viernes, 7 de junio de 2019

Celgene wins approval to possibly win approval

The Readout
Damian Garde

Celgene wins approval to possibly win approval

Yesterday, the FDA accepted Celgene's application related to a drug for multiple sclerosis. That doesn't guarantee the treatment, called ozanimod, will actually get approved, and it's not the sort of news anyone pays much attention to for a company that size. But considering the year Celgene's had, it's a fairly mountainous regulatory molehill.

Here's why: About a year ago, the FDA refused to even consider the ozanimod application, a rare and embarrassing occurrence for a large drug company, not to mention a frightening development for its shareholders.

In the time since, Bristol-Myers Squibb agreed to trade every outstanding share of Celgene for one share of Bristol, $50 in cash, and one lottery ticket called a CVR. That lottery ticket could transform into $9 of cash if three of Celgene's pipeline drugs wins approval on a specific timeline, but if even one drops out, the CVR is worthless. Thanks to the FDA, ozanimod could now win approval in early 2020, which would mark the first milestone on Celgene's path to rewarding anyone who held onto shares during the dark days of 2018.

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