Bristol-Myers' Zeposia Scores FDA Approval For Ulcerative Colitis

  • The FDA has approved Bristol Myers Squibb & Co's BMY Zeposia (ozanimod) 0.92 mg for the treatment of adults with moderately to severely active ulcerative colitis (UC), a chronic inflammatory bowel disease (IBD).
  • A European marketing application for Zeposia for moderately to severely active UC is currently under review, with a regulatory decision expected in the second half of 2021.
  • The FDA approved Zeposia for relapsing forms of multiple sclerosis (RMS) in March 2020. The European Commission approved Zeposia for relapsing-remitting multiple sclerosis (RRMS) in May 2020.
  • Earlier this week, the company released new data on Zeposia, showing that induction therapy with Zeposia improved symptoms of rectal bleeding and stool frequency in moderately to severely active UC patients as early as week two and maintained through week 10.
  • Price Action: BMY shares are up 0.41% at $65.98 in the premarket session on the last check Friday.
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