For Allergan), Goose! (Approval For Lilly)

The latest drug development news and highlights from our US FDA Performance Tracker.

Celgene Joins Troubled MS Club With Refuse To File For Ozanimod From US FDA

Other multiple sclerosis contenders – including Sanofi's Lemtrada, Acorda's Ampyra, and Merck KgAA's cladribine – have also been RTFed. Question now for Celgene is how long the delay will be. 

More Bad News: Celgene Reveals Refuse-To-File Letter For Ozanimod In MS

Celgene said the US FDA issued a refuse-to-file letter for ozanimod in multiple sclerosis because "the nonclinical and clinical pharmacology sections in the NDA were insufficient to permit a review." It's yet another big blow for a company whose value has been falling since October.

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