Hims & Hers Stock Plummets After FDA Targets Compounded GLP-1s

Feb 10, 2026, 2:28 AM

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Hims & Hers (HIMS) stock fell dramatically on Monday, losing as much as 27% after the Food and Drug Administration (FDA) announced its intention to take "decisive steps" against the sale of compounded GLP-1 drugs, which include products sold by the company.

The FDA's announcement, made on Friday, highlighted concerns about non-FDA-approved compounded drugs being marketed as alternatives to approved medications. This crackdown specifically targets GLP-1 active pharmaceutical ingredients (APIs), which have gained popularity for their weight-loss benefits.

In addition to regulatory pressures, Hims & Hers is facing a lawsuit filed by Novo Nordisk, the manufacturer of the widely used GLP-1 medication Ozempic. The legal action seeks to prevent Hims & Hers from continuing to sell its compounded versions of these weight-loss drugs.

The FDA's statement emphasized the importance of consumer protection, indicating that companies cannot claim that non-FDA-approved compounded products are equivalent to or generic versions of FDA-approved drugs. It also stated that such companies must not assert that their compounded drugs use the same active ingredients or are clinically proven to yield similar results as approved medications.

The ramifications of these developments have already impacted Hims & Hers' stock performance, which has seen a steep decline of approximately 50% this year. The stock, which reached a high of $68 per share in late February 2025, was trading below $17 on Monday morning following the announcement.

Hims & Hers markets cheaper compounded versions of GLP-1 drugs directly to consumers, which differ slightly from their FDA-approved counterparts but contain the same active ingredients. In response to the lawsuit from Novo Nordisk, Hims & Hers characterized the legal action as an attempt by "Big Pharma" to limit consumer choices through the judicial system.

As the landscape for compounded medications continues to evolve, Hims & Hers will need to navigate these regulatory challenges carefully. The company's ability to adapt to the FDA's restrictions and the outcomes of the ongoing litigation will be critical in determining its future market position and stock performance.

The FDA's commitment to cracking down on misleading advertising practices in the direct-to-consumer market further complicates the situation for Hims & Hers. The agency has expressed its intention to combat deceptive marketing, which may have implications for how the company promotes its products in the coming months.

With the stock market reacting sharply to these developments, investors will be closely monitoring Hims & Hers' navigation through this turbulent regulatory environment. The combination of legal challenges and potential changes in the market landscape could significantly influence the company's future trajectory and profitability.

In conclusion, the recent FDA announcement and the impending lawsuit from Novo Nordisk represent significant hurdles for Hims & Hers, leading to a drastic drop in its stock price and raising questions about its business strategy going forward. As the situation unfolds, stakeholders will be keenly observing how these factors play out in the competitive landscape of weight-loss medications.

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