- Celgene said Tuesday that the FDA refused to review its multiple sclerosis drug Ozanimod for approval.
- “Upon its preliminary review, the FDA determined that the nonclinical and clinical pharmacology sections in the NDA were insufficient to permit a complete review,” Celgene said in a news release. NDA is short for new drug application.
- Ozanimod, if approved, is expected to make as much as $US2 billion in peak sales.
- Celgene has had a difficult couple of months. In October 2017, the company had a huge earnings flop. The company’s also made two acquisition deals in 2018 so far, but the news hasn’t been enough to excite investors.
- Celgene’s stock fell as much as 6% in pre-market trading on Wednesday.
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