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NVO Reports Strong Phase III Diabetes Data for Children & Adolescents
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Key Takeaways
NVO's PIONEER TEENS study met its primary goal, cutting HbA1c by 0.83% vs. placebo at 26 weeks.
NVO tested oral semaglutide in 132 patients aged 10-17 years, showing a well-tolerated safety profile.
NVO plans US/EU filings in H2 2026. The therapy could become the first oral GLP-1 for youth with T2D.
Novo Nordisk (NVO - Free Report) announced positive top-line results from the phase IIIa PIONEER TEENS study, evaluating oral semaglutide, a glucagon-like peptide 1 receptor agonist (GLP-1 RA), in children and adolescents aged 10 to 17 years with type II diabetes (T2D).
Key Highlights of NVO’s PIONEER TEENS Study
The phase IIIa PIONEER TEENS study evaluated oral semaglutide in 132 children and adolescents aged 10 to 17 years with T2D at maximum tolerated doses (3 mg, 7 mg or 14 mg) versus placebo. Patients were given once-daily doses of oral semaglutide alongside standard background therapy. The primary endpoint of the study was to assess the change in HbA1c (a measure of blood sugar control) from baseline.
The study demonstrated a statistically significant and superior reduction in HbA1c by 0.83% versus placebo at 26 weeks and showed a well-tolerated safety profile consistent with prior semaglutide studies.
Type II diabetes in children and adolescents is a serious, progressive disease linked to a higher risk of early adult mortality. Treatment options for glycemic control remain limited, highlighting a significant unmet need. The global adolescent T2D population is projected to reach approximately 20.9 million.
Year to date, shares of Novo Nordisk have plunged 24.3% compared with the industry’s 5.3% decline.
Image Source: Zacks Investment Research
More on NVO’s Semaglutide
NVO already markets the oral semaglutide under the brand name “Rybelsus” as an adjunct to diet and exercise for the treatment of adult patients with T2D in the United States and the European Union. Rybelsus is also approved to lower the risk of major adverse cardiovascular events in high-risk T2D patients.
The company also markets semaglutide globally as “Ozempic”, a once-weekly injectable therapy to improve blood sugar (glucose) in adults with T2D and reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes with known heart disease.
The FDA recently approved an oral version of Ozempic (1.5 mg, 4 mg and 9 mg) for adult T2D patients, which NVO is planning to launch in the second quarter of 2026. A supplemental application for a higher 25 mg tablet is also under review, with a regulatory decision expected by the end of 2026.
Based on the phase IIIa PIONEER TEENS study data, NVO intends to seek regulatory approval for oral semaglutide in children and adolescents aged 10 to 17 years with T2D for both Rybelsus and oral Ozempic in the United States and the European Union in the second half of the year.
NVO’s Zacks Rank & Stocks to Consider
Novo Nordisk currently carries a Zacks Rank #3 (Hold).
Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 earnings per share have risen from $2.55 to $2.87. Over the same period, EPS estimates for 2027 have surged from $2.85 to $3.25. CPRX shares have gained 18.6% year to date.
Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have risen from $2.89 to $3.08. Over the same period, EPS estimates for 2027 have surged from $3.22 to $3.41. INDV shares have lost 7.6% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 74.53%.
Over the past 60 days, estimates for ANI Pharmaceuticals’ 2026 earnings per share have increased from $8.22 to $9.02. Over the same period, EPS estimates for 2027 have risen from $9.90 to $10.24. Year to date, shares of ANIP have lost 1.1%.
ANI Pharmaceuticals' earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.
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NVO Reports Strong Phase III Diabetes Data for Children & Adolescents
Key Takeaways
Novo Nordisk (NVO - Free Report) announced positive top-line results from the phase IIIa PIONEER TEENS study, evaluating oral semaglutide, a glucagon-like peptide 1 receptor agonist (GLP-1 RA), in children and adolescents aged 10 to 17 years with type II diabetes (T2D).
Key Highlights of NVO’s PIONEER TEENS Study
The phase IIIa PIONEER TEENS study evaluated oral semaglutide in 132 children and adolescents aged 10 to 17 years with T2D at maximum tolerated doses (3 mg, 7 mg or 14 mg) versus placebo. Patients were given once-daily doses of oral semaglutide alongside standard background therapy. The primary endpoint of the study was to assess the change in HbA1c (a measure of blood sugar control) from baseline.
The study demonstrated a statistically significant and superior reduction in HbA1c by 0.83% versus placebo at 26 weeks and showed a well-tolerated safety profile consistent with prior semaglutide studies.
Type II diabetes in children and adolescents is a serious, progressive disease linked to a higher risk of early adult mortality. Treatment options for glycemic control remain limited, highlighting a significant unmet need. The global adolescent T2D population is projected to reach approximately 20.9 million.
Year to date, shares of Novo Nordisk have plunged 24.3% compared with the industry’s 5.3% decline.
Image Source: Zacks Investment Research
More on NVO’s Semaglutide
NVO already markets the oral semaglutide under the brand name “Rybelsus” as an adjunct to diet and exercise for the treatment of adult patients with T2D in the United States and the European Union. Rybelsus is also approved to lower the risk of major adverse cardiovascular events in high-risk T2D patients.
The company also markets semaglutide globally as “Ozempic”, a once-weekly injectable therapy to improve blood sugar (glucose) in adults with T2D and reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes with known heart disease.
The FDA recently approved an oral version of Ozempic (1.5 mg, 4 mg and 9 mg) for adult T2D patients, which NVO is planning to launch in the second quarter of 2026. A supplemental application for a higher 25 mg tablet is also under review, with a regulatory decision expected by the end of 2026.
Based on the phase IIIa PIONEER TEENS study data, NVO intends to seek regulatory approval for oral semaglutide in children and adolescents aged 10 to 17 years with T2D for both Rybelsus and oral Ozempic in the United States and the European Union in the second half of the year.
NVO’s Zacks Rank & Stocks to Consider
Novo Nordisk currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Catalyst Pharmaceuticals (CPRX - Free Report) and Indivior Pharmaceuticals (INDV - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy), and ANI Pharmaceuticals (ANIP - Free Report) , which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 earnings per share have risen from $2.55 to $2.87. Over the same period, EPS estimates for 2027 have surged from $2.85 to $3.25. CPRX shares have gained 18.6% year to date.
Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have risen from $2.89 to $3.08. Over the same period, EPS estimates for 2027 have surged from $3.22 to $3.41. INDV shares have lost 7.6% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 74.53%.
Over the past 60 days, estimates for ANI Pharmaceuticals’ 2026 earnings per share have increased from $8.22 to $9.02. Over the same period, EPS estimates for 2027 have risen from $9.90 to $10.24. Year to date, shares of ANIP have lost 1.1%.
ANI Pharmaceuticals' earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.