July 31, 2025

The need-to-know this morning

Alnylam Pharma raised its revenue outlook as its heart drug sees quick uptake.
Biogen, Argenx, Sanofi, and Bristol Myers Squibb reported second-quarter earnings.
AbbVie and Apellis Pharma reported earnings, too.

POLITICS

Inside the undoing of Vinay Prasad at the FDA

Vinay Prasad's short-lived but polarizing run as head of the FDA's biologics division ended just 84 days in, after his aggressive push to tighten oversight on gene therapies and Covid-19 vaccines drew heat from all sides — Trump allies, RFK Jr. loyalists, Democrats, and Duchenne patient advocates.

His decision-making on Sarepta Therapeutics' gene therapy— which he viewed as backed by staff and rooted in safety concerns — fueled political pressure that only mounted after far-right influencer Laura Loomer launched a campaign highlighting his progressive leanings and past anti-Trump comments. A powerful and extremely online regulator ran out of friends when it mattered most.

STAT's Lizzy Lawrence and a team of STAT reporters walk through how it all went down. Read more.

And for more analysis, read Matthew Herper's take on why Prasad's ouster might not be such a good thing. Read more. What does it mean for the biotech industry? Adam Feuerstein has some thoughts.

BIOTECH

Moderna announces layoffs

Moderna announced layoffs Thursday affecting 10% of its workforce, or more than 500 employees, as part of an ongoing effort to reduce operating costs amid government and competitive challenges to its vaccine business.

Already this year, Moderna has pruned research, manufacturing, and other costs in an effort to reduce annual operating expenses by approximately $1.5 billion by 2027. Job cuts, unfortunately, were also necessary to meet the company's restructuring goal, said Moderna CEO Stéphane Bancel, in a note sent to employees and shared with STAT.

Frazier raises $1.3 billion despite biotech slump

Frazier Life Sciences has closed a $1.3 billion fund — its largest ever, and a rare bright spot in biotech's bleak funding landscape. The Palo Alto-based venture firm exceeded its target despite investor skittishness, rising interest rates, and dwindling returns across the sector.

While VCs debate whether company formation is slowing for good, Frazier is doubling down on its core strategy, STAT's Allison DeAngelis writes: It's spinning out startups around underdeveloped drug candidates from academia and industry.

"For us, the biggest issue with de novo company creation is less about the reduction in academic funding or China, and more that no one is getting value for preclinical work anymore," general partner Dan Estes told STAT.

hiv

mRNA vaccine for HIV clears major scientific hurdle

In a rare win for HIV vaccine development, researchers have used mRNA technology to overcome a long-standing hurdle: getting the immune system to produce neutralizing antibodies. By engineering the vaccine to conceal a distracting part of the virus's envelope, scientists triggered infection-blocking antibodies in 80% of human participants, up from just 4% in earlier designs, STAT's Jonathan Wosen writes.

The findings, published in Science Translational Medicine, mark a major scientific step — though the antibodies lack the broad protection needed for a viable vaccine. While the shots were generally safe, a surprising number of partcipants developed hives — raising safety concerns at a time when the mRNA platform is under political fire, and HIV funding is being slashed.

cARDiOLOGY

Mounjaro matches Trulicity in heart outcomes

In a long-anticipated study, Eli Lilly's Mounjaro failed to outperform its predecessor Trulicity in reducing major cardiovascular events in Type 2 diabetes patients. It did, however, meet the goal of non-inferiority — solidifying its reputation as a strong, dual-acting GLP-1/GIP drug that effectively lowers blood sugar and weight, STAT's Elaine Chen writes.

Though not statistically superior, Mounjaro showed an 8% lower risk of heart-related complications and a 16% lower risk of death from any cause compared to Trulicity, with side effects primarily gastrointestinal. Doctors will likely continue to prescribe it widely, while attention now turns to Lilly's weight loss counterpart, Zepbound, and whether the addition of GIP confers broader cardiovascular benefit.