Hims & Hers just lived through the worst week in its history. What started as regulatory scrutiny escalated into a three-front war: federal agencies threatening criminal prosecution, the FDA announcing a crackdown, and now Big Pharma's largest player suing for patent infringement.
The stock tells the story: down 75% from its 52-week high of $68.74 to $17.24. Eight consecutive red days. A 25% single-day crash on Monday. This isn't a dip — it's capitulation.
Here's how Hims went from GLP-1 disruptor darling to regulatory pariah in seven days.
The Timeline of Destruction
| Date | Event | Impact |
|---|---|---|
| Feb 5 | Hims launches $49/month compounded semaglutide pill | Stock initially up on the news |
| Feb 6 | FDA announces intent to restrict GLP-1 compounding ingredients | Stock drops 14% |
| Feb 6 | HHS refers Hims to DOJ for potential criminal violations | Fear escalates |
| Feb 7 | Hims pulls the $49 pill after 48 hours | Retreat mode |
| Feb 9 | Novo Nordisk files patent lawsuit (US Patent 8,129,343) | Stock crashes 25% |
| Feb 10-11 | Continued selling, down 10%+ more | Now trading at $17.24 |
Three separate attacks. Three different vectors. Zero good options.
The Novo Nordisk Lawsuit: The Kill Shot
The most significant new development: Novo Nordisk filed its first U.S. patent infringement lawsuit against a compounder over Wegovy on February 9.
The lawsuit targets Hims directly for infringing U.S. Patent 8,129,343 — which protects semaglutide through 2032. Novo is seeking:
- Permanent injunction banning Hims from selling ANY compounded semaglutide products
- Monetary damages for past and ongoing sales
John Kuckelman, Novo's General Counsel:
"This is a complete sham, and it has been a sham since the shortage ended. Their medicines are untested, and they're putting patients at risk."
Why now? The FDA determined semaglutide is no longer in short supply — eliminating the regulatory loophole that allowed compounding in the first place. With shortages resolved, Novo faces no PR backlash for enforcing its patents.
The legal argument: Hims claims its products are "personalized" by dosage, making them legal under compounding rules. Novo calls this "mass compounding" dressed up as personalized medicine.
Kuckelman: "You're producing mass stocks of what you're calling a personalized medicine, which is really just a dosage variation."
This isn't Novo's first rodeo. They've filed ~130 lawsuits against compounders for deceptive marketing and consumer fraud. But this is the first patent infringement suit — signaling they're done playing whack-a-mole and going for the jugular.
The DOJ Referral: Criminal Exposure
On February 6, HHS General Counsel Mike Stuart referred Hims to the Department of Justice for potential violations of:
- Federal Food, Drug, and Cosmetic Act — selling unapproved and misbranded drugs
- Federal criminal statutes — mail/wire fraud, conspiracy
This escalates beyond regulatory fines into potential criminal territory. If willful intent is proven, executives could face prison time (1-3 years) and the company could face felony charges.
The backstory: In September 2025, the FDA issued warning letters to Hims (and 100+ other telehealth firms) for "unlawful sale of unapproved and misbranded drugs." Hims apparently didn't get the message.
DOJ process: Historically, DOJ accepts only 20-30% of FCA referrals. But given the Trump administration's emphasis on pharmaceutical accountability and $5.7 billion in FY 2025 healthcare FCA recoveries, this could move fast.
The FDA Crackdown: Closing the Loophole
FDA Commissioner Martin Makary didn't mince words on February 6:
"FDA intends to take action against non-FDA-approved GLP-1 drugs."
The agency announced plans to:
- Restrict active pharmaceutical ingredients (APIs) used for GLP-1 compounding
- Refer violators to DOJ for prosecution
- Name Hims explicitly as a mass-marketer abusing the compounding exemption
With semaglutide no longer in shortage, the legal basis for compounding evaporates. The $49 pill that was supposed to be Hims' 2026 growth engine? Dead on arrival.
The Numbers: A Disaster
Let's quantify the destruction:
| Metric | Before | After | Change |
|---|---|---|---|
| Stock Price (52-week high) | $68.74 | $17.24 | -75% |
| Market Cap | ~$14B | ~$3.5B | -75% |
| Week-over-week | $25+ | $17.24 | -30%+ |
GLP-1 weight-loss drugs represented a massive growth opportunity for Hims — estimated at 10-20% of forward revenue projections by some analysts. That's now a question mark at best, a liability at worst.
Hims' Response: Defiant but Cornered
Hims isn't going quietly. Their official statement on the Novo lawsuit:
"This is a blatant attack by a Danish company on millions of Americans who rely on compounded medications for access to personalized care. Big Pharma is weaponizing the US judicial system to limit consumer choice."
The company claims a "long history of providing safe access to personalized healthcare."
The @himshouse investor community on X echoed the defiance, calling Novo's suit an "own goal" that will ultimately fail. But defiance doesn't win lawsuits, and the stock's collapse suggests the market isn't buying the bravado.
What's Left of the Bull Case?
It's not all doom. Hims has other revenue streams:
- ED treatments — still the core business
- Hair loss — growing category
- Dermatology — expanding
- Mental health — newer but promising
- Cancer diagnostics — just launched Galleri test at 74% discount
The GLP-1 business, while high-profile, wasn't the majority of revenue. The question is whether the regulatory heat spills over into the core telehealth model.
Risk: The FTC has been investigating Hims since August 2025 over advertising practices and subscription cancellation complaints. If the DOJ probe uncovers broader issues, the whole business could face scrutiny.
What to Watch
- DOJ decision — Do they accept the referral? Subpoenas would signal escalation
- Novo preliminary injunction — Could halt all semaglutide sales within weeks
- Q4 earnings — What does guidance look like without GLP-1?
- Settlement signals — Most similar cases resolve with fines and consent decrees
- Insider activity — Any executives buying or selling?
The Bottom Line
Hims bet big on being the low-cost GLP-1 disruptor. That bet has blown up spectacularly.
The company now faces:
- A patent lawsuit that could ban its entire semaglutide business
- A DOJ referral that could result in criminal charges
- An FDA that has explicitly named it as a target
- A stock down 75% from highs with zero visibility on when the bleeding stops
Some investors see a contrarian opportunity. The core telehealth business is profitable. The stock is cheap on a P/E basis if you strip out GLP-1 expectations.
But "buy the dip" requires knowing where the dip ends. Right now, nobody knows — including Hims.
Hims & Hers Health (NYSE: HIMS) closed at $17.24 on February 10, 2026, down 75% from its 52-week high. Novo Nordisk (NYSE: NVO) rose 3% on news of the lawsuit.
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