HIMS Stock Kicks Off September In The Red: FDA’s GLP-1 Alert Steals The Spotlight From Australia Expansion

• The FDA also flagged dosing errors, contamination, poor refrigeration, fraudulent labels and questionable ingredients.
• Hims launched across Australia by rebranding Pilot and expanding care-team access to 24 hours a day.
• Hims now mainly offers approved Ozempic and Wegovy products under its March agreement with Novo Nordisk.

Shares of Hims & Hers Health (HIMS) began September in the red as a Food and Drug Administration (FDA) warning about unapproved GLP-1 weight-loss drugs overshadowed the telehealth company’s expansion into Australia.

HIMS stock fell 4% on Tuesday to end the session at $28.44.

FDA Warns On Compounded GLP-1 Drugs

The FDA said on Tuesday that unapproved GLP-1 drugs do not undergo its review for safety, effectiveness or quality and should be used only when a patient’s needs cannot be met by an approved treatment.

As of May 31, the agency had received 990 adverse-event reports involving compounded Semaglutide and more than 730 related to compounded Tirzepatide. It cautioned that the total may be underreported since most state-licensed pharmacies are not required to submit such reports.

The FDA also flagged dosing errors that sometimes required hospitalization, contamination risks from multidose vials used beyond 28 days, inadequate refrigeration, fraudulent labels and semaglutide salt forms without a known lawful basis for compounding. It also established an import “green list” to keep GLP-1 ingredients with potential quality concerns out of the U.S. supply chain while allowing shipments from compliant manufacturers.

Hims Pivots To Approved Novo Drugs

Under a March agreement with Novo, Hims mainly offers FDA-approved Ozempic injections and Wegovy injections and tablets. It stopped advertising compounded GLP-1s, reserving them for patients whose clinicians document a specific medical need that approved products cannot meet.

The deal followed Hims’ short-lived February launch of compounded oral Semaglutide starting at $49 per month. Hims withdrew the pill after about two days, citing “constructive conversations with stakeholders across the industry.”

Novo subsequently sued Hims for patent infringement, calling the launch a “tipping point,” but dismissed the case after the companies reached their distribution agreement. 

The branded-drug pivot has pressured profitability. Hims’ Q2 gross margin fell to about 64% from 76% a year earlier because approved GLP-1s cost more than compounded copies. The company reported $753 million in revenue and an $86 million net loss, including restructuring expenses and legal accruals. Hims nevertheless raised its 2026 revenue forecast to between $3.1 billion and $3.3 billion. Nearly all new weight-loss customers have joined through branded products since March.

Hims Launches Across Australia

Hims officially launched its men’s health brand across Australia on Monday, rebranding Pilot after acquiring digital-health company Eucalyptus. Existing Pilot patients will retain their treatment plans, local providers and care relationships while gaining access to Hims’ wider platform. The service covers sexual health, weight loss and hair loss, with care-team access expanding from 12 hours per day to 24/7.

Tim Doyle, Hims’ senior vice president of international and an Eucalyptus co-founder, said attitudes toward men’s health have changed significantly since Pilot launched seven years ago. “Men care more, expect more and understand that the investments they make in their health pay off in how they feel, how they look and how they perform,” Doyle said on X.

How Do Retail Traders Feel About HIMS?

On Stocktwits, retail sentiment for HIMS was ‘neutral’ amid a 20% decline in 24-hour message volumes.

One user said, “$HIMS all this negative news about crackdowns and compliance are just growing pains.” They added: “They literally just expanded into the Asian pacific market…a market that holds the majority of humans in the world. It’ll always be 2 steps fwd one back just gotta remember that”

Another user said, “$HIMS only down 500, might sell and wait. Too much bad news”

HIMS stock has declined 33% over the past year. 

For updates and corrections, email newsroom[at]stocktwits[dot]com.<