Hims & Hers Stock Rises on FDA Peptide Review News
Shares of telehealth company Hims & Hers Health (HIMS) rose for a second consecutive day following an announcement by U.S. Health and Human Services Secretary Robert F. Kennedy Jr. regarding a regulatory review of certain peptides.
Stock Movement and FDA Announcement
Hims & Hers stock increased by approximately 6% in early trading on Thursday, June 27, 2024. This followed a 13% increase on Wednesday, June 26.
Despite the recent gains, the company's stock has declined by approximately 23% year-to-date.
The stock movement is reported to be linked to Secretary Kennedy's announcement. In a post on social media platform X, Kennedy stated that the FDA will remove seven peptides from "Category 2" for evaluation. Category 2 is a designation for drugs the FDA considers potentially too dangerous or insufficiently proven for compounding pharmacy production.
Regulatory Review Process
The peptides will be reviewed by the Pharmacy Compounding Advisory Committee (PCAC) at its next two meetings, beginning in July. According to Secretary Kennedy, independent experts will evaluate each substance based on scientific merits using clinical, pharmacological, and safety evidence.
Kennedy stated that this action "begins to restore regulated access and will immediately begin shifting demand away from the black market."
The July meeting is advisory, and any regulatory changes are not expected to be immediate.
Company Context and Background
Hims & Hers has been developing a peptide business for several years. In February 2025, the company acquired a peptide manufacturing facility in California to expand treatments for areas such as weight loss and muscle recovery.
The company's stock has been affected by regulatory concerns over compounded versions of GLP-1 weight-loss drugs. In a related development from March 2024, drug manufacturer Novo Nordisk withdrew a patent infringement lawsuit against Hims & Hers. The two companies later announced a collaboration to provide GLP-1 customers access to FDA-approved medications and, on a limited scale, compounded semaglutide.
Statements and Analyst Commentary
Following the FDA announcement, Hims & Hers Chief Medical Officer Dr. Patrick Carroll stated the move could bring peptide therapy into regulated, physician-led care and away from a "gray market."
He said the company's medical team believes certain peptide therapies hold potential and that they are exploring how to expand access in alignment with FDA guidance.
Leerink Partners analyst Michael Cherny noted the FDA review could provide a clearer regulatory path for Hims & Hers to scale peptide therapies but said it would not immediately translate into revenue. Cherny has a hold-equivalent rating on the stock with a $25 price target. The stock traded around $26 per share on Thursday.
Background on Peptides
Peptides are short chains of amino acids being explored for various health and wellness uses. Scientific evidence regarding the long-term safety and effectiveness of many peptide therapies is described as limited, and their production remains largely unregulated.
Of the peptides listed for consideration, one—MK-677—is often treated as an illegal drug when sold for human consumption and is banned by the World Anti-Doping Agency. Others, such as GHK-Cu and Semax, are generally viewed as less controversial but also lack robust scientific backing.
Additional Congressional Testimony
During a House Ways and Means Committee hearing on Thursday, Secretary Kennedy was asked about expanding peptide therapies.
He stated, "Peptides were not supposed to be regulated," and argued that the Biden administration restricted their use due to safety concerns he considers unfounded.