The study published in the Lancet analyzed data from 381 patients with platinum-resistant ovarian cancer, revealing a 35% reduction in the risk of death among those treated with relacorilant compared to usual care.
The news is the latest sign of the FDA's heightened scrutiny of vaccines under Health Secretary Robert F. Kennedy Jr., particularly those using mRNA technology, which he has criticized before and after becoming the nation's top health official. Moderna received what's called a "refusal-to-file" letter from the FDA that objected to how it conducted a 40,000-person clinical trial comparing its new vaccine to one of the standard flu shots used today.
While the move came as a surprise to the high-profile vaccine maker, it is just the latest hostility toward vaccines-and mRNA vaccines in particular-from an agency overseen by the fervent anti-vaccine activist Robert F. Kennedy Jr. In his first year in office, Kennedy has already dramatically slashed childhood vaccine recommendations and canceled $500 million in research funding for mRNA vaccines against potential pandemic threats.
We knew that if you inject these nanoparticles into an animal model, the nanoparticles get taken up by antigen presenting cells and this resulted in increased regulatory T-cells and decreased inflammatory disease. However, we did not know how this happens,
As for side effects, the companies reported that little had changed from previous analyses; adverse events were similar between the two groups. The top side effects linked to the vaccine were fatigue, injection site pain, and chills. The results "highlight the potential of a prolonged benefit" of the vaccine combined with Keytruda in patients with high-risk melanoma," Kyle Holen, a senior vice president at Moderna, said. They also "illustrate mRNA's potential in cancer care," he said, noting that the company has eight more Phase 2 and Phase 3 trials going for mRNA vaccines against a variety of other cancers, including lung, bladder, and kidney cancers.
EMPAVELI is the first and only approved treatment for C3G and IC-MPGN across pediatric patients 12+, adults, and post-transplant recurrence. That's roughly 5,000 patients in the U.S., with EMPAVELI holding exclusive approval for about two-thirds. Add the European CHMP positive opinion in December 2025, and you have a rare disease franchise with global expansion potential and pricing power that typically commands gross margins north of 90%.
Eduardo Vilar-Sanchez has spent more than 10 years pursuing a goal that seemed very distant, but which he now sees as a little closer: to develop a preventive vaccine against cancer. The physician and researcher is leading a study that presented the first promising results of a colon cancer vaccine in a small group of patients suffering from a rare disease that makes them 17 times more likely to develop colon cancer than the general population.