Drugmaker Novo Nordisk (NVO) announced on Friday that the U.S. Food and Drug Administration (FDA) has accepted its application to review an oral version of its popular weight loss drug, Wegovy (semaglutide). If approved, the pill would become the first oral GLP-1 drug specifically indicated for weight loss, which would expand on the success of the injectable version. Novo is seeking FDA approval for a once-daily 25 mg dose intended for overweight and obese adults who also have at least one related health condition, such as diabetes or hypertension.
This is a major step for the Danish company as it looks to offer patients a more convenient alternative to injections. In addition to weight management, Novo is asking the FDA to approve the oral version of Wegovy for reducing the risk of major adverse cardiovascular events, such as strokes, in overweight or obese adults with existing cardiovascular disease. The FDA is expected to make a decision on this new drug application in the fourth quarter of 2025. Novo’s application is supported by its OASIS study, which tested the 25 mg oral semaglutide against a placebo in over 300 overweight or obese adults.
Interestingly, Novo’s move comes as competition heats up in the fast-growing weight loss drug market. Indeed, rival Eli Lilly (LLY) is preparing to launch its own oral weight loss treatment, orforglipron, next year. It is also worth noting that, in April, Lilly announced that orforglipron had met its main goal in a Phase 3 trial for adults with type 2 diabetes, which was the first late-stage success for this type of GLP-1 pill.
Is NVO Stock a Good Buy?
Turning to Wall Street, analysts have a Hold consensus rating on NVO stock based on three Buys, five Holds, and one Sell assigned in the past three months, as indicated by the graphic below. Furthermore, the average NVO price target of $83.20 per share implies 20.1% upside potential.
