February 18, 2026

FDA to Moderna: Never mind

That didn't take long. Moderna said this morning that the FDA will now review its experimental mRNA flu vaccine, reversing its decision denying a review because of a dispute over the vaccine's clinical trial design.

Expect attention now to turn toward Vinay Prasad, the FDA's top vaccine regulator, who overruled his own staff recommendation to block the Moderna vaccine review. Now, it seems, Prasad has been overruled.

“We appreciate the FDA’s engagement in a constructive … meeting and its agreement to advance our application for review,” said Stéphane Bancel, Moderna’s chief executive officer of Moderna, in a statement.

Read more from my colleague Lizzy Lawrence. And stay tuned for further twists and turns, because this story is far from over.

alzheimer's

Startup raises $175 million to study shuttled anti-amyloid antibody

A new company called Korsana Biosciences launched today focused on an Alzheimer's treatment designed to break down amyloid plaques in the brain.

Similar to a therapy Roche is developing, Korsana's candidate is designed to be carried to the brain through a “brain shuttle” that's posited to help make the treatment safer than anti-amyloid drugs already on the market.

The Alzheimer's field continues to debate whether researchers should still be focused on developing amyloid-targeting therapies. Korsana has at least convinced investors that it's a worthy target, having raised $175 million from some high-profile investors.

Read more from STAT's Allison DeAngelis.

GLP-1s

Lilly says Zepbound/Taltz combo helped treat psoriasis

Eli Lilly said this morning that, in an open-label Phase 3 study, its obesity drug Zepbound combined with its immunology treatment Taltz helped obese patients with plaque psoriasis more than Taltz alone.

However, much like in an earlier study testing the two drugs in psoriatic arthritis, it's not clear if the results will significantly affect prescribing patterns. Zepbound is already highly sought after for its weight loss efficacy. And as for Taltz, doctors have several other similar immunology drugs to choose from, such as UCB’s Bimzelx and AbbVie’s Skyrizi.

In the study, 27% of patients taking the combination achieved the primary endpoint of complete skin clearance and greater than 10% weight loss, compared with 6% of patients taking Taltz alone. It's notable Lilly chose this endpoint, since Taltz doesn’t cause weight loss, so it's not expected that many patients taking the drug alone would meet the endpoint.

Additionally, 40% of patients on the combination treatment experienced full skin clearance, compared with 29% of those taking Taltz.

politics

Makary and Oz greeted with opposite tones at PhRMA event

At a forum hosted by industry group PhRMA yesterday, CMS Administrator Mehmet Oz had a friendly on-stage conversation with industry leaders, while FDA Commissioner Marty Makary was grilled by a reporter about the agency's approach to vaccines.

The contrast highlights the industry’s positive relationship with Oz, who played a key role in negotiating drug-pricing deals between companies and the White House, and its more tenuous relationship with Makary, whose agency has been accused of weakening the U.S. vaccine enterprise and creating uncertainty for drugmakers.

Read more from STAT's Lizzy Lawrence and Daniel Payne.

psychedelics

Investors cheer Compass' psilocybin data

Investors viewed Compass' psilocybin data yesterday extremely positively, sending shares up over 30%. The company also said it's raising $150 million.

The data from two trials, which showed that Compass' drug led to statistically significant benefits for patients with treatment-resistant depression, likely meet the bar for approval, and investors are now looking ahead to the drug's launch.

vTFET-compass-shares-soar-on-psilocybin-data-

Many antidepressants have done well commercially even with some failed studies, and Compass stands out for having positive data across its Phase 3 program, Stifel analyst Paul Matteis noted.

Analysts see Compass' treatment, called COMP360, as having an edge over the therapy that would be its main competitor on the market, Johnson & Johnson's ketamine-based Spravato. Spravato requires chronic biweekly and or weekly dosing, while Compass has shown its drug can be effective with much less frequent dosing.

Cantor Fitzgerald analyst Josh Schimmer wrote that he sees COMP360 reaching $1 billion to $2 billion in peak sales for treatment-resistant depression. Compass also plans to develop its treatment in post-traumatic stress disorder, and Schimmer sees the drug reaching $3 billion to $5 billion in that indication.

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