FDA本周审议放松七类肽类药物复方限制，Hims & Hers或受益但尚未落地

Hims & Hers Health (HIMS.N) is set to tap what analysts estimate could be ​a multi-billion-dollar market for peptides if U.S. regulators loosen manufacturing restrictions.

Hims, primarily known for its personalized treatments of conditions ranging from hair loss to ‌acne, is eyeing peptides not long after its attempts to create compounds of popular weight-loss drugs were smacked down by U.S. regulators. Peptides — used for everything from pain to muscle recovery to beauty — have been promoted by social media influencers and Health and Human Services Secretary Robert F. Kennedy Jr.

A U.S. Food and Drug Administration advisory committee meets this week to discuss whether the regulator should loosen ​compounding restrictions on seven peptides. If the restrictions are eased, research firm Needham & Co estimates the market could be as big as $3.3 billion, while Leerink analyst ​Michael Cherny estimated the market at $2.2 billion.

Peptides' wider use hinges on the FDA. Because Kennedy has said he has used them, ⁠some analysts say approval is likely regardless of the committee's decision.

If that happens, rulemaking that would allow compounders to make the products for patients could take up to ​a year, according to a former FDA official who requested anonymity.

Hims & Hers first announced it would pursue peptide therapies in 2025, when it purchased a manufacturing facility that ​can produce them. CEO Andrew Dudum has said the treatments would grow in popularity as demand for preventative health increases.

Peptide treatments are drugs built from short chains of amino acids, the same building blocks the body uses to make proteins.

Timing for the launch is uncertain. Dudum said in April that the company would not need to be the first U.S. company to offer peptides.

"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 owns one of the most ​popular compounding pharmacy businesses, which mix ingredients to create personalized treatments for patients. Its stock is notoriously volatile, with dramatic surges and equally staggering selloffs.

Over the last five months, the stock has ‌more than ⁠doubled, in part because the telehealth company entered into a partnership with Danish drugmaker Novo Nordisk (NOVOb.CO).

Compounded products are not reviewed for quality or efficacy by the FDA, unlike branded drugs. States also have authority over compounding.

ANALYSTS EXPECT FDA APPROVAL

Analysts, legal experts and investors said they expect the committee to vote for looser regulations on compounding given the support from Kennedy and other industry-aligned members, even as FDA staffers in June challenged the evidence for peptide compounding.

The 14-member committee reviewing peptides has added seven people who operate or ​work for clinics or businesses selling peptide ​treatments.

Bill Holtz, a lawyer at Foley & Lardner, ⁠said Kennedy’s view will likely hold more weight in the review process for peptides than is typical for the agency under prior administrations.

“The law gives the Secretary of Health and Human Services the authority to determine what goes on that list," said ​Holtz.

A spokesperson for HHS did not respond to a Reuters request for comment.

The Alliance for Pharmacy Compounding, a trade organization, ​urged the FDA this month ⁠to allow compounding with regulatory oversight.

Kennedy, who has said he has used peptides, in April described a black market of unregulated products that still make their way into the United States.

PhRMA, the pharmaceutical industry trade organization, said in written comments to the FDA that the agency should not allow peptide compounding under Section 503A of the Federal Food, Drug, and ⁠Cosmetic Act, ​which allows for such combinations.

Ignacio Canto, founder of X-Square Capital, which owns less than 1% of Hims & ​Hers, said he expects Hims to launch the products quickly if it gets the go-ahead.

Options traders expect more volatility in Hims stock in coming weeks, with Trade Alert data showing shares could swing by as ​much as 14% in either direction by the end of the month.