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Bristol Myers Unveils More Positive Data On Ulcerative Colitis Candidate Zeposia

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Bristol Myers Unveils More Positive Data On Ulcerative Colitis Candidate Zeposia
  • Bristol-Myers Squibb & Co (NYSE: BMYreleased positive new data on its ulcerative colitis (UC) candidate Zeposia (ozanimod) at Digestive Disease Week (DDW), highlighting the drug's clinical benefits and safety profile. 
  • According to one study, 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.
  • Parallel reductions in inflammatory biomarkers were seen at Weeks 5 and 10 with Zeposia versus placebo.
  • Other results showed that Zeposia as maintenance treatment led to an increased likelihood of achieving corticosteroid-free remission vs. placebo at week 52.
  • A pooled analysis also confirmed the safety of the drug over the long term.
  • Zeposia was launched in March 2020 in the U.S. as a multiple sclerosis treatment.
  • The FDA has granted the drug Priority Review for the UC indication with a PDUFA date of May 30.
  • A regulatory decision from the EMA is expected in the second half of 2021.
  • Price Action: BMY shares are up 0.22% at $67.20 during the premarket session on the last check Monday.
 

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Posted-In: Briefs ulcerative colitisBiotech News Health Care FDA General

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