December 11, 2025

The need-to-know this morning

Rezolute said its experimental drug failed to reduce episodes of low blood sugar in patients with congenital hyperinsulinism, missing the efficacy goal of a Phase 3 trial.
AC Immune said its immunotherapy showed the potential to slow the progression of Parkinson's disease, based on preliminary results from a mid-stage study.
Rhythm Pharma announced preliminary study data showing its drug could reduce hunger cravings and lower the BMI of people with Prader-Willi Syndrome.
Geron announced a corporate restructuring, including a one-third reduction in its workforce.

obesity

Lilly's triple-G drug leads to major weight loss, but with many discontinuations

Eli Lilly's next-generation obesity drug led to what appears to be the most weight loss seen so far in a late-stage trial, but rates of side effects were high and many participants discontinued the treatment, including people who felt they were losing too much weight.

In a 68-week study of patients with obesity and knee osteoarthritis, those who took the highest dose and stayed on the drug, called retatrutide, lost 28.7% of their weight. When analyzing all treated participants, including those who discontinued, the efficacy was 23.7%.

Among the cohorts of treated patients, discontinuation rates due to adverse events ranged from 12% to 18%, compared with 4% in the placebo group. Lilly said this "included discontinuations for perceived excessive weight loss."

obesity

Small study of Corbus' CB1-targeting pill shows positive signal

Corbus Pharmaceuticals said this morning that its investigational obesity pill led patients to lose weight in a short Phase 1 trial, though longer and larger studies will be needed to confirm the efficacy of the drug.

After taking the pill daily for seven days and being observed for seven more days, a cohort of nine patients with obesity lost on average 2.9% of their weight, a notable amount in such a short time period.

The treatment, called CRB-913, is an inverse agonist of CB1 receptors, a mechanism with a troubled past.

A much earlier obesity treatment that blocked CB1 receptors, called rimonabant, was pulled off the European market in the 2000s due to concerns it was linked to a higher risk of suicidal ideations. More recently, Novo Nordisk and Skye Biosciences have released data on new CB1 candidates, but Novo's drug led only to modest weight loss and Skye's failed in its trial.

Corbus said its candidate is different from the early drug rimonabant, since it has much lower brain penetration. Researchers conducted daily neuropsychiatric assessments and did not detect any cases of suicidality, depression, or insomnia, the biotech said.

Politics

A watered-down Biosecure Act nears passage

Congress is finally set to pass the Biosecure Act, a bill meant to restrict how U.S. biopharma companies do business with Chinese companies that are determined to be working with the Chinese military and Communist Party.

But since the bill was first introduced two years ago, incremental changes have watered it down and made it more palatable for U.S. companies.

The House passed a defense budget bill yesterday that includes Biosecure, and the Senate is expected to vote next week.

business

Health insurers are bailing on JPM again

The largest health insurers will not be presenting at the annual J.P. Morgan Healthcare Conference for the second year in a row.

Companies including Centene, Cigna, CVS Health, and Humana are not on the initial agenda for the January conference, even though they've frequently presented in prior years. UnitedHealth Group and Elevance Health are also not attending, but they usually don't.

The killing of UnitedHealthcare CEO Brian Thompson last December still looms over the insurance industry. Last year, several major insurers pulled out of JPM after the killing, even as the bank stepped up security.

Read more from STAT's Tara Bannow and Bob Herman.

drug development

A nonprofit gets an FDA approval for the first time

The FDA this week approved a new gene therapy made not by a drug company, but by an Italian charity.

The drug, Waskyra, treats a rare immune disorder called Wiskott-Aldrich syndrome. The Telethon Foundation, the organization behind the therapy, said it hopes this sets the stage for more nonprofits to license and develop drugs that companies have abandoned.

Over the past few years, the biopharma industry has fled the genetic medicine field, finding that the complex treatments for extremely rare conditions are are too difficult to commercialize.

obesity

Wave's 'gym bro' obesity drug is story over substance

My colleague Adam Feuerstein offers a contrarian take on Wave Life Sciences in his Biotech Scorecard newsletter today.

Wave Life Sciences is developing a weight loss drug that, in its first clinical trial, resulted in study participants gaining weight.

The result is the opposite of what you want to see in a weight loss drug, yet when Wave reported the early stage study results on Monday, its stock price tripled. Days later, the company raised $350 million from investors, and Wave is now valued at $3.8 billion.

How did Wave manage to transform an ineffective weight loss drug, called WVE-007, into a Wall Street sensation? By telling a clever and engaging story that shifted the focus of WVE-007 from weight loss (which it didn't do) to change in "body composition."