We use cookies to understand how you use our site and to improve your experience.
This includes personalizing content and advertising.
By pressing "Accept All" or closing out of this banner, you consent to the use of all cookies and similar technologies and the sharing of information they collect with third parties.
You can reject marketing cookies by pressing "Deny Optional," but we still use essential, performance, and functional cookies.
In addition, whether you "Accept All," Deny Optional," click the X or otherwise continue to use the site, you accept our Privacy Policy and Terms of Service, revised from time to time.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Novo Nordisk's Awiqli Gets FDA Approval for Type II Diabetes
Read MoreHide Full Article
Key Takeaways
Novo Nordisk won FDA approval for Awiqli, a once-weekly basal insulin for adults with type II diabetes.
Awiqli showed strong HbA1c reduction in the phase IIIa ONWARDS studies vs. daily basal insulin.
NVO plans a U.S. launch of the FlexTouch device in the second half of 2026 after global approvals.
Novo Nordisk (NVO - Free Report) announced that the FDA has approved Awiqli injection as the first and only once-weekly, long-acting basal insulin icodec for adults with type II diabetes (T2D). The therapy is indicated as an adjunct to diet and exercise to improve glycemic control in T2D patients.
Awiqli is already approved in the European Union and several other countries for the treatment of diabetes in adults, with indications varying by market. The approval of additional diabetes treatments is reassuring, as it further strengthens Novo Nordisk’s strong diabetes portfolio.
Year to date, shares of NVO have lost 28.5% compared with the industry’s 2.9% decline.
Image Source: Zacks Investment Research
FDA Approves NVO’s Awiqli Based on Phase IIIa ONWARDS Program
The FDA approval is supported by data from the phase IIIa ONWARDS clinical program, which included four studies involving approximately 2,680 adults with uncontrolled T2D. In these studies, Awiqli was evaluated in combination with mealtime insulin or together with common diabetes medicines, including oral drugs and GLP-1 receptor agonists.
The drug demonstrated robust efficacy in achieving the primary endpoint of HbA1c reduction, compared with daily basal insulin. Its safety profile was consistent with that of the established basal insulin class.
Novo Nordisk anticipates introducing Awiqli in the FlexTouch device in the United States in the second half of 2026.
Novo Nordisk has a strong presence in the diabetes care market, with one of the broadest portfolios in the industry. Novo Nordisk’s success in recent years has been driven by the sales of Ozempic and Rybelsus (oral) for type II diabetes and Wegovy for obesity.
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 (EPS) have risen from $2.55 to $2.78. CPRX shares have gained 24.1% over the past six months.
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 ADMA Biologics’ 2026 EPS have increased from 85 cents to 96 cents. ADMA shares have lost 43.6% over the past six months.
ADMA Biologics’ earnings beat estimates in one of the trailing three quarters, matched once and missed on the remaining occasion, with the average negative surprise being 1.79%.
Over the past 60 days, estimates for Inovio Pharmaceuticals’ 2026 loss per share have narrowed from $1.26 to $1.12. INO shares have plunged 36.5% over the past six months.
Inovio Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 57.94%.
Zacks' 7 Best Strong Buy Stocks (New Research Report)
Valued at $99, click below to receive our just-released report
predicting the 7 stocks that will soar highest in the coming month.
View the Zacks #1 Rank List
Image: Bigstock
Novo Nordisk's Awiqli Gets FDA Approval for Type II Diabetes
Key Takeaways
Novo Nordisk (NVO - Free Report) announced that the FDA has approved Awiqli injection as the first and only once-weekly, long-acting basal insulin icodec for adults with type II diabetes (T2D). The therapy is indicated as an adjunct to diet and exercise to improve glycemic control in T2D patients.
Awiqli is already approved in the European Union and several other countries for the treatment of diabetes in adults, with indications varying by market. The approval of additional diabetes treatments is reassuring, as it further strengthens Novo Nordisk’s strong diabetes portfolio.
Year to date, shares of NVO have lost 28.5% compared with the industry’s 2.9% decline.
Image Source: Zacks Investment Research
FDA Approves NVO’s Awiqli Based on Phase IIIa ONWARDS Program
The FDA approval is supported by data from the phase IIIa ONWARDS clinical program, which included four studies involving approximately 2,680 adults with uncontrolled T2D. In these studies, Awiqli was evaluated in combination with mealtime insulin or together with common diabetes medicines, including oral drugs and GLP-1 receptor agonists.
The drug demonstrated robust efficacy in achieving the primary endpoint of HbA1c reduction, compared with daily basal insulin. Its safety profile was consistent with that of the established basal insulin class.
Novo Nordisk anticipates introducing Awiqli in the FlexTouch device in the United States in the second half of 2026.
Novo Nordisk has a strong presence in the diabetes care market, with one of the broadest portfolios in the industry. Novo Nordisk’s success in recent years has been driven by the sales of Ozempic and Rybelsus (oral) for type II diabetes and Wegovy for obesity.
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) , ADMA Biologics (ADMA - Free Report) and Inovio Pharmaceuticals (INO - Free Report) . While CPRX sports a Zacks Rank #1 (Strong Buy), ADMA and INO carry a Zacks Rank #2 (Buy) each at present. 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 (EPS) have risen from $2.55 to $2.78. CPRX shares have gained 24.1% over the past six months.
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 ADMA Biologics’ 2026 EPS have increased from 85 cents to 96 cents. ADMA shares have lost 43.6% over the past six months.
ADMA Biologics’ earnings beat estimates in one of the trailing three quarters, matched once and missed on the remaining occasion, with the average negative surprise being 1.79%.
Over the past 60 days, estimates for Inovio Pharmaceuticals’ 2026 loss per share have narrowed from $1.26 to $1.12. INO shares have plunged 36.5% over the past six months.
Inovio Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 57.94%.