Hims & Hers Stock Jumps as FDA Panel Opens the Door to a Multibillion-Dollar Peptide Market

Hims & Hers Health (HIMS) shares climbed roughly 10% Thursday after an FDA advisory committee voted to place the popular peptide BPC-157 on the compounding list — a decision that could hand the telehealth company an early lead in a market analysts value in the billions.

What the FDA Panel Decided

This week, the FDA’s compounding advisory committee met to weigh whether the agency should loosen restrictions on seven peptides. Rather than slam the door, the panel began backing wider access — and specifically voted to add BPC-157, a peptide used for pain and muscle recovery. Investors reacted immediately, sending HIMS sharply higher on the news.

Why the Market Is So Large

The stakes help explain the enthusiasm. If regulators ease compounding rules, Needham & Co. estimates the peptide market could reach as much as $3.3 billion, while Leerink analyst Michael Cherny pegs it closer to $2.2 billion. Peptides already draw demand across pain management, muscle recovery, and beauty, and social-media influencers — along with HHS Secretary Robert F. Kennedy Jr. — have amplified their popularity.

How Hims & Hers Is Positioned

Crucially, Hims prepared for this moment well in advance. The company first announced its peptide ambitions in 2025 and bought a manufacturing facility capable of producing them. Because it already runs one of the largest compounding pharmacy businesses, Hims can move quickly if the FDA formalizes looser rules. As CEO Andrew Dudum framed it, demand for these treatments should grow as consumers lean further into preventative health — though he added the company doesn’t need to be first to market.

The Regulatory Road Ahead

Even so, approval won’t translate into products overnight. A former FDA official cautioned that formal rulemaking to let compounders make the products could take up to a year. Moreover, compounded treatments don’t undergo the FDA’s quality and efficacy review that branded drugs face, and individual states retain authority over compounding. Consequently, timing remains uncertain even in a favorable scenario.

Why Analysts Still Expect a Green Light

Despite pushback from FDA staff in June and opposition from industry group PhRMA, many analysts expect the committee to keep favoring looser rules. They point to Kennedy’s vocal support for peptides and note that the review committee added members who work in the peptide business. As one legal expert put it, the HHS Secretary’s view is likely to carry unusual weight in this process.

The Bottom Line

Ultimately, Thursday’s vote gives Hims & Hers a fresh growth narrative just months after regulators blocked its compounded weight-loss ambitions. The stock remains notoriously volatile — options traders are bracing for swings of up to 14% by month’s end — but if the FDA follows through, Hims could convert its head start into a meaningful new revenue stream. For now, investors are betting it will.