December 22, 2025

The need-to-know this morning

AstraZeneca announced that a new Imfinzi combination failed to extend the lives of lung cancer patients. It also licensed a new KRAS inhibitor out of China for $100 million.

markets

VC Bruce Booth: IPO window poised to reopen

After two years of near stasis in the biotech IPO market, Atlas Venture partner Bruce Booth predicts a surge of new public offerings in 2026. He thinks there will be a sharp rebound in biotech stock performance and investors will have a renewed appetite for risk.

Clinical-stage companies have shown upward momentum, interest rates are improving, and there has been a rise in merger activity, Booth pointed out recently on "The Readout LOUD," STAT's biotech podcast. This is easing macroeconomic fears, and it offers some hope that the sector has turned a corner.

The lack of IPOs this year, he said, reflects timing rather than disinterest, with many companies only recently preparing filings and lining up bankers.

drug pricing

Drugmakers trade ingredients for tariff relief

Nine drugmakers on Friday unveiled deals with the Trump administration to lower the prices of some of their drugs, marking the administration's largest such deal to date.

Beyond that, some of these companies have agreed to donate bulk drug ingredients to a federal stockpile as part of Trump administration deals aimed at lowering U.S. drug prices, STAT's John Wilkerson writes.

Among the donations: Merck's antibiotic ertapenem, Bristol Myers Squibb's blood thinner apixaban, and GSK's albuterol. Key details remain unclear, including the size and value of the donations and whether companies will physically transfer ingredients or store them themselves, though experts note many manufacturers already hold months-long reserves.

Washington

FDA flashpoints to watch next year

The Food and Drug Administration is entering 2026 amid leadership churn, internal feuds, staff losses, and growing concern that politics are intruding on scientific decision-making, STAT's Lizzy Lawrence writes. Three issues, in particular, are concerning industry, regulators, and patients alike.

Can FDA Commissioner Marty Makary hold onto his post? His inner circle has taken an unusually hands-on role in drug and vaccine reviews, sidelining career scientists and potentially disrupting long-standing protocols.

Vaccine policy is incredibly vulnerable right now.

And questions swirl around how far the agency will push deregulatory changes in drug reviews, including an expedited voucher program and lower evidentiary standards that could invite political influence.

Read more on what Lizzy is thinking about as we head into 2026.

heart disease

Cytokinetics finally lands first FDA drug

After 27 years of research setbacks and near misses, Cytokinetics finally scored an FDA approval with its drug Myqorzo to treat obstructive hypertrophic cardiomyopathy, an inherited heart disease that limits blood flow. The drug will launch in late January and compete with Bristol Myers Squibb's blockbuster Camzyos, STAT's Adam Feuerstein writes.

While both drugs carry black box warnings for heart failure, Myqorzo's label allows dose adjustments rather than treatment interruption, which could offer it a commercial edge. Analysts expect sales to top $1 billion within three years, mirroring Camzyos' trajectory. Cytokinetics is preparing launches in Europe and China.

glp-1 drugs

Ozempic's Alzheimer's moment still matters

Novo Nordisk's highly anticipated EVOKE trials testing semaglutide in early Alzheimer's disease came up negative recently. But the results weren't entirely negative, opines Jason Karlawish, co-director of the Penn Memory Center at the University of Pennsylvania.

"There were signals, target engagement, ambiguous hints that the drug might influence biomarkers of dementia," he writes. "In a drug's journey from bench to bedside, this is a vital event. We might not be done with Ozempic for Alzheimer's."

Many unanswered questions about mechanism, targets, and prevention remain — and there's still an undercurrent of feeling, he says, that GLP-1 drugs may yet influence dementia risk, even if an Alzheimer's breakthrough hasn't yet come.

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