October 30, 2025

The need-to-know this morning

A new drug-sales king has been crowned. Eli Lilly's diabetes and weight-loss drug tirzepatide, marketed under the Mounjaro and Zepbound brand names, delivered $10.1 billion in third-quarter sales. Tirzepatide's quarterly sales surpassed the $8.1 billion in sales from Merck's cancer immunotherapy blockbuster Keytruda for the first time.
More earnings from Bristol Myers Squibb, Biogen, Insmed, Apellis, and Astellas.

exclusive

Moderna's mRNA empire stumbles amid politics, retrenchment

Once seemingly on top of the world, Moderna now faces a brutal reset.

Covid vaccine sales have cratered, the federal government cancelled $766 million in contracts, and the company's market cap has plunged around 90% from its 2021 peak to about $10 billion. But in a new exclusive, STAT's Jason Mast points out there have been other factors behind the slide: sprawling, costly bets on mRNA, troubled commercial execution, delays and disappointments beyond Covid, and morale-sapping cuts after years of hypergrowth.

Leadership quietly explored a sizable deal as Wall Street has demanded discipline. The broader mRNA dream is far from dead — but for Moderna, scale, politics, and proof are now the test.

M&A

Novo, Pfizer in bidding war for obesity-focused Metsera

We have M&A drama. This morning, Novo Nordisk said it had made a hostile $6 billion offer for Metsera Therapeutics, seeking to wrest the weight-loss drug developer away from Pfizer, which in late September had reached an agreement to buy it for $4.9 billion.

Novo, once the pacesetter in the white-hot obesity drug market, has started to lag behind in sales of approved drugs versus rival Eli Lilly. A host of other companies are also aiming to bring next-generation weight loss treatments onto the market in the coming years.

For Pfizer, the acquisition of Metsera and the biotech's range of experimental weight loss medicines was seen as a way for it to regain a toehold in the race, after its own development plans stalled out.

In a statement, Pfizer called Novo's move "reckless and unprecedented," arguing it was "an attempt by a company with a dominant market position to suppress competition in violation of law by taking over an emerging American challenger."

heart disease

Alnylam raises guidance as sales of heart drug match expectations

From STAT's Elaine Chen: Alnylam Pharmaceuticals said this morning that its drug Amvuttra, which was recently approved to treat a heart condition, brought in $685 million in sales in the third quarter, slightly more than the $625 million predicted by analysts polled by Visible Alpha.

The company also said patient demand of Amvuttra, which treats transthyretin amyloid cardiomyopathy, approximately doubled in the third quarter from the second quarter.

Analysts predicted Alnylam would report $0.5 earnings per share, but the biotech did not yet reach profitability in the third quarter. CEO Yvonne Greenstreet said in an interview, though, that the company is still on track to reach its stated guidance of achieving profitability for the year.

The company also raised its full-year revenue guidance by 10% at the midpoint to a range of $2.95 billion to $3.05 billion.

Amvuttra, an injection given every three months, is an RNA-interference drug that aims to silence messenger RNA involved in the production of an unstable protein involved in the disease. It competes against an older drug from Pfizer and a new treatment from BridgeBio, which are pills designed to stabilize the unstable proteins.

biosimilars

Trump plan seeks to fast-track cheaper biosimilars

The Trump administration yesterday unveiled a draft framework to accelerate the FDA approval of biosimilars — lower-cost copies of complex biologic drugs — by easing clinical requirements and speeding reviews. FDA Commissioner Marty Makary said the policy could triple approvals compared with recent years and make more biosimilars interchangeable at pharmacies.

Health secretary Robert F. Kennedy Jr., announcing the plan alongside Makary and CMS head Mehmet Oz, called it part of a broader effort to cut drug prices. Industry experts warned that while streamlining regulation may help, patent battles and opaque pharma deals could still stall savings for patients.

MDMA

FDA's psychedelic pause marks a scientific reset

The FDA's rejection of Lykos Therapeutics' MDMA-assisted therapy for PTSD isn't the death knell for psychedelic medicine — it's a demand for better science, regulatory strategy adviser Jama Pitman argues in a new First Opinion.

The agency's complete response letter cited basic trial flaws: missing safety data, poor long-term follow-up, and unblinded participants. Those issues would doom any drug, psychedelic or not, Pitman points out.

She says this moment should strengthen — not weaken — the field, urging rigorous study design, full transparency, and durability data to prove psychedelics' therapeutic value. With hundreds of trials underway and new investment flowing, the path forward is clearer: meet the standards, earn the trust, and build the evidence.