Shares of Novo Nordisk saw a notable recovery on Friday as comments from the U.S. Food and Drug Administration suggested regulators would clamp down on the broad marketing of unapproved copycat medicines. The company’s American depositary receipts jumped more than 7% in premarket trading, while shares listed in Copenhagen gained over 5%.
The rebound came after a volatile week for the Danish drugmaker. Earlier sessions included a steep decline that accelerated after telehealth provider Hims and Hers Health introduced a substantially cheaper compounded version of Wegovy, priced at $49, prompting investor concern over pricing competition and market share erosion.
FDA Commissioner Marty Makary posted on X that “FDA will take swift action against companies mass-marketing illegal copycat drugs, claiming they are similar to FDA-approved products.” He added a warning about the risks of unapproved treatments: “The FDA cannot verify the quality, safety or effectiveness of non-approved drugs.” The comments did not mention any companies by name.
Market pressure on Novo had intensified earlier in the week after the company issued a pre-release for its 2026 outlook that fell short of analyst expectations. The pre-release showed the company forecasting that both sales and operating profit in 2026 would decline between 5% and 13%.
In explaining the forecast, CEO Mike Doustdar emphasized industry headwinds, stating: “In 2026, Novo Nordisk will face pricing headwinds in an increasingly competitive market.” He also pointed to early signs of success for the firm’s newest therapy format, saying: “However, we are very encouraged by the promising early uptake from the U.S. launch of Wegovy pill, and we remain confident in our ability to drive volume growth over the coming years.”
The outlook marked a break from several years of strong growth at Novo Nordisk. Since the introduction of Wegovy in 2021, the company reported multiple years of double-digit revenue and profit expansion, a performance that helped it become Europe’s most valuable listed company in 2024. The firm attributed the weaker 2026 guidance to a combination of lower realized pricing, particularly in the U.S., intensifying competition, and expected patent expiries for semaglutide in certain markets outside the U.S.
Investors reacted to both the regulatory signal and the company’s guidance, leading to the swing in prices across U.S. and Copenhagen listings. The episode highlights the intersecting pressures of competitive pricing from alternative suppliers and evolving regulatory scrutiny around unapproved compounded treatments.