September 25, 2026

The need-to-know this morning

Following a trial in a California federal court, a jury yesterday found that Eli Lilly breached a contract with Nektar Therapeutics to co-develop in good faith the autoimmune disease drug rezpeg. The jury awarded Nektar $90 million in damages plus interest, an amount far less than the company was seeking.

Washington

Overton dodges senators on vaccines, abortion, China

FDA commissioner nominee Heidi Overton largely avoided declaring her stance on several issues during a contentious Senate confirmation hearing yesterday, STAT’s Margaret Manto writes. She repeatedly pointed to existing law and agency policy when pressed on vaccines, abortion, and whether she would resist political pressure from President Trump or health secretary Robert F. Kennedy Jr.

Overton affirmed that the MMR vaccine is safe and effective, but defended the administration’s push to split it into separate shots. On the abortion drug mifepristone, she would say only that the drug has met FDA standards, despite previously co-authoring a brief describing medication abortion as a threat to women’s health. She was more forthcoming on China:

“Slow and prohibitive requirements for cutting edge therapies at the FDA means investment is increasingly flowing to China who has found ways to do things faster and cheaper,” Overton said in her opening statement. “We must reverse this trend.”

podcast

The FDA's Overton era, and dispatches from Shanghai

STAT’s Jason Mast joins this week's episode of "The Readout Loud" from Shanghai, where he’s digging into what the rise of Chinese drug development means for the biotech industry.

The hosts also speak to colleague Margaret Manto about Heidi Overton, the president’s pick to be commissioner of the Food and Drug Administration. Will the new nominee bring some needed stability or controversy to the troubled agency?

Listen here.

diabetes

Lilly wins approval for once-weekly insulin shot

The FDA approved Eli Lilly’s Onswik, a once-weekly basal insulin for adults with type 2 diabetes, offering patients an alternative to daily long-acting insulin injections. The drug, also known as insulin efsitora alfa-gobe, met its primary goal across four late-stage studies involving more than 3,400 patients. It lowered A1C by an amount that was not inferior to glargine, a daily insulin.

Lilly estimates the weekly dosing could eliminate more than 300 injections a year, and plans to launch Onswik in the U.S. in the coming months. The drug, which is already approved in Europe, Japan, and Mexico, should not be used in people with type 1 diabetes because of an increased risk of severe hypoglycemia.

Lilly’s Onswik will compete with Awiqli, a once-weekly insulin shot from Novo that the FDA approved in March.

ipos

RNAi player City Therapeutics files for IPO

City Therapeutics, an RNAi biotech cofounded by former Alnylam CEO John Maraganore, filed to go public on the Nasdaq under the ticker CTY. The company was founded just three years ago, and has since raised about $239 million from investors, including ARCH Venture Partners, Fidelity, Invus, and Viking.

City’s lead drug, CITY-FXI, is an RNAi therapy that targets Factor XI to prevent blood clots. An early Phase 1 study showed it brought down levels of the Factor XI protein by about 85%. The company will release more data later this year, and has a Phase 2 study planned for 2027.

It’s also developing RNAi drugs for Stargardt disease and anemia of chornic disease, and has partnerships with Bausch + Lomb and Biogen for eye and neurological diseases.

More around STAT