Celgene Plots Blockbuster Course For Ozanimod
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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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.
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.