Listen Labs walked away from a signed Series C term sheet from Menlo Ventures, sources say.

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First came the new teaser for Nathan Fielder’s documentary on Elizabeth Holmes. Now come the memes. Bring it on.

FDA names permanent heads of drug and biologics centers

For the past few months, key centers at the FDA have been led by acting officials. The agency said yesterday it will now make them permanent. Michael Davis will be director of the Center for Drug Evaluation and Research, and Karim Mikhail will be director of the Center for Biologics Evaluation and Research.

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Today, we delve into how an FDA approval paradoxically complicated access to Revolution Medicines’ new pancreatic cancer drug for some patients, see standout mid-stage results for Roivant’s pulmonary hypertension drug, and more.

Hope you had a lovely long weekend! Estoy trabajando en este Readout de la Biblioteca Vasconcelos en la CDMX.

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Hi! Hope you had a nice extended weekend.

Today: Eli Lilly’s gene-editing data seems promising for high cholesterol, an AI drug discovery CEO dispelled some AI drug discovery hype, and the new interim FDA chief is so far well received.

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Merck’s bet on an antibody-drug conjugate developed in China has paid off in a major Phase 3 lung cancer study, where sacituzumab tirumotecan paired with Keytruda sharply outperformed Keytruda alone in a subset of lung cancer patients.

Also, the NIH is down another leader, and Sam Altman-backed longevity startup Retro Biosciences raises more funds.

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CAR-T therapies are continuing to gain traction in autoimmune disease, with a notable new case.

Also, the FDA has withdrawn approval of GSK’s leucovorin for a rare brain disorder tied to autism, closing out an unusual episode shaped in part by political pressure.

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PhRMA CEO Steve Ubl is stepping down. Biotech investors are grappling with pressure from AI and rising competition from Chinese labs, even though firms sit on large cash reserves.

Also, the Trump administration is stepping back from the “indirect cost” fight at the NIH, and new data suggest genetics may modestly influence responses to GLP-1 drugs.

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An abdominal aortic aneurysm is a life-threatening vascular condition with limited treatment options. 

Now, researchers from the University of Michigan Frankel Cardiovascular Center have identified a driving force behind the condition, opening up a potential target for new therapies. Their paper uncovering the causal link between triglycerides and abdominal aortic aneurysms won the STAT Madness 2026 popular vote. 

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For her new research on the brain’s plumbing system, neuroscientist Maiken Nedergaard had to hone many techniques. Among them — coaxing her lab mice into restful sleep, even as they lay on microscope beds with tiny fiberoptic wires threaded into their brains.  

“It was really hard to get the mice to sleep naturally,” said Nedergaard, who spent weeks cuddling the animals in her hands, so they’d learn to feel safe. “But then we said, ‘we really want to not have them disturbed.’”

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WASHINGTON — The Food and Drug Administration used the president’s budget to propose policies aimed at encouraging domestic development and manufacturing of drugs.  

FDA Commissioner Marty Makary has said the agency needs “giant, big ideas” to counter China’s dominance in early-stage clinical development of drugs. Among the FDA’s ideas are proposals to make it easier to run early-stage trials in the U.S. and to hand an advantage to U.S.-based generics manufacturers.

The Trump administration has been using a variety of policy levers to try and bring drug manufacturing to the U.S. For example, many of the brand drugmakers that struck deals to lower U.S. prices also promised to increase domestic manufacturing, under the threat of tariffs.

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A four-month FDA delay prompted a cash-strapped biotech company to shutter. The White House’s proposed NIH cuts are drawing bipartisan backlash. Peptide hype is outpacing evidence. And more!

The need-to-know this morning

• Neurocrine Biosciences said this morning that it would buy Soleno Therapeutics and its treatment for Prader-Willi syndrome for $2.9 billion. Neurocrine is paying $53 a share for Soleno, a 34% premium to its closing price on Thursday.
  

A four-month FDA delay derailed a small biotech. Is it a sign of the times?

FDA delays can happen. For large drugmakers, they can be frustrating; for small drugmakers, they can be existential.

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