The FDA will meet in late July to discuss moving a large group of peptides to the "compounding" class. HIMS, LFMD, BANB.

First off this is NOT financial advice. I hold no major positions in any of the names mentioned. DD.

Been involved with the peptide space for a while. First off, under Section 503A of the FD&C Act, compounding pharmacies can only legally make a drug from a bulk substance if it's on the FDA's approved list. For peptides that list is currently extremely small, I think maybe 5 or 6 total. Sermorelin, glutathione, NAD+ (not even a peptide), and a handful of others for specific medical conditions.

On July 23 and24, the FDA's advisory committee will vote on adding seven peptides to that list: BPC-157, KPV, TB-500, MOTS-c, DSIP, Semax, and Epitalon. Five more are scheduled for a second meeting before February 2027. If a peptide is added to this list, it means that licensed compounding pharmacies can legally prepare them for patients with a prescription. This is a much lower bar that the current regulations around peptides.

History on this: 2024, the committee voted AGAINST including six peptides across two separate meetings. So then yea then the upcoming meeting doesnt seem promising. Except there was an admin change and as we know that impacts the market quite a bit. The political attitude on peptides and the general view on the "biohacking" space has changed a lot. RFK Jr. went on Joe Rogan in February and he announced plans to move roughly 14 peptides back to Category 1. Two months later the FDA removed 12 of those 14 peptides from Category 2 in April and scheduled this hearing.

back to the admin change point, the committee itself has changed. Several prior members were removed in 2025 and haven't been replaced. There have been repeated efforts by Trump to control the FDA, i.e. by removing Marty Makary from FDA Commissioner just a month ago. So I think it is fair to say that the admin wants to make sure that the FDA does their bidding and helps to further the "MAHA" movement. The PCAC currently has four members, down from thirteen in 2024, and I would bet that those four are very well aligned with the admin and the goals of RFK.

The specific peptides being reviewed for the July docket are also pretty clean safety wise. BPC-157's nomination is specifically for ulcerative colitis, where there is a Phase 1 GI trial history. KPV has published anti-inflammatory mechanism data. These peptides dont have overwhelmingly strong evidence but its a lot better than the peptides in 2024.

I'd put the odds of a positive recommendation for at least some ( call it 3 or 4 out of 7) of the July batch at about 80%. Not certain but far more likely than in previous review sessions.

Now if the committee recommends all seven, compounding pharmacies still can't TECHNICALLY act until the FDA completes formal notice-and-comment rulemaking. That can take 12-18 months.

But in the past the FDA has signalled enforcement discretion when peptides have been moved to 503A. This means it won't take action against pharmacies compounding these substances while rulemaking proceeds. In the past, this allowed GLP-1 compounding during the semaglutide shortage. There is no long process for this, it is a policy statement the FDA can issue within weeks of the hearing.

Based on the political setup (RFK's public commitment, the administration's stated MAHA agenda, congressional letters from Harshbarger and Tuberville specifically naming BPC-157), I think enforcement discretion for at least KPV, BPC-157, and Semax within 60-90 days of a positive vote is plausible, call it 70%, obviously conditional on the vote going well. TB-500 and others are slightly more complex given manufacturing risk profiles, but could still happen.

Now to the part you all legit care about

Hims & Hers (HIMS)

HIMS built a massive compounded GLP-1 business in 2024-2025, and then took a direct hit when the FDA ended the semaglutide shortage. $33.5M in restructuring charges in Q1 2026 , Q1 revenue of $608M missed the $617M consensus, and GAAP net loss widened to $92M. The March deal with Novo Nordisk ended the GLP-1 compounding business for them.

But as some may know, HIMS acquired a U.S. peptide manufacturing facility in 2025 and it maintains over one million square feet of 503A compounding infra. A lot of this capacity is not currently being used. Canaccord estimates the compounded peptide TAM (ex-GLP-1s) at about $20 billion over 3-5 years, and pegs every 1% market share at $200M in incremental HIMS revenue.

Now thhe stock already ran like 50% on the April RFK/FDA announcement. So is it priced in?

Well the April move priced the possibility of peptide access. A July positive vote plus the discussed enforcement discretion signal would price the near-term reality of peptide revenue. I do not believe that the second one is priced in. The risk is that HIMS is navigating a painful GLP-1 transition and Novo Nordisk sued them in February, so its not a clean play.

My move is $35 calls expiring August 21. this is probably aggressive but...

LifeMD (LFMD). A smaller stock , more leveraged to the upside, and under-discussed.

LFMD runs the same telehealth-plus-pharmacy model as HIMS but at a fraction of the size: Q1 2026 revenue of $50.2M, full-year guidance of $220-230M. Market cap is a fraction of HIMS.

The peptide TAM math is more interesting here on a percentage basis. LFMD doesn't own manufacturing, rather it's a prescriber/platform that routes to affiliated pharmacies. That means lower capex to participate, but also lower margin capture and no supply chain moat. If the peptide compounding window opens, LFMD is a fast follower on the distribution side, not a manufacturer.

The stock hasn't had the HIMS-style run on this theme. If you believe the HIMS bull case but think it's partially priced, LFMD offers a leveraged version of the same narrative at a lower starting point.

Q1 was strong. 42,000 net telehealth subscriber adds, largest quarterly net addition in company history, 88% gross margin.

I think this has potential to double by September.

Bachem (SIX: BANB).

Bachem is a Swiss peptide manufacturer. They make the raw pharmaceutical-grade peptide inputs that compounding pharmacies need to produce these drugs. Revenue \~CHF 695M in 2025. Listed on the Swiss exchange (SIX: BANB), accessible via OTC in the U.S.

Multiple legal sources have flagged that if the FDA opens enforcement discretion, API supply availability will become the binding constraint on how fast compounding pharmacies can actually scale. Pharmaceutical-grade BPC-157 or TB-500 synthesized to USP standards takes specialized capacity. You can not just redirect Chinese research-chemical supply chains into a 503A pharmacy. The purity, sterility, and characterization requirements are completely different.

Bachem is the global leader in peptide contract manufacturing. If the compounding market opens up, they're the picks-and-shovels play. They benefit regardless of which telehealth platform wins the consumer relationship.

The risk is that Bachem is a CHF-denominated large-cap with diverse revenue, so the U.S. peptide compounding decision is a meaningful but not dominant catalyst. It won't double on a positive PCAC vote. But it also doesn't carry the GLP-1 restructuring overhang that HIMS does.

TL;DR

The July 23-24 FDA PCAC hearing on 7 peptides is big for HIMS, LFMD, and Bachem. The April RFK announcement priced the possibility of access. A positive vote plus enforcement discretion signal prices the near-term reality. HIMS is the high-conviction, partially-priced play; LFMD is a leveraged, under-discussed version of the same trade; Bachem is the cleanest picks-and-shovels angle.

Read the entire breakdown at my blog: https://peptideprices.net/blog/fda-peptide-hearing-july-2026