Hims & Hers (HIMS) stock fell as much as 27% Monday after the Food and Drug Administration announced Friday that the agency planned to take “decisive steps” to crack down on the sale of compounded GLP-1s, such as those sold by the company.
The company is also facing a lawsuit filed on Monday by Novo Nordisk (NVO), the maker of Ozempic, which seeks to bar Hims & Hers from selling compounded versions of its weight-loss drugs.
In its Friday statement, the FDA announced “its intent to take decisive steps to restrict GLP-1 active pharmaceutical ingredients (APIs) intended for use in non-FDA-approved compounded drugs that are being mass-marketed by companies — including Hims & Hers and other compounding pharmacies — as similar alternatives to FDA-approved drugs.”
Popular GLP-1 drugs include Novo Nordisk’s Ozempic and Eli Lilly’s (LLY) Mounjaro, among other products on the market.
Shares ended the day down just over 16%.
Hims & Hers sells cheaper versions of these drugs directly to consumers in “compounded” forms, which differ slightly from FDA-approved versions but contain the same active ingredient. In a statement, Hims & Hers called Novo’s lawsuit was the latest example of, “Big Pharma…weaponizing the US judicial system to limit consumer choice.”
In its statement on Friday, the FDA also said it was “taking steps to combat misleading direct-to-consumer advertising and marketing following warning letters that were sent in the fall of 2025.”
The statement added: “In promotional materials, companies cannot claim that non-FDA-approved compounded products are generic versions or the same as drugs approved by FDA. They also cannot state compounded drugs use the same active ingredient as the FDA-approved drugs or that compounded drugs are clinically proven to produce results for the patient.”
With Monday’s decline, Hims & Hers stock is down about 50% this year. In late February 2025, the stock closed as high as $68 per share. On Monday morning, shares were trading below $17.
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