December 18, 2025

The need-to-know this morning

Takeda said its oral drug zasocitinib induced "clear or almost clear skin" in more than half of patients with moderate to severe plaque psoriasis. Approximately 30% of patients achieved "completely clear skin." The drug achieved all the efficacy goals of two randomized, controlled Phase 3 clinical trials. Takeda intends to submit zasocitinib for FDA approval in 2026.

obesity

Lilly's pill helped as a maintenance therapy

Eli Lilly announced this morning that its investigational obesity pill largely helped patients maintain their weight loss after they switched from injectable treatments Wegovy and Zepbound, results that could widen the appeal for the pill.

While some investors were disappointed in the efficacy of the pill, called orforglipron, in prior Phase 3 trials, the latest data suggest the drug could be useful for patients who want to transition off injections, which can be inconvenient to administer.

obesity

Employers point workers toward pharma DTC programs as they drop GLP-1 drug coverage

HCA Healthcare, one of the largest hospital systems in the U.S., recently told employees it would stop covering blockbuster obesity drugs Zepbound and Wegovy next year. Now it's pointing them to direct-to-consumer programs set up by Eli Lilly and Novo Nordisk.

The move, STAT's Elaine Chen writes, highlights a growing trend among employers facing soaring costs from GLP-1s, as use of the injections surges and strains health plans.

While the prices offered on DTC platforms are discounted, they remain out of reach for many patients who previously paid far less through insurance.

“There’s this unstated belief in some ways that we’re doing this [with obesity drugs] because this is more discretionary than other types of medication, and we shouldn’t have to pay for that,” said Craig Garthwaite, director of health care at Northwestern University’s Kellogg School of Management.

WASHINGTON

More drugmakers near Trump pricing deals

Several drugmakers are expected to sign pricing agreements with the Trump administration on Friday, STAT’s Daniel Payne writes. The agreements would expand a growing slate of deals that trade lower U.S. drug prices and increased domestic investment for relief from tariffs and other regulatory benefits, according to people familiar with the plans.

The agreements follow months of pressure from President Trump, who earlier this year demanded price cuts from 17 manufacturers, and are aimed at bringing U.S. drug prices closer to those paid in other wealthy countries. While the terms remain largely undisclosed, companies that have already reached deals — including Pfizer, Eli Lilly, Novo Nordisk, and AstraZeneca — have secured tariff exemptions and potential market advantages, as others like Johnson & Johnson, Merck, and Novartis remain without agreements.

inflammation

Cracking its growth story, Insmed's nasal inflammation study fails

From STAT's Adam Feuerstein: Insmed yesterday announced negative results from a mid-stage study investigating a potential new use for its approved drug, Brinsupri.

In the Phase 2 study, Brinsupri failed to reduce nasal inflammation in patients with a type of chronic rhinosinusitis. Two doses of the drug improved symptoms but no better than a placebo, the company said. Based on the results, Insmed discontinued its development program for Brinsupri in chronic rhinosinusitis.

The setback dashed Insmed’s plan to follow up Brinsupri’s initial approval this year with a second indication. In August, the Food and Drug Administration cleared the drug to treat bronchiectasis, a type of chronic lung disease. The company is also conducting studies to investigate Brinsupri as a potential treatment for hidradenitis suppurativa, an inflammatory skin condition.

Insmed shares dipped nearly 17% to $165 in post-market trading. The stock had nearly tripled in price this year on expectations that Brinsupri’s approval in bronchiectasis alone could generate billions of dollars in new sales for the company. But with $42 billion market value, Insmed was also pricing in near-perfection from the drug’s follow-on studies.

rebranding

FDA's new brain tumor warning weakens Pfizer court case

The FDA has approved a labeling change for Pfizer’s Depo-Provera birth control shot warning of a risk of meningioma, a move that could weaken the drugmaker’s defense in lawsuits brought by women who say Pfizer long knew about the tumor risk but failed to warn patients.

Plaintiffs argue studies dating back to the 1980s linked the drug’s active ingredient, medroxyprogesterone acetate, to meningioma, while Pfizer has maintained it only identified the risk in 2023 and was blocked by the FDA from updating the label. That position may now be compromised after European regulators recommended similar warnings last year and Pfizer submitted a revised label to the FDA, which was approved late last week.

An attorney representing the plaintiffs told STAT’s Ed Silverman that the FDA change is “a game changer,” but Pfizer says it stands by the safety and efficacy of Depo-Provera.

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