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Welcome back to another edition of Endpoints Weekly! It’s Super Bowl weekend with the Patriots and Seahawks fighting for the championship. While our many Boston-area readers are surely excited, most of us here in New York are less than thrilled with New England’s rapid return to success after Tom Brady (finally) retired.
Let’s get into the headlines. We saw an explosive situation emerge between Hims and Novo Nordisk over a compounded version of the Wegovy obesity pill. This is a story that we’ll be keeping a close eye on, so make sure to keep it locked in at Endpoints in the coming weeks. We also have updates from Pfizer’s monthly GLP-1, more on fourth-quarter earnings, some biotech IPOs and the official launch of TrumpRx.
Also, check out our episode of Post-Hoc Live where Drew Armstrong and Shelby Livingston chatted with attorney Edgar Asebey, a partner at Frier Levitt who works on compounding and FDA issues, about how to make sense of the emerging brouhaha. Have a great weekend! — Max Gelman |
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Max Gelman |
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Senior Editor, Endpoints News |
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The Hims vs. Novo showdown |
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The telehealth provider Hims & Hers said this week it would start selling a compounded version of Novo Nordisk’s Wegovy pill, immediately setting off a back-and-forth between the companies. Novo had just launched the Wegovy pill last month, and Hims’ move to sell a cheaper and compounded version could undercut Novo’s hopes to revive its blockbuster obesity franchise.
Novo slapped back and threatened legal action, calling Hims’ plan “illegal mass compounding that poses a significant risk to patient safety” in a company statement. Novo CEO Mike Doustdar, speaking on an analyst call, also cast doubt on whether the body could absorb compounded versions, suggesting they were less effective than Novo’s brand-name pill. Formulation technologies are critical for oral drugs to protect the sometimes chemically fragile active molecules. This is particularly true for peptides like semaglutide, which the digestive system breaks down easily. It’s not clear at this time whether a legal challenge brought by Novo would succeed.
Hims, however, soon found itself in the FDA’s crosshairs. Late Thursday evening, FDA Commissioner Marty Makary posted on social media that the agency would “take swift action against companies mass-marketing illegal copycat drugs.” A federal official later told Endpoints News that Makary was referring specifically to Hims. On Friday afternoon, HHS General Counsel Mike Stuart posted to X that his office had referred Hims & Hers to the Department of Justice for investigation. |
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Pfizer’s monthly GLP-1 data |
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After winning a bidding war with Novo for Metsera, Pfizer reported the first data from its new acquisition this week. The monthly injection that was one of the cornerstones of Pfizer’s $10 billion buyout allowed obesity patients to lose up to 10.5% of their weight, on a placebo-adjusted basis, after just over six months.
Shareholders were unimpressed with the data, appearing to doubt whether the results were good enough to justify the price tag. Pfizer’s data are slightly behind the figure seen with Eli Lilly’s Zepbound, where placebo-adjusted weight loss at 28 weeks in its pivotal obesity trial was approximately 13%. However, Zepbound is given weekly. The data are also a slight drop from the 14.1% placebo-adjusted figure Metsera reported last September.
More data will be needed to truly assess the drug’s commercial potential. Pfizer only reported weight loss data from two of the four dose groups in the study, and weight loss with placebo hasn’t been disclosed either. Read more on the landscape from senior journalist Elizabeth Cairns here. |
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Q4 earnings roundup |
📊Several big pharma companies reported their fourth-quarter and full-year earnings this week. Here are some highlights:
- While Pfizer reported a positive readout from its Metsera acquisition, it also took a write-down related to its $43 billion acquisition of Seagen.
- Novo Nordisk is looking into acquiring or developing a long-acting GLP-1 drug that could compete with Pfizer’s monthly obesity shot. It also cut a handful of drugs from its pipeline.
- Eli Lilly surpassed analysts’ expectations for 2025 and fourth-quarter revenues, and anticipates a large increase in revenue this year.
- Amgen said it doesn’t plan to pull its rare disease drug Tavneos from the market, despite the FDA’s request.
- Novartis said further generic erosion of three blockbuster medicines, including its top-selling heart failure drug Entresto, will leave a $4 billion hole in its sales this year.
- GSK’s new CEO Luke Miels laid out the drugmaker’s vision for how it will meet its 2031 sales forecast and address the upcoming patent cliff for its blockbuster HIV drug dolutegravir. It was his first earnings report since Emma Walmsley left her post at the end of last
year.
- Bristol Myers Squibb flagged at least 10 potential data readouts coming this year that could lead to new approvals or label expansions for existing drugs.
- AbbVie said its newer immunology products Skyrizi and Rinvoq have together exceeded peak Humira sales by more than $4.5 billion.
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A big week for IPOs |
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📈Biotech IPOs are making a comeback. A handful of companies went public this week, including the fibrosis-focused company Agomab Therapeutics, the eye disease company SpyGlass Pharma, Roger Perlmutter-led Eikon
Therapeutics and oral Rogaine drug developer Veradermics. The four biotechs expect to reel in $987 million from their private-to-public transitions this week.
That makes it the biggest week for biotech IPOs since July 2021, according to an Endpoints News analysis by Kyle LaHucik. During the JP Morgan Healthcare Conference last month, bankers and investors told Endpoints they predicted more IPOs would occur in the spring. One other biotech, Generate:Biomedicines, also unveiled its IPO pitch this week. Click here to see Kyle’s full analysis. |
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White House launches TrumpRx |
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The direct-to-consumer hub is a key element of the administration’s push to lower drug prices. The website launched with 43 medications, including Novo Nordisk’s Wegovy pill, with more to be added “week over week,” National Design Studio Director Joe Gebbia said. It included drugs from the first five companies to strike “most favored nation” agreements with the White House — Pfizer, AstraZeneca, EMD Serono, Eli Lilly and Novo Nordisk. But a number of products also have generics
available elsewhere. Check out Max Bayer’s analysis here. |
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