The US Food and Drug Administration (FDA) announced that it has resolved a shortage of semaglutide injection products, including Novo Nordisk’s Ozempic and Wegovy. This development comes as shares of Hims & Hers Health plummeted 26% after the FDA warned that it will take action against compounders who produce custom-made alternatives to brand-name drugs.
Semaglutide is a key ingredient in both Ozempic and Wegovy, and its demand has skyrocketed in recent years. Digital health companies like Hims & Hers have prescribed compounded semaglutide as an alternative for patients facing supply hurdles and insurance obstacles.
The FDA allows compounders to produce custom-made medications during shortages but doesn’t review their safety and efficacy. However, the agency will now take action against compounders for violations in the next 60-90 days to avoid disrupting patient treatment.
Hims & Hers shares fell after the announcement as the company’s business model relies heavily on prescribing compounded semaglutide. The company’s weight loss program has been a hit with investors, with shares climbing over 200% last year. Despite this, Hims & Hers is expanding its operations by acquiring a US-based peptide facility and an at-home lab testing facility.
The FDA’s resolution of the semaglutide shortage comes as Novo Nordisk warned that it would continue to face capacity limitations and supply constraints in the future. As a result, digital health companies will need to adapt to changing regulatory landscapes to meet patient needs.
Source: https://www.cnbc.com/2025/02/21/hims-hers-shares-fall-after-fda-says-semaglutide-no-longer-in-shortage.html