September 22, 2026

The need-to-know this morning

Roche reported a positive Phase 2 trial of enicepatide (previously known as CT-388) in patients with type 2 diabetes and obesity, with the drug helping patients lose weight and lower blood sugar. The company already has two Phase 3 weight loss studies ongoing and is planning on starting another pivotal trial next year looking at blood sugar control and cardiovascular outcomes.
Celldex Therapeutics said its experimental treatment for chronic hives achieved the goals of two Phase 3 clinical trials.
Ionis Pharma said an experimental therapy for a rare form of ALS prolonged survival and slowed the progression of the disease in a Phase 3 clinical trial. The RNA-based drug, called ulefnersen, is licensed to the Japanese pharma company Otsuka.

obesity

Viking drug shows potential for less frequent maintenance dosing

Viking Therapeutics said this morning that in a Phase 2 trial, its injectable obesity candidate, initially tested as a weekly treatment, still looked to be efficacious after transitioning to every-other-week or monthly dosing.

In the study, patients first took various weekly doses of the drug, VK2735, which targets the GLP-1 and GIP hormones. After 21 weeks, participants experienced about 16% to 19% weight loss, while the placebo group saw no weight loss.

Then, researchers transitioned patients to less frequent maintenance dosing. Viking said those who shifted to once-a-week and monthly dosing maintained up to 97% and 90% of their weight loss, respectively, while those who shifted to placebo maintained 61% of their weight loss.

Less frequent dosing may make the drug more attractive to patients, but the study enrolled a fairly small number of participants, and more studies are likely needed to establish the efficacy of maintenance dosing.

Viking did not disclose specific rates of side effects during the initial part of the study when patients received weekly doses, which is the period when gastrointestinal events are expected to occur most frequently. It did say that only one treated participant discontinued due to side effects during this initial part.

The company has already moved VK2735 into a Phase 3 trial slated to end next year. It’s also developing an oral version of the treatment.

cancer

FDA may view Grail's blood test favorably

As the FDA prepares to convene a group of advisers tomorrow to discuss a controversial cancer blood test from Grail, there's at least some indication the agency could take a sympathetic view of the company's data.

While the test, called Galleri, notably failed to meet the main goal of a critical study earlier this year, documents posted by the FDA ahead of the meeting don't mention the original primary endpoint. Instead, they say that for approval, a separate threshold — related to the test’s performance in the intervention arm of the study — can be used.

Shares in Grail surged over 30% yesterday.

M&A

Lexeo expands beyond gene therapies with buyout

Lexeo Therapeutics said today that it will buy Mantle Therapeutics, picking up the private biotech's candidates to treat Friedrich's ataxia, a rare genetic disorder that causes damage to the nervous system.

Lexeo has been focused on developing gene therapies, including a candidate for cardiomyopathy associated with Friedrich's ataxia that it's testing in a registrational trial. But with the acquisition of Mantle's pipeline, it'll be moving into different drug modalities, including oral treatments.

Under the deal, Lexeo will pay Mantle shareholders $8.3 million upfront and up to $21.3 million in total. The company said it will study Mantle's drug alone and in combination with its cardiomyopathy gene therapy.

pharma

Novo may be getting a better deal than expected with Medicare's Bridge program

From STAT's John Wilkerson: We already knew that Eli Lilly and Novo Nordisk are benefitting a great deal from the Trump administration's Bridge program, a pilot that covers obesity drugs for seniors at a price of $245 a month. It turns out, there may more even more benefits to this program than we originally knew.

The administration announced last week that 40 states and Puerto Rico have committed to participating in another pilot program called GENEROUS that gives state Medicaid programs access to drugs at "most-favored nation" prices. However, the administration did not specify whether GLP-1s are included.

It seems they aren't. A Lilly spokesperson confirmed the company's obesity drugs are excluded from GENEROUS and the treatments will instead be offered to Medicare at the $245 price agreed upon under the Bridge program. Novo did not say whether its treatments would be part of GENEROUS, but if we assume they're also excluded, then that would be an especially big win for Novo.

The impact on Lilly is about the same either way because the MFN prices for its obesity drugs are similar to the $245 Bridge price, according to an analysis by Thomas Hwang, director of the Cancer Innovation and Regulation Initiative at Harvard Medical School. However, the MFN prices of Novo's products are considerably lower than $245 a month, his calculations say.

Hwang estimates that, overall, excluding GLP-1 drugs from GENEROUS could reduce projected savings by $1 billion-$1.7 billion in the first year, primarily due to impacts from Novo's products.

More around STAT