Hims opens a waitlist for peptides
Also in this issue: Its first menu is the one clinics already sell
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Take. Hims & Hers is going after the wellness menu clinics already sell, starting with sermorelin, NAD+ and B12. Expect paid search for those terms to get more expensive once Hims starts bidding. We'd put budget into retention for current patients before Hims names a price.
Hims & Hers CEO Andrew Dudum previewed a new Peptides+ specialty on Thursday, a day after HHS said it doesn't intend to take enforcement action against 503A pharmacies compounding six peptides. In a Hims newsroom post, Dudum called the HHS draft policy "meaningful progress toward a regulated, safer pathway to care." He said Hims built "our very own U.S.-based peptide manufacturing facility." The post doesn't say whether that site is a 503A pharmacy or a 503B outsourcing facility.
Hims plans to offer sermorelin, glutathione, B12, NAD+ and L-carnitine. BPC-157 and TB-500, two of the six peptides in the HHS policy, would follow "when allowable." Independent providers would prescribe. Licensed pharmacies would fill. Hims hasn't posted a price or a launch date. Customers can join a waitlist.
Pharmacies say capacity is the open question. Joshua Fritzler, president of Olympia & Wesley Pharmaceuticals in Central Florida, told NPR he doesn't think small compounders alone can meet demand, since outsourcing facilities aren't covered. He said his own pharmacy needs time to get its facility ready. Dr. Robert Steinbrook of Public Citizen put the risk more bluntly to NPR: "you're just rolling the dice, basically." NCPA, the independent pharmacists' trade group, noted that HHS gave no timeframe for how long the policy lasts.
| When | Who | Side | Status |
|---|---|---|---|
| Fri., Oct. 30 | HHS | Peptide notice publishes | Scheduled |
| Mon., Nov. 9 | Hims & Hers | Q3 results | Watch for a Peptides+ price or date |
| About Fri., Nov. 13 | Public | Comments on docket HHS-OASH-2026-0496 | Close two weeks after publication |
Supply
Estrogen shortages spread past the patch
Some estradiol injections and vaginal creams are short too, Reuters reported Wednesday. ASHP, the hospital pharmacists' group that tracks shortages, listed estradiol injections from Hikma, American Regent and Par Sterile Products in shortage in early September. It lists vaginal estradiol creams from Mylan, Padagis and Teva on backorder or allocation. CVS Health told Reuters the injection shortage has worsened in recent weeks. Midi Health chief medical officer Kathleen Jordan described "a domino effect" as prescribers move patients from patches to gels and creams. FDA said in September that patch supply had nearly doubled in a year but still trailed demand.
Expect women's HRT clinics to spend more staff hours chasing estradiol stock in every form. We'd line up a backup pharmacy for each form a clinic prescribes.
The Signal
Prescriber
FDA delays its estrogen-androgen cutoff to May 2027
FDA's Drug Efficacy Study Implementation program, known as DESI, reviews older drugs that reached the market before modern effectiveness rules. In May, FDA concluded that estrogen-androgen combination tablets such as Syntest D.S. and H.S. lack substantial evidence of effectiveness for menopausal hot flashes in patients not helped by estrogen alone. Selling one across state lines without an approved application was set to become unlawful. FDA has pushed that date back a third time, from next Wednesday to May 4, 2027, in a Federal Register notice that publishes Friday. FDA says it needs time "to consider issues raised by interested parties." The efficacy finding stands. The notice covers approved-application products and says nothing about compounded versions. Prescribers who use these tablets get six more months to plan a switch.
Everyone
Lilly sold more GLP-1s at lower prices
Lilly's US revenue rose 34% to $15 billion in the third quarter, the company reported Thursday. US volume rose 41%. Realized prices fell 7%, mostly on Zepbound. Zepbound brought in $5 billion worldwide, above the $5 billion analysts expected, according to StreetAccount data cited by CNBC. Lilly raised its 2026 revenue forecast to $91 billion to $92 billion. Expect more patients to price-check a clinic's compounded tirzepatide against LillyDirect.
Patient Demand
Lilly says four in 10 new oral GLP-1 patients pick Foundayo
Lilly's CFO said about four in 10 patients starting an oral obesity drug choose Foundayo, CNBC reported. Its $184 million in Q3 sales missed estimates.
Wire
- DEA's final rule on a special telehealth registration for controlled substances went to OIRA, the White House regulatory office, in August. OIRA has more stakeholder meetings set for November, Frier Levitt reported Tuesday.
- Sibannac, an OTC-traded plant-medicine company, took a 51% stake in Apollo Wellness Centers, a venture with telehealth platform Doc-Rx. Apollo plans prescriber-owned clinics under a brand license, per its release.
- Dates we're watching:
- The peptide notice and the DESI extension publish Friday, Oct. 30.
- Hims & Hers posts Q3 results Monday, Nov. 9.
- Peptide comments close about Friday, Nov. 13.
- DEA telehealth flexibilities expire at the end of the year.
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Optimized Daily Report is business news for clinic operators. Not medical, legal, or investment advice. Company claims are the company's.