Novo Nordisk NVO announced positive results from a phase IIIa study, OASIS 1, in the global OASIS program for a once-daily oral formulation of semaglutide in obesity.
OASIS is a phase III program evaluating once-daily oral semaglutide 25 mg and 50 mg for obesity care. This program consists of four trials evaluating the same in adults who are obese or overweight and have one or more comorbidities.
Among these trials, OASIS 1 is a 68-week efficacy and safety trial comparing once-daily oral semaglutide 50 mg for weight management versus placebo in 667 adults with obesity or overweight with one or more comorbidities.
The study achieved its primary endpoint, with people showing statistically significant and superior weight loss at week 68 with oral semaglutide 50 mg compared with placebo.
People treated with oral semaglutide 50 mg achieved a statistically significant weight loss of 17.4% after 68 weeks compared with a 1.8% reduction with placebo when evaluating the effects of treatment, provided all people adhered to treatment. Additionally, 89.2% of those who received oral semaglutide 50 mg were able to attain a weight loss of 5% or more after 68 weeks compared with only 24.5% with a placebo.
Oral semaglutide 50 mg was found to have a safe and well-tolerated profile in the study and most common adverse events were gastrointestinal, which were most prominent during dose escalation. Majority of the adversities were mild to moderate, weaned off over time and were consistent with the GLP-1 receptor agonist class. Novo Nordisk expects to file for regulatory approval in the US and the EU in 2023.
Novo Nordisk expects to file for regulatory approval of the candidate in the US and the EU later in the year.
Shares of Novo Nordisk have gained 21.4% in the year so far compared with the industry’s rise of 2.2%.
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We remind investors that injectable semaglutide 2.4 mg is already approved under the brand name Wegovy for obesity.
Wegovy was recently approved in Japan for the treatment of obesity.
Wegovy sales increased significantly in the first quarter of 2023 after the company solved supply issues in the United States for the drug.
Earlier in February 2023, Novo Nordisk initiated REDEFINE 2, a 68-week phase IIIa trial comparing CagriSema (2.4 mg semaglutide and 2.4 mg cagrilintide) with placebo in people with overweight or obesity and type 2 diabetes. NVO also has another approved drug, Saxenda (liraglutide), for obesity care.
Novo Nordisk's first-quarter 2023 earnings matched estimates while revenues miss the same. Ozempic (semaglutide injection for type 2 diabetes) and Rybelsus have experienced great traction in the market since launch.
Shares of Pfizer PFE surged on May 22, 2023, following the publication of encouraging data on the investigational drug danuglipron for the treatment of type 2 diabetes and obesity in the JAMA Network medical journal. In a phase II randomized clinical study in 411 adults with type 2 diabetes, danuglipron reduced glycated hemoglobin and fasting plasma glucose (at all doses) and body weight (at the highest doses) at week 16 compared with placebo.
Investors were impressed as the weight loss observed with Pfizer’s danuglipron is of a similar magnitude to that observed in the phase II data for oral semaglutide.
Novo Nordisk currently sports a Zacks Rank #1 (Strong Buy).
Other top-ranked stocks in the healthcare sector include Novartis NVS and Ligand Pharmaceuticals LGND. While LGND sports the same rank as NVO, Novartis carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 30 days, earnings estimates for LGND have increased by 63 cents to $4.79. LGND topped earnings estimates in two of the last four quarters and missed in the remaining two, the average surprise being 21.50%.
Over the past 30 days, NVS’ earnings estimates have increased to $6.67 from $6.57 for 2023. Novartis also surpassed estimates in all the trailing four quarters, the average surprise being 5.15%.
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