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Hims launches injectable TRT, including a compounded shot
Take. The biggest name in telehealth now sells TRT. Expect it to cost more to win each new patient. Hims will be buying ads on the same search terms and social feeds as clinics, which pushes prices up for everyone. Referrals and patients who stay will count for more. The competition could also push clinics to get better. Faster starts, clear prices and better follow-up are where we'd look first.
Hims added three testosterone options to its men's program on Wednesday. There is a compounded injection given under the skin, generic testosterone cypionate given into the muscle, and Kyzatrex, an FDA-approved oral capsule. They join the enclomiphene product Hims already sold. The investor release calls it the company's largest men's health launch to date. Hims doesn't say which pharmacy makes the compounded shot.
Hims' testosterone page listed the compounded shot from $79 a month on Wednesday night. Generic cypionate starts at $159 and Kyzatrex at $179. Every plan also requires a $49 membership, and the page says the membership doesn't include medication.
Men start with a Tasso kit that collects a small blood sample at home. Hims' lab runs 22 biomarkers, then a licensed provider sees the patient live. The company says testosterone "was scaling faster than any other specialty outside of weight loss, just three quarters after its launch."
WIRED calls this Hims' first move into prescribing a controlled substance. Hims executive Pete Stahl, MD, told WIRED: "If you're asymptomatic, it doesn't matter what your testosterone level is, you're not going to get treated on our platform."
Testosterone is Schedule III. Prescribing it after a video visit depends on DEA's telemedicine flexibilities, which end Dec. 31 unless DEA extends or replaces them. OIRA's log shows a meeting on DEA's permanent telemedicine registration rule on Nov. 2.
The Signal
[Everyone] RFK Jr. says HHS wants a regulated peptide market
Health Secretary Robert F. Kennedy Jr. told Will Cain on Fox News on Tuesday that "virtually all peptides are illegal" and Americans are still buying them. He put that spending at "between one and a half and three billion dollars worth of peptides a year," mostly from Chinese firms. The goal, he said, is "a regulated marketplace" where buyers know what they're getting and "the factories are inspected." He also gave his own test for when FDA should act: on a safety signal, and otherwise "it's between you and your doctor." That's his view. FDA hasn't said it. He named no peptides and gave no date. We read that as intent with no terms attached.
Fox framed the segment around the FDA's peptide notice, under White House review since last week. It's a notice-stage Interim Access Policy, and its text isn't public. The American Academy of Peptide Medicine, Hims & Hers and the Alliance for Pharmacy Compounding booked time with reviewers at OIRA. The academy was set for Wednesday at 3 p.m., and nothing from that meeting had posted by evening. Hims & Hers goes Friday at 2 p.m. The compounders' trade group goes next Tuesday.
[Telehealth] Virta and Omada pitch employers on GLP-1 add-ons with outcome numbers
Virta Health and Omada Health put numbers behind the GLP-1 add-on sale in two days. Virta says GLP-1 patients on its nutrition program lost 37% more weight after a year than patients on standard GLP-1 care. That comes from its own analysis of more than 4,000 adults. Omada reported 6.0% weight loss against 3.3% for usual care over 12 weeks in 245 adults. Both pitch employers and health plans. Clinics charging a program fee on top of the drug sell the same bundle.
[Medspa] Lynch Regenerative says FDA cleared its under-eye injectable trial
Lynch Regenerative Medicine says FDA cleared its IND to test an injectable growth factor, rhPDGF-BB, for hollowing under the eyes, a problem most often treated with filler. The company pitches it as a way to regrow the patient's own tissue instead. The Phase 2 trial will enroll up to 75 people. A cleared IND allows a study, not sales.
Wire
FiDi Aesthetics and Plastics opened a consult-first practice in Manhattan's South Street Seaport, run by a plastic surgeon with nurse injectors.
Hims reports third-quarter results Nov. 9, the first earnings call since the TRT launch.
Dates we're watching: Hims & Hers meets OIRA on the peptide notice Friday at 2 p.m. The compounders' trade group meets next Tuesday. OIRA has a meeting on DEA's permanent telemedicine registration rule Nov. 2. DEA's telemedicine flexibilities end Dec. 31 unless DEA extends or replaces them.
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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.