HIMS Stock Gains As FDA Reportedly Moves Toward Lifting Restrictions On Peptides

• In February 2025, Hims & Hers announced the acquisition of a peptide facility in California to meet the growing demand among Americans for personalized healthcare and treatment options.
• An NYT report stated that top leaders at the FDA have reservations about peptides, according to a senior Department of Health and Human Services official.
• On a recent episode of the Joe Rogan podcast, Health and Human Services Secretary Robert F. Kennedy Jr., who oversees the FDA, said he is a “big fan” of peptides.

Hims & Hers Health Inc. (HIMS) shares surged on Tuesday morning amid a report stating that the U.S. Food and Drug Administration is moving to lift restrictions on peptides.

According to a report by The New York Times, the FDA is moving to allow compounding pharmacies to manufacture over a dozen injectable peptides that were previously banned due to potential safety risks.

This decision would reverse a 2023 ban that resulted in the removal of 14 peptides from a list of products that the FDA allowed compounding pharmacies to produce.

Shares of Hims & Hers, which provides compounded medications, surged more than 7% in Tuesday morning’s trade.

Top FDA Leaders Have Reservations About Peptides, Says Report

The report added that top leaders at the FDA have reservations about peptides, according to a senior Department of Health and Human Services official. It noted that if the FDA had flagged peptides as being marketed through unproven claims of disease-fighting and cosmetic benefits.

In its 2023 notification, the regulator listed several bulk drug substances, including peptides, noting that it had identified “potential significant safety risks” associated with them.

RFK Jr. Says He Is A ‘Big Fan’ Of Peptides

During an episode of the Joe Rogan podcast earlier this month, Secretary of Health and Human Services Robert F. Kennedy Jr. said that he is a “big fan” of peptides. As the HHS secretary, RFK Jr. oversees the FDA.

“I’ve used them myself, and used them with really good effect on a couple of injuries,” he said, while adding that during the Biden administration, 19 peptides were “illegally” moved to Category 2 of the Bulk Substances Nominated Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act.

This category prohibits compounding pharmacies from formulating compounds comprising peptides, RFK Jr. added.

“There was huge demand for peptides and a black market came up, and the black market is run by companies that say the peptides are for animal use or research purposes. And that peptide now basically completely replaced the legal market,” he said.

Where Does Hims & Hers Fit In This Case?

Hims & Hers had come under fire from regulators and Novo Nordisk AS (NVO) for offering a compounded version of the company’s best-selling weight-loss pill, Wegovy.

Novo Nordisk subsequently dropped its lawsuit against Hims & Hers and announced a partnership to offer Ozempic and Wegovy at affordable self-pay prices on the telehealth company’s platform.

Earlier in February 2025, Hims & Hers announced the acquisition of a peptide facility based in California to address the growing demand from Americans for personalized healthcare and treatment options.

“The peptide capabilities made possible through this acquisition position the company in the coming years to explore exciting advances in peptide innovation, including across areas of consumer need such as preventive health, metabolic optimization, cognitive performance, recovery science, and biological resistance,” the company said.

What Are Peptides?

Peptides are short chains of amino acids, the same building blocks that make up proteins, linked together by peptide bonds.

Blockbuster weight-loss drugs Ozempic and Wegovy are also peptide medications that use glucagon-like peptide-1 (GLP-1) receptor agonists to treat type 2 diabetes and obesity by stimulating insulin secretion.

HIMS stock is down 39% year-to-date and 33% over the past 12 months. The iShares Core S&P Mid-Cap ETF (IJH) is up 14% over the past 12 months, while the iShares Russell 2000 ETF (IWM) is up 22%.

Also See: Buffett Says He Sold Apple Shares Too Soon, But Does Not Regret It: Report

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