FDA Target Action Date Arrives For Bristol-Myers’ Ozanimod

Amid the uncertainty and upheaval caused by the coronavirus pandemic, Bristol-Myers Squibb Co. Wednesday struck an optimistic tone regarding the status of its pending drug applications as a key U.S. regulatory date arrives.
The U.S. Food and Drug Administration previously set Wednesday as its target action date for a decision on ozanimod for the treatment of relapsing forms of multiple sclerosis.
In a filing with the Securities and Exchange Commission, Bristol-Myers said it continue to engage with regulatory authorities around the world and that it has been “encouraged by their continued commitment in ongoing regulatory processes.”
Ozanimod is one of three drugs tied to the contingent value rights that Bristol-Myers issued in its $74 billion acquisition of Celgene, which it completed in November.
Meanwhile, the FDA has a target action date of April 4 for a decision on the use of the anemia drug Reblozyl in patients with myelodysplastic syndromes. Celgene and Acceleron Pharma Inc. are co-developing Reblozyl under a collaboration they formed in 2011.
The applications for ozanimod and Reblozyl are also currently under review in Europe, and Bristol-Myers said it continues to monitor the regulatory situation closely.

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