Hims & Hers Health (NYSE:HIMS) shares surged this week, closing 13.7% higher after the U.S. Food and Drug Administration (FDA) announced a high-stakes meeting to re-evaluate the regulatory status of several popular peptides.
The Pharmacy Compounding Advisory Committee is scheduled to meet July 23-24 to determine if seven specific substances—previously restricted due to safety concerns—should be added to the list of substances that compounding pharmacies are permitted to produce.
The review is a significant development for the telehealth giant, which confirmed to investors in February that it intends to enter the peptide market.
Following the news, premarket trading saw the stock climb an additional 9.6%.
The July 23 session will focus on BPC-157, KPV, TB-500, and MOTs-C, while the July 24 session will cover Emideltide, Semax, and Epitalon.
"The FDA's plans to more clearly define the regulatory status of several peptides is an important step toward moving these treatments out of the gray market and into more trusted channels," said Pat Carroll, Chief Medical Officer at Hims & Hers.
The company argues that oversight by vetted healthcare professionals will improve patient safety in a category that has largely operated without traditional pharmacy guardrails.
The regulatory environment for peptides has been fraught since 2023, when the FDA removed 19 peptides from the approved compounding list, citing risks to the liver, kidneys, and heart.
The upcoming July meeting effectively reopens the door for seven of those substances.
Industry advocates, including the Alliance for Pharmacy Compounding, argue that current restrictions have merely driven demand to an unregulated gray market of imported chemicals.