Bristol Myers (BMY) receives positive CHMP opinion for Zeposia in UC
Bristol-Myers Squibb Company BMY announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (“CHMP”) has issued a favorable opinion and recommended approval of its sphingosine-1-phosphate (S1P) receptor modulator Zeposia ( ozanimod) for the treatment of moderate to severe active ulcerative colitis (“UC”) in adult patients who have had an inadequate response, loss of response or were intolerant to conventional therapy or a biological agent. The opinion will now be considered by the European Commission.
The positive CHMP opinion was based on data from the pivotal phase III True North study, which evaluated Zeposia as an induction and maintenance treatment versus placebo in the given patient population. Data from the same study showed that treatment with Zeposia led to clinically significant improvements in key clinical, endoscopic and mucosal healing parameters.
According to the company, if approved, Zeposia will become the first and only oral S1P receptor modulator to be approved for the treatment of UC in the European Union.
Bristol Myers shares have fallen 5.9% so far this year compared to the industry’s 11% drop.
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In May 2021, the FDA approved Zeposia for the treatment of adult patients with moderate to severe active UC, a chronic inflammatory bowel disease.
Note that Zeposia is already approved in the United States for the treatment of adults with recurrent forms of multiple sclerosis or RMS. The European Commission also approved Zeposia for the treatment of adult patients with relapsing-remitting multiple sclerosis or RRMS in May 2020.
Bristol Myers is currently evaluating Zeposia in an open-label extension study to assess the long-term profile of the drug for the treatment of moderate to severe active UC.
Zeposia is also being evaluated for the treatment of moderately to severely active Crohn’s disease in the ongoing phase III YELLOWSTONE study.
In the first six months of 2021, Zeposia generated sales worth $ 46 million. The potential expansion of the drug’s label is expected to boost sales in 2021 and beyond.
Zacks ranking and actions to take into account
Bristol Myers currently wears a Zacks Rank # 3 (Hold). Top-ranked stocks in the biotech sector include Intercept Pharmaceuticals, Inc. ICTP, Athenex, Inc. ATNX and Amicus Therapeutics, Inc. FOLD, all currently wearing a Zacks Rank # 2 (Buy). You can see The full list of today’s Zacks # 1 Rank (Strong Buy) stocks here.
Intercept Pharmaceuticals’ loss per share estimates have declined 2.6% for 2021 and 8.3% for 2022, over the past 60 days.
Athenex’s loss per share estimates have declined 9% for 2021 and 9.2% for 2022, over the past 60 days.
Amicus Therapeutics’ loss per share estimates have declined 1.3% for 2021 and 37.5% for 2022, over the past 60 days.
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