Hims & Hers Stock Crashes After FDA Announces Plans to Take 'Decisive Steps' Against GLP-1 Compounds
•February 9, 2026
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Companies Mentioned
Why It Matters
The crackdown threatens Hims & Hers’ low‑cost, direct‑to‑consumer GLP‑1 model, potentially eroding a fast‑growing revenue stream and signaling tighter oversight for telehealth compounding firms.
Key Takeaways
- •FDA targets non‑approved compounded GLP‑1 APIs
- •Hims & Hers shares fell 27% intraday, 16% close
- •Novo Nordisk sued to block Hims’ compounded weight‑loss drugs
- •Company claims big pharma weaponizes legal system
- •Stock down ~50% year‑to‑date
Pulse Analysis
The FDA’s announcement marks a pivotal shift in how compounded GLP‑1 products are regulated. While GLP‑1 agonists such as Ozempic and Mounjaro have surged in popularity for weight‑loss and diabetes management, the agency is drawing a line at non‑approved formulations that are mass‑marketed without rigorous clinical validation. By targeting the active pharmaceutical ingredients themselves, the FDA aims to curb misleading advertising and protect patients from unverified efficacy claims, a stance that could reshape the broader compounding pharmacy landscape.
For Hims & Hers, the regulatory pressure compounds an existing legal challenge from Novo Nordisk, which seeks an injunction against the company’s cheaper, compounded alternatives. The dual blow has rattled investors, driving the stock down 27% during intraday trading and leaving it over 16% lower at market close. The firm’s business model—leveraging telehealth platforms to sell lower‑priced, directly shipped compounds—relies on a regulatory gray area that now appears to be closing. Revenue forecasts tied to GLP‑1 sales may need revision, and the company could face additional compliance costs or be forced to pivot toward fully FDA‑approved products.
Industry observers see this as a bellwether for the telehealth and compounding sectors. As the FDA tightens oversight, companies will likely invest more in clinical trials, transparent labeling, and partnership with established manufacturers to maintain market access. Consumers may see fewer low‑cost alternatives, but the move could also foster greater confidence in the safety and efficacy of marketed therapies. Stakeholders should monitor forthcoming FDA guidance and potential settlement outcomes, which will dictate the next phase of growth for digital health firms navigating the evolving pharmaceutical regulatory environment.
Hims & Hers stock crashes after FDA announces plans to take 'decisive steps' against GLP-1 compounds
Hims & Hers stock fell as much as 27% Monday after FDA announcement
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%.
NYSE – Nasdaq Real‑Time Price USD
17.24 – 2.09 (-10.81%)
At close: February 10 at 4:00:03 PM EST
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 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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