A top VC helped Epstein's friend make a comeback

The biotech industry appeared to distance itself from investor Boris Nikolic after his friendship with Jeffrey Epstein came to light in 2019. But in the following years, one of the most influential biotech venture capitalists, Alexis Borisy, quietly shepherded a comeback for Nikolic, my colleague Damian Garde reports in a new exclusive.

Borisy helped Nikolic launch a fund and raise more than $100 million in 2024 and 2025, according to people familiar with the matter. Nikolic also invested in at least one startup backed by Borisy's venture firm Curie.bio, the people said.

In a statement to STAT, Borisy said he had believed Nikolic's claims of having only a passing relationship with Epstein, but records released in recent months by the U.S. Justice Department "clearly paint a very different picture of Boris' relationship with Epstein" and represent "something fundamentally different and disturbing."

"I am devastated and angry that I had been misled," Borisy added.

A STAT examination of correspondence between Epstein and Nikolic — a trove that includes hundreds of messages over their decade-long friendship — reveals they had an even deeper relationship than has been previously reported.

Nikolic said in a statement that he interacted with Epstein mainly in 2010-2015 and significantly less after that. "Therefore, in 2019 after my connection to Epstein became public, I did characterize it as 'a passing relationship….' I regret not informing Alexis in more detail," he said.

exclusive

AI-focused nonprofit launches with $500 million

Many AI efforts these days are aimed at revolutionizing drug development by designing new proteins or optimizing clinical trials. A new nonprofit will focus on less flashy research projects.

The Astera Institute, a foundation, is launching the nonprofit called Radial with at least $500 million in funding.

Radial's CEO said the organization will focus on the "unglamorous, unsexy infrastructure and tools" needed to change how scientific data are generated, shared, and built upon.

Read more from STAT's Allison DeAngelis and Brittany Trang.

politics

FDA approves leucovorin for rare disorder without trial data

The FDA yesterday approved the generic medicine leucovorin for cerebral folate deficiency, a rare brain disorder that resembles autism, while pulling back from previous statements made by top health officials that children with autism could benefit from taking the drug.

The agency granted the approval to GSK, which first introduced the branded version of leucovorin to the market in 1997, but has stopped manufacturing it. The approval will allow generic manufacturers to update their labels as well.

Notably, the FDA said that approval was based on "a systematic review of the published literature on the topic, including published case reports with patient-level information, as well as mechanistic data." It was not based on any new clinical trial data.

A senior FDA official said the agency does this kind of review in cases of extremely rare diseases, where it's not feasible to conduct a randomized, controlled trial, Endpoints reported.

That appears to be at odds with the agency's recent approach toward several gene therapies. For example, the FDA hasn't been satisfied with the data behind UniQure's Huntington's disease candidate, which was studied in comparison to an external control group based on a natural history study.

politics

A senator is probing FDA's drug rejections

Speaking of the FDA — my D.C. colleague John Wilkerson attended a press briefing yesterday hosted by Sen. Ron Johnson (R-Wis.), who has long advocated for giving people with rare diseases speedy access to experimental treatments.

Johnson said he is investigating the FDA's recent rejections and is requesting denial letters, adding that he's heard some of the issues in those letters are "nitpicky things."

glp-1s

FDA warns Novo for failing to report side effects

Novo Nordisk said yesterday that it had received a warning from the FDA for failing to report suspected incidents of side effects from its GLP-1 drugs.

In a warning letter dated last week, the FDA said the company and its call center contractors "inappropriately invalidated" reports of serious side effects due to a lack of patient identifiers, but during an inspection of Novo's facilities early last year, FDA inspectors did actually find valid patient identifiers in source documents for the reports.

The letter also said Novo failed to promptly conduct medical reviews of reported side effects.