November 19, 2025

The need-to-know this morning

Alkermes increased its takeout offer for Avadel Pharmaceuticals to $22.50 per share, topping a competing bid from Lundbeck.
Agios Pharmaceuticals reported mixed results from a Phase 3 study in sickle cell disease that will likely dim hopes of securing a U.S. approval for its drug.

GLP-1s

Novo nears release of high-stakes Alzheimer's data for semaglutide

Novo Nordisk is set to soon unveil pivotal Phase 3 data on whether semaglutide — the blockbuster GLP-1 drug behind Ozempic and Wegovy — can slow Alzheimer's progression. Expectations are muted, STAT's Elaine Chen writes, but success could reshape both the company's trajectory and the field.

Novo is also quietly staffing Alzheimer's-focused commercial roles as it prepares for any outcome.

The Evoke and Evoke Plus trials are testing whether GLP-1-driven neuro-inflammation reduction or improved brain insulin signaling can translate into preserved cognition. Even a smaller but significant effect would spark major scientific and commercial implications — though safety, especially unintended weight loss in non-obese patients, will be closely watched.

telehealth

Telehealth firms ride Novo's GLP-1 discount wave

Novo Nordisk's $199 cash discount for Ozempic and Wegovy has triggered a surge of telehealth marketing, with virtual-care platforms buying top Google ad slots to capture GLP-1-hungry patients before they reach the drugmaker's own site, STAT's Katie Palmer writes.

Companies like LifeMD, WeightWatchers, Ro, eMed, and GoodRx are integrating directly with NovoCare to streamline prescribing and fulfillment, — a win-win that boosts patient volume for telehealth firms and script volume for Novo.

The scramble underscores how much demand for GLP-1s is reshaping pharma's consumer strategy, pushing drugmakers to embrace third-party marketing channels that operate under looser advertising rules. But as branded telehealth providers battle ultra-cheap compounding competitors, researchers warn that patients may end up platform-hopping for the best deal amid a fragmented, lightly regulated ecosystem.

gene therapy

FDA stresses Elevidys heart risks in new label

The FDA has tightened its scrutiny of Sarepta Therapeutics' Duchenne gene therapy, Elevidys, highlighting an "acute, serious, and life-threatening" risk of myocarditis. The shift is forcing fresh attention on an important but largely overlooked cardiac risk, STAT's Jason Mast and Adam Feuerstein write.

The updated label comes amid a broader safety clampdown following two liver-failure deaths and new restrictions limiting use of the therapy to boys who can still walk — even as Sarepta insists no new data prompted the tougher wording.

Describing the elevated heart label as "very concerning," Mayo Clinic genetic cardiologist Mark Ackerman said "we're just not seeing this level of potential cardiac risk in any of the other gene therapies."

covid-19

Pandemic lawsuits gain steam under Trump

Covid-era legal challenges once considered long shots are advancing rapidly under the Trump administration, as HHS Secretary Robert F. Kennedy Jr. reshapes federal health policy and elevates vaccine skepticism into the mainstream.

While such lawsuits previously faced steep odds in court, attorneys aligned with Kennedy and other high-profile skeptics of vaccines are testing aggressive new strategies, STAT's Isabella Cueto reports. These range from False Claims Act cases targeting alleged underreporting of vaccine side effects to renewed attacks on employer mandates and state medical boards.

"The world just flipped," said Ohio-based attorney Warner Mendenhall, who has brought numerous Covid-related cases against hospitals, vaccine makers, and other companies. "I went from being a far outsider with no connection to the government, and now I've got friends all over the federal government."

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