Celgene gets refusal to file letter for ozanimod

Celgene Corp. (NASDAQ:CELG) said FDA issued a refusal to file letter for an NDA for multiple sclerosis therapy ozanimod, which could be a key near-term revenue driver for the bellwether. The company, which announced the news after market close Tuesday, was off $5.98 to $89.80 in early after-hours trading.

On a conference call, Chairman and CEO Mark Alles said the company is reevaluating the timing of worldwide regulatory submissions, which include an MAA to EMA. In January, the company said it had expected to submit an MAA this quarter. ...