The need-to-know this morning

Kailera Therapeutics raised $625 million in an initial public offering — the largest-ever Wall Street debut for a drug company. Kailera is developing obesity drugs licensed from China.

obesity

Do we even need GLP-1 anymore?

The scientists whose work helped spur the development of GLP-1-based obesity drugs are now questioning whether that target is necessary at all. Instead, they’re proposing that using GIP-glucagon as a dual target could deliver comparable — or even superior — weight loss, without the nausea and dosing limitations that come with current therapies.

A group of researchers led by GLP-1 pioneers Richard DiMarchi and Matthias Tschöp, and funded by a biotech called BlueWater Biosciences, saw in animal studies that an experimental drug matched or exceeded the effects of triple-agonist treatments like retatrutide, even in models where GLP-1 signaling was absent.

In a new paper, the researchers are trying what they call “addition by subtraction” — the idea that “you're actually getting to something that's superior by taking something away,” DiMarchi told STAT’s Elaine Chen.

podcast

A pancreatic cancer breakthrough, and new hope for an off-the-shelf CAR-T treatment

On this week’s episode of "The Readout LOUD": a pancreatic cancer breakthrough and new hope for an off-the-shelf CAR-T treatment in lymphoma.

Your favorite biotech podcasting crew is back to full strength this week, and we’re bringing you two newsy guest interviews. First, we’ll talk with Allogene Therapeutics Chief Medical Officer Zach Roberts about new study results that bolster the company’s efforts to develop an off-the-shelf CAR-T therapy for B-cell lymphoma, a type of blood cancer.

Then, we’ll dive into the biggest news of the week: Revolution Medicines and the stunning survival benefit reported for its experimental drug in a Phase 3 pancreatic cancer study. Paul Oberstein, a pancreatic cancer expert from NYU Langone, will join us to discuss the Revolution Medicines data and what it means for pancreatic cancer patients.

Listen here.

REGULATION

FDA eyes expanding testosterone therapy for libido

From STAT’s Annalisa Merelli: The FDA said yesterday that it is considering adding an indication for testosterone replacement therapy (TRT), based on evidence that therapies could be effective in the treatment of low libido in men with idiopathic hypogonadism (that is, low testosterone without a known cause). There are several FDA-approved testosterone products, all currently indicated only for the treatment of men with hypogonadism that is linked to either genetic or structural causes.

The makers of FDA-approved testosterone products have until April 30 to submit an application and necessary data. This step follows a panel hosted by the FDA in December 2025, during which experts made the case for the expansion of TRT access.

“What’s important about today’s announcement is that the FDA has now officially recognized that men without any known cause for [testosterone] deficiency are candidates for treatment,” said Abraham Morgentaler, a faculty fellow in health and longevity at Harvard Medical School. “While today’s news is a win for men’s health, I don’t believe it goes far enough. Many other symptoms of low T are not addressed, but should be,” he said.

“Low libido is a smart place to start — it’s clinically meaningful, measurable, and directly tied to testosterone biology,” said Helen Bernie, the director of men’s sexual and reproductive health at Indiana University and a professor of urology. She, too, hopes to see reviews for other indications soon. “While important and rigorous, she said, “this is a step forward, not a finish line."

psychedelics

Trump considers ibogaine order, despite lagging evidence

The Trump administration is preparing an executive order to expand federal research into ibogaine, CBS News reported yesterday. It’s a Schedule I psychedelic that’s drawing interest for the treatment of PTSD, addiction, and brain injury — even though it comes with risks and clinical evidence remains thin.

The move wouldn’t legalize the drug, but could open funding pathways as officials try to determine whether ibogaine is a legitimate therapy or overhyped retreat medicine already sending Americans to loosely regulated clinics abroad.

So far, the data comes from mostly small, uncontrolled studies, with just one randomized trial. There’s growing concern about cardiac toxicity — including documented deaths — though a tiny Stanford study suggests magnesium might mitigate risk.