February 4, 2026

The need-to-know this morning

There are pharma earnings, and then there are Eli Lilly earnings. The latter delivered the season's standout performance, highlighted by 2026 financial guidance that hurdled over Street consensus. Analysts noted that Lilly's strong forecast assuages concerns about pricing headwinds negatively impacting growth in the company's juggernaut obesity franchise, and stands in stark contrast to yesterday's sales warning from Novo Nordisk.
Novartis, GSK and Abbvie reported earnings, too.

exclusive

Trump officials blocked effort to speed review of Compass' psychedelic treatment

The FDA last year wanted to expedite the review of Compass Pathways' psilocybin treatment for severe depression as part of a new voucher program, but Trump administration officials vetoed the plan, STAT has learned.

The episode underscores the ways in which political pressure has shaped the program. For some advocates of psychedelic medicines, it also underlines an emerging disconnect between Health Secretary Robert F. Kennedy Jr., a vocal proponent of the psychedelics field, and other factions of the administration.

"The FDA, as much as they can, have been champions for this issue in moving it forward, giving it a fair shot," one advocate said. "I think that the White House has a lot politically to consider, especially going into the midterms later this year."

regulation

FDA leaders try to ease staff concerns about vouchers

Speaking of vouchers — at an employee town hall yesterday, FDA leaders tried to soothe staff concerns about the new voucher program, which has drawn criticism given the role political appointees have been given to influence with drug reviews.

FDA Commissioner Marty Makary pushed back on those worries, saying he launched the Commissioner's National Priority Voucher Program based on advice from his meetings with employees.

"If it were up to me, we'd remove the name 'commissioner' from the priority voucher program, because this is really an idea that came from you," Makary said.

Another top official said the program is "an effort to make our review processes patient-centric."

obesity

Novo sees lower sales and profits this year

Novo Nordisk yesterday said it expects sales and profits to decline this year, as it faces growing competition in the obesity market.

The company also said its negative outlook stems in part from the expiration of patents in some international markets and the agreement it struck with the White House last year to lower certain prices of its GLP-1 treatments.

Shares of Novo plummeted 15% yesterday. It was scheduled to report this morning, but released the results early.

Despite the negative forecast, the company reported a strong launch of the newly approved oral version of Wegovy, with demand driven by people buying the lowest starter dose through the company's direct-to-consumer offering.

obesity

Pfizer defends data on Metsera candidate

From my colleague Matt Herper: Yesterday, Pfizer released data on the monthly GLP-1 shot it acquired when it bought Metsera. Low and medium doses of the drug led to 10% and 12% weight loss at 28 weeks. Pfizer's stock fell more than 3% because investors expected more.

James List, Pfizer's chief internal medicine officer, emphasized that the middle dose was "pretty similar" to Eli Lilly's weekly drug Zepbound, and that less frequent dosing can have surprising advantages. It could mean that patients don't have to travel with needles (an airport hassle) and Pfizer's cost of goods is lower (perhaps that means a lower price?). He also said Pfizer is confident that a third, higher dose will lead to more efficacy without more nausea and vomiting and without making it much harder for patients to titrate up their dose.

Pfizer expects to bring the monthly GLP-1 to market in 2028, but List emphasized that beyond that "the possibilities are very, very large." He pointed to another Metsera compound that targets the amylin hormone, and to other prospects including a pill Pfizer licensed from YaoPharma, a Chinese firm, in December.

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