Bristol-Myers Squibb Company BMY announced positive topline data from the pivotal phase III True North study, which evaluated its newly-approved multiple sclerosis drug Zeposia (ozanimod) for a new indication, moderate-to-severe ulcerative colitis (UC). The study met both primary endpoints, demonstrating highly statistically significant results for induction of clinical remission at week 10 and in maintenance at week 52.
The True North study, which evaluated Zeposia as an induction and maintenance therapy for adult patients with UC also met key secondary endpoints of clinical response and endoscopic improvement in induction at week 10 and in maintenance at week 52.
Per the company, the safety profile of Zeposia in this ulcerative colitis study was similar to that observed in previously reported studies.
Shares of Bristol Myers have declined 5.5% so far this year compared with the industry’s decrease of 1.7%.
Notably, in March 2020, the FDA approved Zeposia for the treatment of adults with relapsing forms of multiple sclerosis (RMS) including those with clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. The oral drug (0.92 mg) was launched in the United States earlier this week. Zeposia was added to Bristol-Myers’ portfolio with the 2019 acquisition of Celgene.
Last month, the European Commission (EC) also approved Zeposia for RMS.
Significantly, Bristol Myers is also evaluating Zeposia in the ongoing phase III YELLOWSTONE study for the treatment of moderately-to-severely active Crohn’s disease.
A potential label expansion of the drug for additional indications will boost its sales in the days ahead.
Zacks Rank & Other Stocks to Consider
Bristol Myers currently carries a Zacks Rank #2 (Buy). Other top-ranked stocks in the large-cap pharma sector include Eli Lilly and Company LLY, AbbVie Inc. ABBV and Innoviva, Inc. INVA, all sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Eli Lilly’s earnings have been revised 0.6% upward for 2020 and 1% for 2021 over the past 60 days. The stock has gained 17.1% year to date.
AbbVie earnings have been revised 14.2% upward for 2020 and 6.6% for 2021 over the past 60 days. The stock has inched up 2.8% year to date.
Innoviva’s earnings have been revised 37.9% upward for 2021 over the past 60 days.
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