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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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SAN DIEGO — When Kura Oncology decided to take aim at a protein involved in cell division and signaling, researchers reported a bonus finding: Targeting the protein, menin, didn’t just control the growth of leukemia cells, it also helped control blood sugar levels in animal studies. The biotech on Wednesday announced that it is turning that insight into a new company.

The new firm, Caspian Therapeutics, is launching with $50 million in financing to develop menin inhibitors for diabetes and other cardiometabolic diseases. The initial funding, led by BVF Partners and joined by Eli Lilly and members of Kura’s leadership team, among others, is meant to advance Caspian’s lead small molecule drug through an early-phase clinical trial in diabetes and support the development of a second candidate.

Kura will retain around 50% ownership of Caspian, and Kura CEO Troy Wilson will serve as executive chair of the new biotech’s board. Robert Spencer, who was most recently CEO of Neurommune Therapeutics and has previously led drug discovery programs at Merck, was named Caspian’s head.

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WASHINGTON — The Trump administration permanently filled four key leadership roles at the Food and Drug Administration on Tuesday, after it nominated Heidi Overton to lead the agency late last month. 

Three of the officials are serving in an acting capacity, and will take the same roles permanently, the administration said. They are Michael Davis, a psychiatrist who will be director of the Center for Drug Evaluation and Research; former Merck official Karim Mikhail, who will be director of the Center for Biologics Evaluation and Research; and Bret Koplow, an attorney who has been at the FDA since 2011 and will serve as director of the Center for Tobacco Products. 

The fourth appointee, Jared Seehafer, will serve as the FDA’s first deputy commissioner for technology and artificial intelligence. He joined the FDA as an adviser in 2025 after founding a life science software company and working in investment advising in biotech, according to his LinkedIn. Under the Trump administration, the agency has pushed its staff to use AI to speed up its review processes. 

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Good morning health tech readers!

I hope you had a wonderful long weekend.

Reach me: mario.aguilar@statnews.com

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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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You’re reading the web edition of STAT’s Health Tech newsletter, our guide to how technology is transforming the life sciences. Sign up to get it delivered in your inbox every Tuesday and Thursday.

Good morning health tech readers!

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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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WASHINGTON — People in the food world didn’t know what to expect when the Trump administration appointed a little-known Florida attorney as the FDA’s top food official in 2025. 

They knew Kyle Diamantas worked at Jones Day representing food, beverage, and tobacco-industry clients. They saw the picture of him and Donald Trump Jr. holding giant, dead wild turkeys after a hunt. He had no experience in public health, in medicine or science, or in government.

The credentials didn’t scream qualified. And Diamantas was stepping into a center rocked by DOGE layoffs and a defiant resignation by former leader Jim Jones. 

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SAN MATEO, Calif. — Peyton Greenside, CEO of BigHat Biosciences, has hot takes. 

Her company designs antibody therapies using machine-learning, but she doesn’t like demos in which people open their computers and show off how fast they can design a drug. “If you want me to design you a protein right now in six hours, I’m happy to do it,” she said.

In fact, she can do it in 20 minutes. But if you’re actually in the business of making drugs, you are still going to have to do all the downstream tests, which take time and lots of money, Greenside said. “That’s where the hard work is, is making the actual drug.” 

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Eli Lilly said Monday that a high dose of its gene-editing therapy reduced cholesterol levels by 62% in participants in a clinical trial, an early but encouraging test of whether a one-time treatment may one day help people seeking to lower their LDL, or “bad,” cholesterol.

Lilly acquired the therapy, VERVE-102, in its $1 billion buyout of Verve Therapeutics last year. Executives tout it as a potential treatment to broadly prevent heart disease, the world’s leading killer, as many patients struggle to stay on existing, more conventional medicines for reducing cholesterol levels.

There were no treatment-related serious adverse events in the Phase 1 study — a notable finding, given that Verve had to shelve its first candidate due to safety concerns. 

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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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Retro Biosciences, the longevity startup backed by OpenAI CEO Sam Altman, has raised more money at a $1.8 billion valuation, it announced Friday. 

Retro has a big mission: Add 10 healthy years to the human lifespan. It is seeking to do that by using a variety of technologies, including in vivo gene therapies, cell replacement therapies, and other approaches to spur younger, healthier cells into aging tissues. 

The company is currently running its first clinical trial — testing a pill designed to enhance the body’s ability to better clear out protein aggregates in patients with Alzheimer’s disease. Retro CEO Joe Betts-LaCroix told the audience at STAT’s Breakthrough Summit West on Tuesday that the trial is going “super good” and that researchers haven’t seen any dose-limiting toxicities. He said he anticipates releasing some data from the trial around August. 

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The Food and Drug Administration on Friday rejected — again — an experimental treatment for advanced skin cancer developed by Replimune Group. 

Replimune’s treatment, an engineered virus designed to rev up the immune system against melanoma, has been a flashpoint in a simmering debate over shifting standards at the agency.

The drug was initially rejected in July, just two months after Vinay Prasad was appointed the FDA’s head of biologics. As an academic oncologist, Prasad criticized regulators for approving drugs with limited data, and the Replimune decision was viewed as a possible sign of the stricter stance he might take at the agency.

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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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Georg Schett had two things: a young patient deathly ill with lupus, and a couple of mouse studies raising the possibility that special T cells could tame the condition.

The German physician-scientist could produce the cells — chimeric antigen receptors, or CARs — at his institution, which was half the battle. Another hurdle: The patient’s parents. “They were like, ‘Don’t do that. You’re crazy,’” recalled Fabian Müller, Schett’s collaborator at the University of Erlangen-Nuremberg. A widespread fear at the time was that T cells would trigger or worsen autoimmune disease. 

The rest of the story is the rare scientific fairy tale: The patient got better. Five years on, she is still in remission, and working in the very clinic where she was treated. Her case upended the world of autoimmune disease, driving a flood of experimentation and investment and offering new hope to millions of patients. 

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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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For some advanced cancers, sequencing the tumor genome should be one of the first steps patients and physicians take. But a new study finds that many patients never receive genomic testing and so never get the chance to know if they might have benefitted from newer, more targeted therapies.

The study, published on Tuesday in JAMA Network Open, examined how many patients diagnosed with one of five different metastatic cancers received genetic sequencing for the cancers. For most cancers in the study, roughly half of patients in the cohort received genetic sequencing. Patients with low income, Medicare or Medicaid coverage, and Black or Hispanic race or ethnicity were also less likely to receive sequencing.

Cancer medicine and research have made enormous progress over the last few decades. The overall five-year survival rate has pushed up to 70% as of 2026, and the five-year survival rate for metastatic cancer has doubled since the 1960s. That’s in large part thanks to advances in medicines and technologies that can help treat cancer, like targeted therapies that work by exploiting key cancer mutations.

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In a move that will grow its oncology pipeline, Gilead Sciences is spending more than $3 billion to buy the German biotech Tubulis, the companies said Tuesday.

The deal includes an upfront payment of $3.15 billion and up to $1.85 billion more if certain milestones are reached. It also highlights both the therapeutic and commercial promise of antibody-drug conjugates, the next-generation chemotherapy treatments that the privately held Tubulis is developing.

Gilead’s latest move comes just months after it said it would acquire Arcellx in a deal worth $7.8 billion. The two companies had already been working together on a multiple myeloma CAR-T therapy that could be approved later this year. Gilead last month also announced that it was buying Ouro Therapeutics, which is focused on drugs for autoimmune disease, for up to $2.18 billion.

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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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