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Good morning. We’ve made it to the end of the week! I don’t know about you, but it’s felt like an especially long week for me. It’s probably cause of all the news that we will get into right now.
The need-to-know this morning
EMA issues negative opinion on Leqembi
From STAT’s Andrew Joseph: European regulators said today that Leqembi, the Eisai and Biogen Alzheimer’s medicine that’s approved in the U.S. and a number of other countries, should be rejected. In its statement, the European Medicines Agency said the benefits of Leqembi did not outweigh the risks associated with its class of therapies, namely a condition called ARIA that involves brain swelling and bleeding.
The ruling by the EMA (which needs to be confirmed by the European Commission) is likely to reignite the debate about the modest benefits seen with treatments like Leqembi and the side effects they carry. It also raises the stakes for Eli Lilly’s amyloid-clearing treatment donanemab.
The worst for Dexcom may not be over
Shares of Dexcom plummeted nearly 40% in post-market trading yesterday, after the company lowered its full-year sales guidance.
The maker of continuous glucose monitors is now forecasting $4 to $4.05 billion in sales this year, down from the $4.20 to $4.35 billion it had guided last quarter. On the earnings call, executives attributed this lowered guidance to slower growth in new customers (due to a disruption in the expansion of its sales force) and lower revenue per customer (due to rebates and weak performance in the durable medical equipment setting).
The move came as a shock, and on the earnings call, analysts appeared unsatisfied with the explanations executives were giving on why they lowered guidance. “This is such a step change in the business, and the outlook, and the trends,” JPMorgan analyst Robbie Marcus said on the call.
Marcus asked if the impact of GLP-1 drugs on type 2 diabetes patients played a role, but executives did not address that in their response.
Looking ahead, it’s hard not to see Dexcom’s business being impacted by GLP-1 drugs, Mizuho analyst Jared Holz said. As more patients go on the treatments, it’s likely that fewer people will progress to developing type 2 diabetes or developing severe diabetes, thereby reducing the demand for CGMs.
The “scariest” part of the lowered guidance and stock plunge are that they’re happening “before the Company sees an impact from GLPs,” Holz wrote in a note. “We believe there is no doubt that the Company and industry feel pressure from the tens of millions of patients that begin to use the weight-loss therapies.”
Pfizer’s dashed hopes in gene therapy
Pfizer had grand plans in gene therapy — it had pumped $800 million into “state-of-the-art” manufacturing facilities and said it wanted to become an “industry leader” in the field. But currently, it’s not clear how much the pharma giant has to show for all the talk.
New data from its hemophilia A therapy have left open questions on how many patients would actually want to switch to the treatment. A hemophilia B gene therapy was approved in April but faces competition. And a Duchenne muscular dystrophy treatment, the linchpin of the portfolio, failed to show any benefit in a large trial last month.
“I think we promised probably too much without really understanding the limitations,” said someone close to Pfizer’s gene therapy program who requested anonymity. “We projected hope rather than reality. We didn’t know.”
Read more from STAT’s Jason Mast.
Roche put on the defensive on its obesity pipeline
On its earnings call yesterday, Roche faced an onslaught of questions about how its early-stage obesity drugs stand apart in the fiercely competitive field and how it will position itself given the company is years behind competitors like Novo Nordisk and Eli Lilly.
CEO Thomas Schinecker said that while its obesity drugs (which Roche got through its acquisition of Carmot Therapeutics) have the same targets as Wegovy and Zepbound, subtle differences in the compounds could set them apart.
It’s worth remembering, though, that if Roche’s drugs do get approved, by the time they make it onto the market, Novo and Lilly will likely already be out with even more effective next-generation compounds.
Read more from STAT’s Andrew Joseph.
How is UnitedHealth similar to Standard Oil?
Is Viking Therapeutics an attractive acquisition target? And — most importantly — is Adam Feuerstein good at math?
I cover all these topics and more with my colleagues in the latest episode of our biotech podcast, “The Readout LOUD.” Aside from testing Adam’s ability to do mental subtraction, we also chat about STAT’s latest investigation into UnitedHealth’s sprawling physician empire, Viking’s sped-up plans in obesity, and the departure of a long-time FDA official.
Kamala Harris’ upbringing by a cancer researcher
As Kamala Harris emerges as the likely Democratic presidential candidate, STAT took a look back at the work of her late mother, prominent breast cancer researcher Shyamala Gopalan, and how Gopalan’s experiences have shaped Harris’ views on health issues.
In Harris’ memoir, she discussed her mother’s work with the NIH as a peer reviewer and collaborator. “If we want our children to have cures for humanity’s most terrible diseases, we should invest in our national medical researchers, instead of relying on companies that would rather funnel money to their shareholders,” Harris wrote.
Gopalan died of colon cancer, and Harris has also talked about how her mother’s illness changed how she thinks about health care. “I remember thanking God she had Medicare,” Harris wrote in a 2018 op-ed. “I believe that health care should be a right, but the reality is that it is still a privilege in this country. We need that to change.”
Read more from Rohan Rajeev.
Correction: In yesterday’s newsletter, Emil Kakkis’ name was misspelled.