NVO's Rybelsus Gets FDA Nod to Reduce Heart Risk in Diabetes Patients

Novo Nordisk NVO received FDA approval for a regulatory application seeking the label expansion of its oral GLP-1 drug, Rybelsus (semaglutide), to include cardiovascular (CV) risk reduction in adults with type II diabetes (T2D).  

This approval makes Rybelsus the first and only oral GLP-1 therapy approved to lower the risk of major adverse cardiovascular events (MACE), including CV death, heart attack, or stroke, in high-risk T2D patients, regardless of prior CV history. The indication supports both primary prevention, by managing risk factors in high-risk individuals, and secondary prevention, by reducing the likelihood of recurrent events in those with a previous serious CV event.

Please note that the FDA first approved Rybelsus in 2019 as the only oral GLP-1 therapy to be used alongside diet and exercise for improving blood sugar control in adults with T2D. Last month, Rybelsus’ label was also expanded in the EU to reflect MACE risk reduction in adult T2D patients.

Year to date, shares of Novo Nordisk have plunged 35.2% against the industry’s 5.1% growth.

FDA Clears NVO’s Rybelsus for MACE After Phase III Success

The FDA’s decision is supported by positive data from the phase IIIb SOUL study, which demonstrated that Rybelsus significantly reduced the risk of CV events in this high-risk population, marking an important milestone for the company’s oral GLP-1 platform.

Results from the SOULstudy showed that Rybelsus, in addition to standard of care, achieved a statistically significant 14% relative risk reduction in MACE compared to placebo. Over the study’s four-year follow-up, 12% of patients in the Rybelsus group experienced a CV event compared to 13.8% in the placebo group, representing a 2% absolute risk reduction at three years. Per Novo Nordisk, the SOUL study findings strengthen the growing body of clinical and real-world evidence demonstrating semaglutide’s CV benefits beyond glycemic control, a key concern for people with T2D.

The safety profile of Rybelsus in the SOUL study was generally consistent with previous studies. Serious adverse events were slightly lower in the Rybelsus group compared to placebo, with cardiac disorders and infections/infestations being the most common. However, gastrointestinal side effects and discontinuation rates due to adverse events were higher in the Rybelsus group compared to placebo.

Novo Nordisk also markets its semaglutide medicines as Ozempic and Wegovy injections for diabetes and obesity indications, respectively.

The company has filed a supplemental regulatory application in the United States seeking approval of a 25 mg oral formulation of semaglutide (Wegovy pill) for obesity and CV disease, which could become the first oral GLP-1 therapy for chronic weight management, if approved. A decision is expected later this year. Label expansion is also being sought for Ozempic in treating peripheral artery disease in the United States and the European Union.

By broadening indications and introducing new formulations, Novo Nordisk is reinforcing semaglutide’s role as a cornerstone therapy across diabetes, obesity and cardiometabolic diseases, supporting long-term revenue expansion.

Novo Nordisk A/S Price and Consensus

Novo Nordisk A/S price-consensus-chart | Novo Nordisk A/S Quote

NVO’s Zacks Rank and Stocks to Consider

Novo Nordisk currently carries a Zacks Rank #4 (Sell).

Some better-ranked stocks in the overall medical sector are Chemomab Therapeutics CMMB, Alnylam Pharmaceuticals ALNY and ANI Pharmaceuticals ANIP. While CMMB currently sports a Zacks Rank #1 (Strong Buy), ALNY and ANIP carry a Zacks Rank #2 (Buy) each at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for Chemomab Therapeutics’ 2025 loss per share have narrowed from $2.40 to 60 cents. Loss per share estimates for 2026 have narrowed from $2.80 to $1.00 during the same period. CMMB stock has plunged 55.1% year to date.

Chemomab Therapeutics’ earnings beat estimates in three of the trailing four quarters, while meeting the same on the remaining occasion, with an average surprise of 26.25%.

In the past 60 days, estimates for Alnylam’s 2025 earnings per share have risen from $3.34 to $3.81. During the same period, earnings per share for 2026 have increased from $9.23 to $9.97. Year to date, ALNY’s shares have surged 99.9%.

Alnylam’s earnings beat estimates in three of the trailing four quarters, while meeting the same on the remaining occasion, with an average surprise of 348.36%.

In the past 60 days, estimates for ANI Pharmaceuticals’ 2025 earnings per share have risen from $7.25 to $7.29. During the same period, earnings per share for 2026 have increased from $7.74 to $7.81. Year to date, ANIP’s shares have rallied 66.5%.

ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with an average surprise of 22.66%.

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

This article originally published on Zacks Investment Research (zacks.com).

Zacks Investment Research