The GLP-1 Receptor Agonist Scrum

In response to the Hims and Hers Health GLP-1 receptor agonist pill offering, FDA Commissioner Marty Makary says that the Food and Drug Administration will "take swift action" against companies mass-marketing illegal copycat drugs.  Uppermost on his mind is undoubtedly the New England Compounding Center (NECC) in Framingham, Massachusetts whose contaminated injectable epidural steroids caused a fungal meningitis outbreak in 2012 which killed more than 64 people, including 11 here in Michigan:

https://www.reuters.com/sustainability/boards-policy-regulation/novo-nordisk-shares-rebound-fda-targets-illegal-drug-copies-2026-02-06/

Novo Nordisk shares rebound as FDA targets illegal drug copies
By Jacob Gronholt-Pedersen - February 6, 2026

COPENHAGEN, Feb 6 (Reuters) - Shares in Danish drugmaker Novo Nordisk (NOVOb.CO) gained 5.4% on Friday, recovering some of the previous two sessions' steep losses, after the U.S. Food and Drug Administration (FDA) pledged to address mass-marketing of unapproved drugs.

The stock plunged nearly 8% on Thursday after telehealth company Hims and Hers Health (HIMS.N) launched a significantly cheaper $49 compounded version of Novo Nordisk's FDA-approved Wegovy weight-loss pill.

Novo's shares, which are near their lowest since Wegovy was introduced in June 2021, were 5.4% higher at 1341 GMT.

Late on Thursday, FDA Commissioner Marty Makary said on X that the agency would "take swift action" against companies mass-marketing illegal copycat drugs. "The FDA cannot verify the quality, safety or effectiveness of non-approved drugs," he said without naming any companies.

Despite the FDA statement, Bernstein analyst Christian Moore said he wasn't holding his breath for U.S. authorities to take decisive action.

"We do think people will still buy it, and don’t think the government will do anything to stop it, based on precedent," he said.

The FDA and individual states share regulatory authority over compounding pharmacies. In September, it launched a new tracker to show when ingredients were coming from FDA-inspected facilities. It also sent letters that month to companies it said were practicing deceptive direct-to-consumer advertising, including Hims, Novo, and rival Eli Lilly (LLY.N).

Novo, which on Wednesday flagged unprecedented price pressure that saw its stock plunge 17%, said on Thursday it would take "legal and regulatory action" in response to Hims' announcement but declined to elaborate further on Friday.

Eli Lilly, which is awaiting a U.S. regulatory decision on its weight-loss pill orforglipron, was also critical of the launch announcement.
"Patients deserve better than untested knockoffs that are sold without clinical evidence that they even work," a Lilly spokesperson said in an email to Reuters on Thursday before Makary's public post.

A Hims spokesperson said on Thursday the company had not compromised on safety or efficacy and used a technology based on liposomes intended to support absorption, in response to similar criticisms from Novo.

Lilly's shares, which had ended the prior session down about 8%, rose 3.8% in premarket trading.

($1 = 6.3327 Danish crowns)

Hims & Hers Health folds:

https://x.com/HimsHersComms/status/2020207947645911214

Post

Hims & Hers Comms
@HimsHersComms

Since launching the compounded semaglutide pill on our platform, we’ve had constructive conversations with stakeholders across the industry. As a result, we have decided to stop offering access to this treatment. We remain committed to the millions of Americans who depend on us for access to safe, affordable, and personalized care.

This may change in March, when Novo Nordisk's compound patent expires.

Novo Nordisk filed suit against Hims & Hers:

https://www.reuters.com/legal/litigation/novo-nordisk-sues-hims-hers-over-patent-infringement-2026-02-09/

Novo Nordisk sues Hims & Hers over patent infringement
By Stine Jacobsen - February 9, 2026

COPENHAGEN, Feb 9 (Reuters) - Novo Nordisk (NOVOb.CO), opens new tab said on Monday it has filed a lawsuit against U.S. telehealth company Hims & Hers (HIMS.N), opens new tab for infringing on the Danish group's patents.

"Novo Nordisk is asking the court to permanently ban Hims from selling unapproved, compounded drugs that infringe our patents, and is seeking to recover damages," the Danish drugmaker said in a statement.

The move comes after Hims on Saturday cancelled the launch of a $49 copy of a weight-loss pill from Novo Nordisk and the U.S. Food and Drug Administration.

The Hims and Hers' reply:

https://x.com/HimsHersComms/status/2020854864666923411

Post

Hims & Hers Comms
@HimsHersComms

Novo Nordisk’s lawsuit is a blatant attack by a Danish company on millions of Americans who rely on compounded medications for access to personalized care. Once again, Big Pharma is weaponizing the US judicial system to limit consumer choice. This lawsuit attacks more than just one medication or company – it directly assaults a well-established, vital component of US pharmacy practice that has improved patient care for everything from obesity to infertility to cancer. Hims & Hers has a long history of providing safe access to personalized healthcare to millions of Americans, and we will continue to fight to provide choice, affordability, and access.

8:38 AM · February 9, 2026

Hims & Hers Health falls on its financial sword:

https://www.reuters.com/business/healthcare-pharmaceuticals/hims-hers-forecasts-2026-revenue-above-estimates-2026-02-23/

Hims & Hers forecasts first-quarter sales below estimates, shares fall
By Sneha S K in Bengaluru; Editing by Alan Barona - February 23, 2026

Summary

• Shares fall 7% after hours
• Personalized weight-loss products generate $65 million headwind in Q1
• Overseas expansion to boost growth in non-weight-loss business

Feb 23 (Reuters) - Online telehealth company Hims & Hers Health (HIMS.N), which sells weight-loss drugs, hormone replacement therapies and health services, on Monday forecast first-quarter revenue below estimates, pushing its shares down 7% in after-hours trading.

The company said that the first quarter would be facing a $65 million burden from changes in the shipping of weight-loss products, which must be personalized for each prescription based on U.S. law.

Hims and Hers has grown rapidly as customers flocked to its cheap weight-loss drugs, which include compounded injectable versions of Novo Nordisk's highly popular Wegovy. Since those drugs are no longer in shortage, Hims is only allowed to make the medicines for customers if the dosage or ingredients are personalized.

Hims' efforts to launch compounded copies of Novo's new Wegovy pill at an introductory price of $49 per month were cut down earlier this month by the U.S. Food and Drug Administration, which said it would take action against it and other companies and referred Hims to the Department of Justice. Hims said in a regulatory filing that it is unclear what actions the regulators and DOJ may pursue. Novo also filed a patent suit against the company.

The stock is down 52% so far this year. Still, the company gave a 2026 outlook with the midpoint above analysts' estimates and vowed to stay on course.

"We plan to continue to operate like we always have," said CEO Andrew Dudum, who added the company is systematically broadening and diversifying its offerings. "It's important to remember that the majority of our revenue and profitability is driven by offerings outside of weight loss."

Hims and Hers forecast revenue of $600 million to $625 million for the first quarter, missing estimates of $653.11 million, according to data compiled by LSEG.

Hims also expects 2026 revenue to be in the range of $2.7 billion to $2.9 billion, compared to estimates of $2.74 billion.

REGULATORY RISK FUELS UNCERTAINTY

International expansion may help it grow but does not address the continuity of the company's weight-loss business, which remains uncertain due to regulatory risks, said Michael Cherny, an analyst at Leerink Partners.

"It would widen the long-term opportunity, but the more important component for the stock is how Hims progresses with its weight-loss business," Cherny said.

The company said its outlook gives "flexibility to lean into future investments" and said it will keep Hims on track for its 2030 target of more than $6.5 billion in revenue.

Hims last week said it will acquire Australian digital health company Eucalyptus in a deal valued at up to $1.15 billion. Analysts said the deal could accelerate growth for the company's non-weight-loss offerings.

Subscribers rose to 2.5 million, up 13% from the prior year.

It reported quarterly revenue of $617.8 million, an increase of 28% year-over-year, but below the analysts' average estimate of $619.22 million.

The company's product costs increased over 30%, a regulatory filing showed.

Hims' investment in its Super Bowl ad will also raise first-quarter operating costs, CFO Yemi Okupe said.

Novo Nordisk A/S and Hims & Hers Health Inc. have kissed and made up.  Novo ​and Hims will announce a new partnership to sell GLP-1 receptor agonist drugs ⁠Monday:

https://www.reuters.com/business/healthcare-pharmaceuticals/novo-hims-resolve-dispute-will-sell-obesity-drugs-together-bloomberg-news-2026-03-07/

Novo and Hims to sell obesity drugs together as feud ends, Bloomberg News reports
By Carlos Méndez in Mexico City and ​Mihika Sharma in Bengaluru - March 6, 2026

March 6 (Reuters) - Wegovy maker Novo Nordisk (NOVOb.CO), opens new tab plans to sell its ​weight-loss drugs on Hims & Hers Health (HIMS.N), opens new tab ‌platform, bringing an end to a dispute between the two companies that escalated into a legal battle ​last month, Bloomberg News reported on Friday.

Hims ​shares surged 39% in after-hours trading after ⁠the report.

The report comes nearly a month ​after Novo sued Hims over patent infringement following ​the U.S. telehealth firm's launch, and then cancellation, of a $49 copy of Novo's obesity pill.

The U.S. Food and ​Drug Administration had also threatened action against Hims.

Novo ​and Hims plan to announce a new partnership as soon ‌as ⁠Monday, the report said, citing a person familiar with the matter.

Last year, Novo ended a short-lived agreement to sell its Wegovy weight-loss drug ​through Hims ​over the ⁠company's marketing tactics and continued sales of Wegovy copies.

A Novo spokesperson said ​in an e-mailed statement the company ​is "always ⁠in conversation with companies that can help improve patient access to FDA-approved medicines".

Hims did not ⁠immediately ​respond to a request for ​comment.

The power of the greenback on full display! 😍