Hims stock price reacts strongly to crucial FDA review

Hims & Hers (HIMS) has caught a powerful new tailwind, and the market is treating peptides as more than a short-lived headline. The immediate catalyst was the FDA’s decision to hold a July 23-24 meeting of its Pharmacy Compounding Advisory Committee to review whether several peptides should be considered for broader compounding access.

The agency’s agenda includes BPC-157, KPV, TB-500, MOTS-c, emideltide, Semax, and Epitalon. Reuters said the FDA’s move helped send Hims shares higher as investors started pricing in a potential long-term opening for the category.

Reuters reported on April 16 that Hims shares rose more than 7% after the FDA development, while other market coverage showed the rally building over several sessions as investors connected the regulatory review to Hims’ existing peptide ambitions.

The setup gave traders a fresh growth narrative at a moment when the company’s weight-loss business is already being reworked around a broader mix of approved treatments.

Hims had already been building toward peptides

In February 2025, Hims announced that it had acquired a California-based peptide facility, saying the deal would strengthen the long-term durability of its domestic supply chain and support personalized medications.

The company also said the facility would help it explore peptide innovation across preventive health, metabolic optimization, cognitive performance, recovery science, and biological resistance.

Hims already has infrastructure tied to peptides, and the FDA review puts a formal regulatory date on a business line the company had been preparing for well before this month’s rally. The market is now treating that preparation as an asset.

HIMS stock has surged higher over 50% in the last 2 weeks

Cheng Xin via Getty Images

The GLP-1 reset left room for a new growth story

The peptide angle is arriving at an important time for Hims. In March, the company announced a strategic shift in its U.S. weight-loss business, saying it would align more closely with Novo Nordisk and expand access to FDA-approved GLP-1 medications while offering compounded semaglutide only on a limited scale. A few weeks later, Hims said Novo’s FDA-approved GLP-1s were available through its platform.

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Compounded GLP-1s had been a major part of the company’s recent momentum, but moving toward branded treatments raised new questions about future margin drivers and what category could carry the next leg of growth. Peptides now look like the clearest answer investors have found so far.

The core business was already growing fast

The market also has a strong set of company numbers underneath the peptide enthusiasm. In fourth-quarter and full-year 2025 results, Hims reported fourth-quarter revenue of $617.8 million, up 28% year over year, and full-year revenue of $2.35 billion, up 59%.

The company reported 2.51 million subscribers at year-end, up 13%, along with $128.4 million in net income and $318.0 million in adjusted EBITDA for the full year. Hims guided for 2026 revenue of $2.7 billion to $2.9 billion and adjusted EBITDA of $300 million to $375 million.

The company has also kept widening the platform. In February, Hims announced an agreement to acquire Eucalyptus, a digital-health company with operations across Australia, the UK, Germany, Japan, and Canada. Management said the deal would help accelerate its effort to become a larger global consumer health platform.

Hims recent revenue

  • Full-year 2025 revenue: $2.35 billion, up 59%
  • Fourth-quarter 2025 revenue: $617.8 million, up 28%
  • Full-year 2025 net income: $128.4 million
  • Full-year 2025 adjusted EBITDA: $318.0 million
  • Subscribers at year-end 2025: 2.51 million, up 13%
  • 2026 revenue guidance: $2.7 billion to $2.9 billion
  • FDA peptide review dates: July 23-24, 2026

The market is trading future optionality

The July FDA meeting is still only a review step, and the committee’s recommendations are not the same as a broad commercial green light. The agency’s own notice lays out a process built around safety, compounding rules, and technical review. The stock is moving on the possibility that the outcome could widen Hims’ future product menu, not on a new revenue stream that already exists today.

That still leaves a meaningful setup for investors. Hims has a fast-growing core business, a peptide facility already in place, a reshaped weight-loss strategy, and a regulatory event that could open another category with strong consumer interest. The rally reflects a market that sees a new lane forming at exactly the moment the company needed one.

Related: Hims & Hers shifts business model after Novo deal

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