April 6, 2026

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.

regulation

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.

Kezar Life Sciences, a small biotech based in South San Francisco, tells STAT's Elaine Chen it learned the hard way, after the FDA abruptly canceled a key trial design meeting late last year.

Without regulatory clarity, Kezar couldn’t raise money and laid off most of its staff of about 60 people. It began selling off assets, even though its experimental drug for autoimmune hepatitis showed early promise in patients. By the time the FDA finally met with the company and aligned on a viable path forward, it was too late.

“Drug development is an extremely hard and extremely risky and extremely capital intensive activity, and we’re trying to do the best we can to serve patients who don’t have the right drug or any drug,” CEO Chris Kirk told STAT. “When the FDA puts in roadblocks like this that creates hurdles that are sometimes just too high, that defeats the purpose of what we’re trying to do as an industry.”

biotech

Stealth biotech Stipple bets on secretive ADCs

From STAT’s Allison DeAngelis: Stipple Bio, a stealth new Bay Area startup, just launched with $100 million to develop antibody drug conjugates, targeting unique epitopes that latch onto cancer cells. But it’s staying hush on which diseases it’s targeting, and which cancer cells the ADCs are designed to hit while saving healthy tissue.

Funding comes from RA Capital, a16z Bio+Health, Nextech Invest, Yosemite, GV, and LoLa Ventures, giving the company enough cushion to fuel its operations into 2029. Beyond that, CEO Jeff Landau is being what he calls “strategically coy” on most of the company’s work.

“In today’s day and age, the competitive landscape for copying somebody’s technology is profound. There will be copiers for us once we disclose it,” he said. Yes, there is a flood of resources into fast-moving Chinese laboratories, which concerns him. But Landau says company executives are so sure they’re onto something big that they’re also wary of their neighbors in Cambridge’s Kendall Square catching on to what they're doing.

Stipple Bio isn’t alone. More and more, startups and their investors are guarding their work closely. “We're going into an era of hyper competition, and I think everybody's going to have to get much more savvy about how they play,” Naveed Siddiqi, a senior partner in venture investments at Novo Holdings, said during the J.P. Morgan Healthcare conference earlier this year.

Secrets always get out, though, particularly in biotech. Details on Stipple’s work will inevitably be unveiled by early next year, when the company anticipates starting its first clinical trial.

SCIENCE

Understanding how thin science fuels peptide hype

Health secretary Robert F. Kennedy Jr. is embracing experimental peptide drugs while at the same time calling for more scrutiny of well-established vaccines. The conflicting signals are no accident, STAT’s Sarah Todd writes; instead they reflects a growing sort of medical libertarianism driving the wellness economy.

When it comes to peptides, influencers and biohackers are fueling demand for these largely unproven compounds, citing their use in self-optimization. But these substances are often sourced from gray and black markets, and data are scant — with most coming from animal, not human, studies. There’s real concern around contamination, unknown side effects, and even cancer risk.

Proponents will say “‘thousands of people have taken these peptides so if they were dangerous, we’d know by now,’” said UC Davis cell biology expert Paul Knoepfler. (Knoepfler is also a STAT contributor.) “This is a big gamble. For many potential risks from peptide use, signals may not yet be clear. For example, cancer risk may emerge only 3-5 more years down the road or longer.”

WASHINGTON

White House proposes NIH cuts, but there's blowback

The White House is proposing a roughly $5 billion cut to the NIH budget, and wants to restructure the agency to shrink its various institutes. It’s also asking Congress to reduce funding for ARPA-H, which funds cutting-edge science, from $1.5 billion to $945 million. Among the agencies it wants to cut are the National Center for Complementary and Integrative Health, and the National Institute on Minority Health and Health Disparities.

But the plan is already running into bipartisan resistance in Congress, where lawmakers have historically protected NIH funding. Sen. Susan Collins, a Republican from Maine who chairs the Appropriations Committee, called the biomedical funding cuts “unwarranted” in a statement.

But the agency is already in triage mode, thanks to a series of internal changes — from fewer grants to disrupted international collaborations to understaffed advisory councils.