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Novo Nordisk (NVO) to Begin Study on Oral Semaglutide in Obesity

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Denmark-based Novo Nordisk A/S (NVO - Free Report) announced that it has decided to initiate a phase IIIa study with oral semaglutide 50 mg in obesity. The decision comes after completion of the phase IIIa STEP study which evaluated once-weekly subcutaneous (sc) semaglutide 2.4 mg for the given indication.

The pivotal phase IIIa study is expected to begin in the second half of 2021. The study will evaluate the safety and efficacy of oral semaglutide versus placebo in approximately 1,000 people with obesity or overweight with comorbidities.

Please note that, Ozempic (semaglutide) 2.4 mg, a once-weekly glucagon-like peptide-1 (GLP-1) analog for weight management, is currently under review in the United States and in the EU as a treatment for adults with obesity. The regulatory filings were based on data from the phase IIIa STEP study which enrolled around 4,500 adults with overweight or obesity.

Shares of Novo Nordisk have rallied 6.3% so far this year compared with the industry’s increase of 3.2%.

price chart for NVO


We note that in December 2017, the FDA-approved Ozempic once-daily pre-filled pen to improve glycemic control in type II diabetes patients. In January 2020, the drug was approved in the United States for cardiovascular risk reduction in people with type II diabetes and established cardiovascular diseases.

Ozempic (0.5 mg and 1.0 mg doses) is currently approved in the United States and in the EU for the treatment of type II diabetes in adults.

We remind investors that oral semaglutide is marketed in the United Sates, the EU and in Japan under the brand name Rybelsus for treating type II diabetes as an adjunct to diet and exercise for adults with uncontrolled conditions.

Zacks Rank & Stocks to Consider

Novo Nordisk currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the healthcare sector include Bristol Myers Squibb Company (BMY - Free Report) , Catalent, Inc. (CTLT - Free Report) and Repligen Corporation (RGEN - Free Report) , 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.

Bristol Myers’ earnings estimates have been revised 0.3% upward for 2021 and 0.8% upward for 2022 over the past 60 days. The stock has increased 6.9% year to date.

Catalent’s earnings estimates have been revised 1.8% upward for 2021 and 1.5% upward for 2022 over the past 60 days. The stock has inched up 6.9% year to date.

Repligen’s earnings estimates have been revised 15.1% upward for 2021 and 9.8% upward for 2022 over the past 60 days. The stock has rallied 13.6% year to date.

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