UPDATE: Shares of Novo Nordisk A/S skyrocketed by 7.36% during pre-market trading on Tuesday as news broke of the U.S. Food and Drug Administration (FDA) approving its groundbreaking weight-loss pill, Wegovy. This approval, confirmed on Monday, marks a significant milestone as it is the first of its kind globally.
The FDA’s green light means that the pill, starting at a dose of 1.5 milligrams, will hit pharmacies and select telehealth providers in early January 2024, priced at $149 per month. Patients who prefer to pay out-of-pocket can access the pill through President Donald Trump’s direct-to-consumer platform, TrumpRx, thanks to a recent agreement with his administration.
This approval comes at a critical time for Novo Nordisk, which has faced a tumultuous year marked by board conflicts, supply chain difficulties, and a competitive bidding war with Pfizer (NYSE:PFE). Notably, this development positions Novo Nordisk ahead of its rival, Eli Lilly (NYSE:LLY), in the race to dominate the lucrative weight-loss drug market.
In addition to Wegovy’s approval, Novo Nordisk is also navigating the submission of a New Drug Application (NDA) for CagriSema, a weekly combination obesity shot that integrates a long-acting amylin analogue with the GLP-1 receptor agonist, semaglutide. If granted approval, CagriSema would offer a pioneering injectable GLP-1 receptor agonist and amylin analogue combination treatment, potentially expanding Novo Nordisk’s influence in the weight-loss sector.
While this announcement has boosted investor confidence momentarily, the company has struggled with stock performance throughout the year. Novo Nordisk’s shares have plummeted by 45.04% year-to-date, as of data from Benzinga Pro. The stock recently closed at $88.33 after a slight increase of 0.02% on Monday.
In November, the U.S. Centers for Medicare & Medicaid Services (CMS) announced lower negotiated prices for 15 high-cost drugs, set to take effect in 2027. This will impact Novo Nordisk’s GLP-1 drugs, including semaglutide (Wegovy, Ozempic, Rybelsus), which will see a monthly cost of $274 under the new pricing structure.
Despite the recent surge in share value due to Wegovy’s approval, Novo Nordisk’s stock has continued to face headwinds, particularly following disappointing results from the REDEFINE 2 phase 3 trial of CagriSema. Analysts have noted that the company revised its 2025 sales growth forecast down multiple times, raising concerns among investors regarding its future performance.
As Novo Nordisk capitalizes on this pivotal moment, stakeholders are eager to see how the approval of Wegovy will influence market dynamics, especially with the impending competition from Eli Lilly and others in the weight-loss drug arena.
Stay tuned for further developments as this story unfolds, and watch for the rollout of Wegovy in early January.
