HIMS Stock Snaps 3-Day Losing Streak: FDA Adds 8 New Peptide Voters Deemed ‘More Qualified And Less Conflicted’

• The FDA added eight temporary voting members to its Pharmacy Compounding Advisory Committee ahead of the peptides meeting.
• Former FDA official Peter Lurie called the additions “considerably more qualified and less conflicted.”
• Peptide advocates are seeking a fair review as the meeting revisits 2023 restrictions.

Shares of Hims & Hers Health, Inc. (HIMS) stock rebounded on Tuesday after the FDA expanded its peptide advisory panel with eight new voting members ahead of a crucial review of seven unapproved compounds.

HIMS stock rose a modest 0.1% on Tuesday, with shares headed for their worst month since February. 

FDA Adds 8 Peptide Panel Voters 

The FDA added the members to its Pharmacy Compounding Advisory Committee shortly before the panel’s July Thursday-to-Friday meeting, after criticism over the commercial ties of some previously appointed participants. The new temporary voters are Todd Durham, Costantino Iadecola, Brian P. Lee, Josh Mailman, Friedhelm Sandbrink, Maral Kibarian Skelsey, Kevin L. Zacharoff and William C. Zamboni.

Their backgrounds span clinical research, neurology, gastroenterology, pain management, addiction, dermatology, cancer pharmacology and patient advocacy. Several will participate only in discussions involving peptides tied to their specialties.

Iadecola and Sandbrink, for example, are restricted to the Semax review. Lee will vote only on BPC-157, while Skelsey’s participation is limited to KPV and TB-500. Zacharoff will consider only Emideltide.

Peter Lurie, a former FDA associate commissioner and current president of the Center for Science in the Public Interest, said the additions appeared to improve the panel’s credibility. “They seem considerably more qualified and less conflicted than the others who were added recently,” Lurie said. “The new members are mostly confined to certain peptides, not the case for the earlier nominees,” according to a Bloomberg report.

Peptides Face Regulatory Test

The committee will evaluate BPC-157, KPV, TB-500, MOTS-c, Emideltide, Semax and Epitalon for possible inclusion on the Section 503A Bulks List. Inclusion could give certain licensed pharmacies a clearer legal route to compound the substances for individual patients.

The peptides are marketed for uses including inflammation, wound healing, obesity, sleep, cognitive performance and healthy aging. None has been approved by the FDA for the proposed compounded uses. FDA staff have recommended against adding the seven substances, pointing to limited human evidence, uncertain formulations and unresolved concerns involving immune responses, contamination and product quality.

Peptide Advocates Push For Fair Review 

Peptide advocates hope the expanded panel will deliver a more balanced review. “I remain hopeful that the process will be fair and free of conflicts, and that recommendations will be formed based on the merits,” said Lee Rosebush, chairman of the American Academy of Peptide Medicine.

The meeting could reopen restrictions imposed in 2023, when regulators determined that nearly 20 peptides posed safety concerns and should no longer be legally compounded. The FDA staff’s cautious stance also contrasts with Health Secretary Robert F. Kennedy Jr.’s more permissive view of peptides. Kennedy has publicly discussed using them for injuries, while 12 other substances were moved into Category 1 in April.

How Do Retail Traders Feel About HIMS?

On Stocktwits, retail sentiment for HIMS was ‘bearish’ amid a 47% jump in 24-hour message volumes.

One user said, “$HIMS  I sold half my shares of HIMS today and bought GRRR with the proceeds.  I feel there is too much risk with this week's FDA committee and upcoming quarterly earnings. Still bullish, though.”

Another user noted, “$HIMS look at options flow - puts being printed- absolutely selling off this week and next for sure”

HIMS stock has declined 31% over the past year. 

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