February 11, 2026

The need-to-know this morning

Madrigal Pharmaceuticals signed a deal with the Chinese biotech Suzhou Ribo Life Science, licensing six early-stage treatments for the liver disease MASH for $60 million up front and up to $4.4 billion in total.
Shares of Gilead Sciences fell after the company's forecast for 2026 sales and profits fell short of analysts' estimates.
Eli Lilly won Chinese approval for Omvoh, a treatment for inflammatory ‌bowel disease.

glp-1 drugs

Hims crackdown may signal broader reckoning ahead

Federal regulators and Novo Nordisk moved with unusual velocity after Hims & Hers announced plans to sell a compounded oral version of semaglutide: There were FDA warnings, a DOJ referral, and a Novo patent lawsuit. Hims' stock dropped 35%.

It might only be the start, STAT's Katie Palmer writes.

While compounded GLP-1s proliferated during drug shortages and lingered afterward, the Hims episode highlights regulators' growing unease with mass-marketed compounded drugs sold by national, vertically integrated telehealth platforms. There's concern around advertising, patent infringement, and the corporate practice of medicine.

The FDA has so far focused publicly on misleading marketing, but signs that it may scrutinize compounding practices themselves have the industry on edge, given how many telehealth companies rely on compounded versions of everything from acne treatments to libido drugs.

vaccines

FDA spurns Moderna flu vaccine with unusual Prasad missive

The FDA stunned Moderna yesterday by refusing to even review its application for a new mRNA flu vaccine, a rare and unusually public rebuke that is fueling fresh anxiety about the agency's regulatory posture under the Trump administration.

At issue is whether Moderna used the "right" comparator vaccine in its pivotal trial — a standard-dose flu shot rather than higher-dose products recommended for older individuals — despite FDA language previously telling the company that approach would be acceptable, STAT's Matthew Herper writes.

Moderna responded by releasing the "refusal-to-file" letter signed by biologics chief Vinay Prasad, which told the company that "your control arm does not reflect the best-available standard of care in the United States at the time of the study."

In a statement, CEO Stéphane Bancel said the decision "does not further our shared goal of enhancing America's leadership in developing innovative medicines," underscoring how blindsided the company felt.

drug pricing

There's PhRMA. There's BIO. And now there's MBAA.

As President Trump pushes to expand drug pricing policies beyond large pharmaceutical companies, a group of midsized biotechs has formed a new trade organization to avoid becoming collateral damage.

The newly created Midsized Biotech Alliance of America, made up of companies with one or two marketed drugs, argues that policies designed for pharma giants with sprawling portfolios could be existential for firms reliant on a single product. If midsized biotechs have to suddenly lower the price of just one product, they could be "wiped off the face of the earth," Richard Pops, CEO of Alkermes and chair of the new group, told STAT's Elaine Chen.

Unlike big drugmakers that can absorb selective price cuts, these biotechs warn that forced reductions — especially those tied to foreign price benchmarks they don't control — could be devastating. Tariffs, meanwhile, could further strain companies dependent on overseas manufacturing.

"Sometimes we think of the industry as monolithic and that we're all the same," Ardelyx CEO Mike Raab said. "We're not, because we're at all different stages of our evolution and development."

pipelines

Novartis prunes pipeline, doubles down on genetics

Novartis is sharpening its research strategy by cutting early-stage programs and prioritizing high-value medicines, biomedical research chief Fiona Marshall told STAT's Jonathan Wosen in an interview. It's a shift that the drugmaker says is necessary to stay competitive as science, markets, and geopolitics collide.

The company has recently dropped six early programs — following a larger pipeline cull in 2023 — while doubling down on genetic medicines, radioligand therapies, and cardiovascular drugs. This is supported by heavy investment in artificial intelligence and automation.

Speaking from San Diego, where Novartis is building a $1.1 billion research hub focused on gene and RNA-based therapies, Marshall defended the company's continued commitment to gene therapy for rare diseases.

rare disease

Compassionate use can leave rare disease families behind

The FDA's expanded access system for drug is failing the patients who need them most, opines Theron Odlaug, an operating partner at Signet Healthcare Partners — and a rare disease advocate whose grandchild has Dravet Syndrome. Children with such conditions are often excluded from clinical trials despite exhausting approved options, he says.

While U.S. regulators authorize the vast majority of compassionate use requests, drug companies often decline them for legitimate business, regulatory, and manufacturing reasons. This leaves families stuck in a paradox where promising therapies exist, but are inaccessible.

Odlaug says that regulatory safe harbors, review advantages, tax credits, and a little bit of limelight could incentivize companies to offer compassionate use without undermining innovation.

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