Is second time the charm for ozanimod? Celgene starts to find out with EMA filing
Celgene has officially embarked on ozanimod’s comeback regulatory journey, submitting an application to the EMA days before it plans to knock on the FDA’s door — just in time for the deadline it has set for itself.
Saying Celgene — and Bristol-Myers, which is set to acquire the biotech as long as the growing investor opposition doesn’t derail the deal — has a lot riding on the decision would be an understatement. Following an embarrassing refuse-to-file episode with the FDA last February, positive progress here is crucial not just to materialize ozanimod’s blockbuster promises as a cash cow as Revlimid approaches a patent cliff, but to prove Celgene’s team still possesses the development shrewdness that marked the company for years.
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