Hims & Hers Retreats from Weight-Loss Market Following Regulatory Pressure

Shares of telehealth provider Hims & Hers Health plummeted nearly 15% in pre-market trading on Monday. The sharp decline followed the company's decision to halt sales of its newly launched weight-loss medication after facing significant opposition from pharmaceutical giant Novo Nordisk and the U.S. Food and Drug Administration (FDA).

The company pulled the emergency brake just three days after the product's debut. On Saturday, Hims & Hers announced it would withdraw its semaglutide-based medication from the market. A company statement cited "constructive discussions with stakeholders" as the reason for the reversal.

The product, introduced on February 5, was priced at $49 for the first month and $99 thereafter. It contained semaglutide, the same active ingredient found in Novo Nordisk's blockbuster drugs Wegovy and Ozempic. The Danish pharmaceutical firm reacted strongly, labeling the Hims product "illegal" and threatening legal action. Novo Nordisk accused the telehealth platform of misleading the American public with "copycat GLP-1 products."

Regulatory Crackdown Intensifies

The move comes as the FDA signaled a tougher stance. On Friday, the agency made clear its intention to take action against unapproved GLP-1 medications being marketed by telehealth providers and pharmacies as alternatives to regulated drugs. Market analysts view this as a signal of a broader regulatory offensive.

Should investors sell immediately? Or is it worth buying Hims & Hers?

"This is the FDA declaring war not just on Hims & Hers' Wegovy pill, but on copycat GLP-1 products in general," Soren Lontoft Hansen of AL Sydbank told Reuters. He noted that the development benefits both Novo Nordisk and its competitor Eli Lilly. While Hims shares tumbled, Novo Nordisk's stock jumped more than 8% on Monday.

Super Bowl Ad Campaign Left in Limbo

In a notable twist, all three companies—Hims & Hers, Novo Nordisk, and Eli Lilly—ran advertisements for their weight-loss treatments during Sunday's Super Bowl broadcast. Hims & Hers' multi-million dollar marketing campaign now exists without an associated product to sell.

Investor attention will now turn to the company's upcoming earnings report. Hims & Hers is scheduled to release its fourth-quarter and full-year 2025 financial results on February 23. A conference call is set to begin at 11:00 PM Central European Time. Market participants will be listening closely for management commentary on the company's strategic direction following this significant setback.