May 1, 2025

The need-to-know this morning

Madrigal Pharmaceuticals reported $137.3 million in first-quarter sales for its MASH drug Rezdiffra, topping consensus analyst estimates. It's been a good week for biotech drug launches, with BridgeBio and Verona also posting strong results.
Biogen reported first-quarter earnings, including better-than-expected $96 million in sales of Leqembi, its Alzheimer's treatment co-marketed with Eisai.
Even more earnings reports from Blueprint Medicines, Alkermes, and Alnylam Pharma.

pharma

Eli Lilly falls as Novo secures major insurance win

Shares of Eli Lilly dropped in pre-market trading this morning, as competitor Novo Nordisk secured a major win on insurance coverage and as Lilly reported first-quarter earnings that fell short of investors’ expectations.

CVS Caremark, the largest pharmacy benefit manager in the U.S., announced today that starting in July, Novo’s weight loss treatment Wegovy will be the preferred GLP-1 medicine on its largest commercial formularies, likely making Wegovy more accessible to patients than Lilly’s weight loss treatment Zepbound.

Also this morning, Lilly reported sales of Zepbound and the sister diabetes drug Mounjaro that were roughly in line with analysts’ estimates. Investors, though, were hoping for greater numbers, said Mizuho analyst Jared Holz.

Vaccines

Moderna makes more spending cuts, updates vaccine plans

From STAT's Jason Mast: Moderna said this morning in its earnings report it planned to cut costs by around $1.5 billion by 2027, adding $700 million to $1 billion on top of more modest cuts announced last year.

The company has continued to face long-standing questions from its investors about its post-pandemic business, along with new concerns about what vaccine-skeptical leadership at HHS could mean for a biotech built around mRNA.

Moderna also said it no longer expected to receive approval for its combination Covid/flu vaccine shot in older adults this year, noting that the FDA has confirmed it needs to submit efficacy data showing the shot reduces flu cases first. And it said it was “deprioritizing” developing the combination shot for younger adults.

It’s not clear if those moves are tied to the news that FDA political appointees have involved themselves in vaccine decisions. Moderna had already said in February it may need flu efficacy data from an ongoing trial before getting approval in older adults. Meanwhile, the commercial market for Covid vaccines among younger adults has collapsed and leadership was searching for ways to cut costs.

politics

Key GOP senators oppose Trump's research cuts

At a hearing yesterday, senators from both sides of the aisle rebuked the Trump administration over cuts to federally funded biomedical research. The critics included GOP Sen. Susan Collins, chair of the Appropriations Committee that funds the government, making her one most of the powerful Republicans to speak out against the cuts.

Collins singled out the administration’s effort to cap funding for indirect research costs at universities, saying that the plan violates the law. “These one-size-fits-all caps will be extremely harmful to many institutions,” she said.

Trump administration officials did not testify yesterday, but Collins said she plans to hold another hearing on this topic at which administration witnesses will appear.

science

NIH to reduce animal testing, following FDA

The NIH said it would reduce its reliance on animals in federally funded research and create a new office to develop the use of “non-animal approaches.”

The move follows the FDA's announcement last month to phase out requirements for drugmakers to perform animal testing, with the aim of lowering R&D costs and, eventually, the prices for prescription drugs.

Like the FDA, the NIH will turn toward AI and real-world data to model diseases and predict how drugs may perform. The NIH will also require grant review staff to participate in training to address “possible bias towards animal studies” and publicly report annual research spending to measure funding for animal studies.