Reason for the June 29th slump: The FDA just released new briefing materials for the Peptides meeting on July 23-24.

​Here's a quick summary:

​The FDA proposes excluding all 7 peptides from the 503A bulk drug substance list (keeping them "OFF") — this means 503A compounding pharmacies will be unable to compound BPC-157, TB-500, or other peptides under review.

​This is still a preliminary proposal. The PCAC (Pharmacy Compounding Advisory Committee) will provide recommendations to the FDA at the meeting, and the FDA will make a final decision after considering the PCAC's input.

​The FDA just added 8 new members, most of whom are involved in promoting or prescribing peptides. The committee now effectively has a composition "loaded with interests" that leans towards making favorable recommendations for peptides.

​2. Key Points Summary

​Negative regulatory stance (bearish): The FDA's current preliminary stance is very tough, proposing to exclude all 7 popular peptides like BPC-157 and TB-500 from the 503A list that allows legal compounding. This is a major obstacle for Hims, which wants to sell these products compliantly.

​The game is still uncertain (potential turnaround): This policy is currently only a "preliminary proposal," not a final decision. The PCAC advisory meeting at the end of July will be a critical window, and the backgrounds of the 8 newly added members mostly support the peptide business. This means the internal dynamics of the committee could bring a reversal opportunity for the final compliance fate.$Hims & Hers Health(HIMS.US)