Hims & Hers Health may be on the verge of entering what analysts believe could be a multi-billion-dollar market — if federal regulators decide to ease restrictions on a class of drugs known as peptides.
The telehealth company, best known for offering personalized treatments for conditions like hair loss and acne, has been eyeing peptides as a new frontier. This comes shortly after the company’s efforts to produce compounded versions of popular weight-loss drugs were shut down by federal regulators. Peptides — which are used for purposes ranging from pain relief and muscle recovery to cosmetic treatments — have gained attention through social media influencers and Health and Human Services Secretary Robert F. Kennedy Jr.
A U.S. Food and Drug Administration advisory committee is convening this week to consider whether compounding restrictions on seven peptides should be relaxed. Research firm Needham & Co. estimates the potential market could reach $3.3 billion, while Leerink analyst Michael Cherny puts the figure at $2.2 billion.
Whether peptides become more widely available largely depends on the FDA’s decision. Because Kennedy has publicly stated he has personally used peptides, some analysts believe approval is likely no matter how the committee votes.
If restrictions are eased, a former FDA official — who asked not to be named — said it could take up to a year for the rulemaking process to allow compounders to begin producing the products for patients.
Hims & Hers announced its interest in peptide therapies in 2025, acquiring a manufacturing facility capable of producing them. CEO Andrew Dudum has said the treatments are expected to grow in demand as more consumers focus on preventative health care.
Peptide treatments are drugs made from short chains of amino acids — the same basic components the body relies on to build proteins.
The exact timeline for any product launch remains unclear. In April, Dudum said the company did not feel pressure to be the first in the U.S. to bring peptides to market.
“If guidance changes, our clinical and compliance teams will assess what that means for our platform, and we will adjust accordingly,” a Hims spokesperson said.
Hims & Hers operates one of the country’s most widely used compounding pharmacy businesses, which create customized treatments by blending ingredients for individual patients. The company’s stock has a reputation for sharp swings — both dramatic gains and steep losses. Over the past five months, the stock has more than doubled, partly driven by a new partnership with Danish pharmaceutical company Novo Nordisk.
Unlike brand-name drugs, compounded products are not reviewed by the FDA for quality or effectiveness. State governments also hold regulatory authority over compounding operations.
Analysts, legal professionals, and investors broadly expect the advisory committee to recommend loosening compounding rules, citing Kennedy’s backing and the presence of industry-aligned members on the panel — even after FDA staff raised concerns in June about the evidence supporting peptide compounding.
The 14-member committee reviewing peptides has added seven individuals who work for or operate clinics and businesses that already sell peptide treatments.
Attorney Bill Holtz of Foley & Lardner said Kennedy’s position is likely to carry more influence in the peptide review than has been typical under previous administrations. “The law gives the Secretary of Health and Human Services the authority to determine what goes on that list,” Holtz said.
A spokesperson for HHS did not respond to a request for comment.
The Alliance for Pharmacy Compounding, a trade group, urged the FDA this month to permit peptide compounding under regulatory oversight. Kennedy, who has acknowledged using peptides himself, described in April a black market of unregulated peptide products still entering the United States.
PhRMA, the pharmaceutical industry’s main trade organization, submitted written comments to the FDA arguing against allowing peptide compounding under Section 503A of the Federal Food, Drug, and Cosmetic Act, the provision that permits such combinations.
Ignacio Canto, founder of X-Square Capital — which holds less than 1% of Hims & Hers — said he expects the company to move quickly to launch peptide products if it receives regulatory clearance.
Options traders are also anticipating increased volatility in Hims stock in the coming weeks. Data from Trade Alert shows shares could move as much as 14% in either direction before the end of the month.
