August 20, 2025

The need-to-know this morning

Rocket Pharmaceuticals said it received clearance from the FDA to resume a clinical trial for its gene therapy to treat a rare heart condition called Danon disease. Regulators suspended the study of the experimental therapy in May following the death of a patient from immune-related side effects.

exclusive

Radiopharma startup taps former FDA head

Nucleus RadioPharma has hired former FDA commissioner Stephen Hahn as its CEO, the startup exclusively told STAT.

Nucleus is a contract development and manufacturing company for radiopharmaceuticals, a hot area for oncology drug development in recent years. The company's goal is to make these products accessible to patients around the world — a challenging mission, since the treatments use radioactive isotopes that are decaying hour by hour and need to be rapidly produced and shipped to patients.

With the new role, Hahn is returning to the field in which he got his start. Long before he served in the FDA under the first Trump administration, he led the radiation oncology departments at the University of Pennsylvania’s Perelman School of Medicine and MD Anderson.

Read more from STAT's Allison DeAngelis.

heatlh economics

GLP-1s drugs are set to drive up employer costs

Employers expect health care costs to rise by a median of 9% next year, according to a new survey from the Business Group on Health.

The biggest culprit? Increased use of GLP-1 drugs (e.g. Novo Nordisks's Wegovy and Ozempic and Eli Lilly's Zepbound and Mounjaro).

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The survey includes 121 employers who cover 11.6 million people. The projected increase of 9% is up from an estimated 8% this year and reported increases of 7.5% in 2024 and 6.8% in 2023.

obesity

Was the reaction to Viking's oral data overblown?

Viking Therapeutics yesterday released highly anticipated top-line data on its oral peptide candidate: Patients on the highest dose of 120 mg lost 12.2% of their weight after 13 weeks, but the tolerability didn't look great. Across all the treated groups, 28% of the participants discontinued treatment, compared to 18% of placebo subjects.

Viking's stock plunged 42%.

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Some people think the reaction wasn't warranted.

Leerink analyst Thomas Smith wrote that the study was designed with a fairly fast titration schedule, and the side effects could be mitigated in future studies with slower titration.

Additionally, the pill could fit into a treatment regimen with the injectable version of this drug, called VK2735, which has competitive Phase 2 results. The idea is that patients could first start on the injection for the initial weight loss, and then transition to the pill for weight maintenance, Smith wrote.

In the trial, Viking did study the possibility of using the pill for maintenance. In an exploratory dosing cohort, patients received 90 mg for four weeks, and then transitioned to 30 mg for seven weeks. At week 3, patients lost 5% of their weight, and that amount increased to 9% by week 13.

Stifel analyst Annabel Samimy also wrote that this data show the pill does have a potential role for maintenance, which is “a commercially-viable and market-expanding opportunity.”

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