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Bristol Myers' (BMY) Zeposia Gets FDA Nod for Ulcerative Colitis

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Bristol-Myers Squibb Company BMY announced that the FDA has granted approval to its sphingosine-1-phosphate (S1P) receptor modulator Zeposia (ozanimod) for the treatment of adult patients with moderate-to-severe active ulcerative colitis (“UC”), a chronic inflammatory bowel disease.

Following the nod, the once-daily oral Zeposia (0.92 mg) became the first and only S1P receptor modulator to be approved for patients with moderate-to-severe active UC. Notably, this is the second indication for Zeposia to be approved by the FDA.

The approval was based on data from the pivotal phase III study – True North – which evaluated Zeposia as an induction and maintenance therapy versus placebo in adults with active UC. The study met its primary endpoint by demonstrating significant improvements in clinical remission on treatment with Zeposia versus placebo, as well as all key secondary endpoints (clinical response, endoscopic improvement and endoscopic-histologic mucosal improvement) at week 10 and week 52 of treatment.

Zeposia is currently under review in Europe for the UC indication, with a decision from the European Medicines Agency expected in the second half of 2021.

Shares of Bristol Myers have increased 5.9% so far this year against the industry’s decrease of 4.9%.

price chart for BMY
price chart for BMY


In March 2020, the FDA approved Zeposia for the treatment of adults with relapsing forms of multiple sclerosis. Subsequently, the drug was approved in Europe for the treatment of adult patients with relapsing remitting multiple sclerosis in May last year.

In the first quarter of 2021, Zeposia generated sales worth $18 million. Label expansion of the drug is likely to boost sales further in 2021 and beyond.

Bristol Myers is currently evaluating Zeposia in an open-label extension study, which is designed to assess the longer-term profile of the drug for the treatment of moderate-to-severe active UC.

Also, the company is evaluating Zeposia in the ongoing phase III YELLOWSTONE study for the treatment of moderate-to-severe active Crohn’s disease.

Zacks Rank & Stocks to Consider

Bristol Myers currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the healthcare sector include Akero Therapeutics, Inc. AKRO, Avid Bioservices, Inc. CDMO and Illumina, Inc. ILMN, all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Akero Therapeutics’ loss per share estimates have narrowed 34% for 2021 and 35.7% for 2022 over the past 60 days. The stock has inched up 2.7% year to date.

Avid Bioservices’ earnings estimates have been revised 80% upward for 2021 and 53.8% upward for 2022 over the past 60 days. The stock has soared 80.3% year to date.

Illumina’s earnings estimates have been revised 13.8% upward for 2021 and 10.8% upward for 2022 over the past 60 days. The stock has rallied 10.5% year to date.

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