New York, Feb 6, 2026, 08:45 EST — Premarket
- HIMS slips 3.8% in premarket trading following FDA chief’s warning on “illegal copycat drugs” crackdown
- This move comes after Hims launched a $49 compounded version of Novo Nordisk’s Wegovy pill
- Traders are keeping an eye on potential FDA enforcement moves and any lawsuits before Hims reports on Feb. 23
Shares of Hims & Hers Health (HIMS.N) dropped 3.8% to $23.48 in premarket trading on Friday. The slide came after FDA Commissioner Marty Makary warned the agency would act quickly against firms mass-marketing “illegal copycat drugs.” The stock had already fallen 3.8% on Thursday and plunged nearly 10% after hours, following Makary’s post on X stating, “The FDA cannot verify the quality, safety, or effectiveness of non-approved drugs.” His comments came after Hims introduced a compounded version of Novo Nordisk’s Wegovy weight-loss medication. 1
The warning strikes at a key vulnerability in Hims’ growth narrative. Investors had backed the company’s expansion beyond hair loss and sexual health into weight loss, betting on cash-paying customers willing to pay for access.
Regulators and drugmakers are pushing back simultaneously. Should the FDA clamp down on compounding enforcement, it could pinch a key product line that’s boosted demand—and put Hims on the defensive over how it produces and markets those drugs.
Hims announced Thursday it will sell a compounded version of Novo Nordisk’s new Wegovy weight-loss pill at $49 for the first month, then $99 for the next four months, beating Novo’s cash price of $149 initially and $199 afterward. The move triggered a selloff in shares of Novo and Eli Lilly. TD Cowen analyst Michael Nedelcovych noted the usual pattern: compounders produce near-identical copies of branded drugs with minor tweaks. 2
GLP-1, or glucagon-like peptide-1, refers to a class of drugs for diabetes and obesity that control appetite and blood sugar. “Compounded” drugs are custom-prepared by pharmacies, typically by adjusting dose or formulation, and they bypass the FDA approval process that branded drugs must undergo.
Novo Nordisk announced plans to pursue legal and regulatory measures against Hims, labeling the company’s actions as “illegal mass compounding” that endangers patient safety. The drugmaker emphasized it is the sole producer of the FDA-approved oral Wegovy pill, which uses SNAC technology to aid semaglutide absorption when taken orally. 3
The stock’s tape has been volatile. Hims shares jumped roughly 14% at Thursday’s open but quickly gave up those gains. Rajiv Leventhal, senior analyst for digital health at eMarketer, noted that “Wall Street’s reaction is often based on perception.” Steve Sosnick, chief strategist at Interactive Brokers, called the pullback “a bit disappointing” and warned that “that’s usually not a good sign.” 4
The FDA and Novo news come shortly after Hims expanded its Labs services this week. On Feb. 4, the company rolled out access to a multi-cancer early detection blood test featuring GRAIL’s Galleri, which identifies signals tied to over 50 cancer types. 5
A separate SEC filing revealed that Chief Financial Officer Oluyemi Okupe sold 5,262 shares on Feb. 3, exercising stock options at an average price near $26.44. This transaction took place under a Rule 10b5-1 trading plan established in May 2025. 6
Hims’ bigger near-term threat isn’t its range of products but regulatory and legal challenges. Should the FDA crack down on mass marketing of compounded “copycats,” the company might see stricter restrictions on both sales and promotional claims. On top of that, legal fees could spike if branded drugmakers seek injunctions or sue for damages.
Investors are eyeing any firm FDA decisions, along with upcoming legal steps from Novo and other drugmakers developing oral obesity treatments. Hims will report its fourth-quarter and full-year 2025 results after the market closes on Feb. 23, followed by a 5 p.m. ET conference call. Traders will zero in on updates about the company’s weight-loss strategy and regulatory risks. 7
