November 6, 2025

The need-to-know this morning

Moderna and AstraZeneca reported third-quarter earnings.
Johnson & Johnson won U.S. approval to sell the antipsychotic drug Caplyta as a treatment for depression, a major step in the drugmaker's efforts to make the medicine a blockbuster. Caplyta, acquired in J&J's $14.6 billion deal for Intra-Cellular Therapies earlier this year, is now cleared for the roughly 22 million people in the U.S. with major depressive disorder.

hair loss

Biotech's hair-raising bet on baldness

For a long time, biotech companies developing hair loss drugs have been the subject of disinterest among investors, and perhaps even mockery. No longer.

Startups Pelage Pharmaceuticals and Veradermics hauled in a combined $270 million last month to tackle androgenetic alopecia — the world's most common form of baldness — with bona fide science rather than "lotions and potions," as GV Executive Venture Partner Cathy Friedman told STAT's Allison DeAngelis.

Indeed, investors like GV and SR One are hoping companies selling hair loss treatments directly to consumers can cash in, not unlike what drugmakers have done with GLP-1 drugs. From Absci's AI-designed prolactin-blocking therapy to a new George Church venture, a once-derided category is now flush with capital, ambition, and the promise of turning vanity into biotech's next billion-dollar business.

"I don't think you can underestimate how much people want their hair," a dermatologist working with AbSci told STAT.

obesity

FTC raises concerns on Novo's offer for Metsera

The Federal Trade Commission is warning Novo Nordisk that its bid to outmaneuver Pfizer for obesity startup Metsera could violate merger law, citing concerns that Novo's two-step deal structure may skirt the Hart-Scott-Rodino Act's pre-merger review requirements, STAT's Elaine Chen and Ed Silverman write.

In a letter to Novo and Metsera, the FTC said the Danish drugmaker's plan to first buy half of Metsera's shares before seeking approval could allow anticompetitive harm before regulators weigh in. Pfizer, which has sued Novo twice since the start of the bidding war, has accused the pharma company of trying to neutralize a future rival. Novo insists its proposal complies with antitrust rules and that it's working "constructively" with the agency.

"The competitive concerns here are profound," said David Balto, a former FTC policy director. "The FTC will be extremely concerned about the competitive impact of the merger."

REGULATION

The FDA is a mess, but don't blame it for everything

So says STAT's Adam Feuerstein, in a new edition of Adam's Biotech Scorecard.

Biohaven Pharmaceuticals, he notes, is blaming FDA tumult for the agency's rejection of its treatment for spinocerebellar ataxia, a rare and debilitating neurodegenerative disease. But approval was never a sure thing, Adam says. The review was handled by the Division of Neurology I within the Office of Neuroscience, a group that has been stable, personnel-wise, even with all the FDA staff turnover.

Adam also has some questions about Uniqure's assertion that the FDA's new stance on its Huntington's therapy contradicted a previous agreement with the company.

RESeARCH

Judges skeptical of Trump's NIH overhead cuts

A federal appeals panel signaled doubts yesterday about the Trump administration's legal rationale for slashing NIH research overhead payments, STAT's Jonathan Wosen writes. It's a move that could strip universities of billions in funding for lab operations and infrastructure.

Judges in Boston questioned the government's claim that the dispute belonged in the U.S. Court of Federal Claims rather than under the Administrative Procedure Act. One judge called the NIH's 15% cap "a dramatically modified approach" to congressional limits.

The policy, now blocked by a lower court, has ignited a broad backlash from states and universities warning of catastrophic research slowdowns. Meanwhile, ongoing legislative and administrative efforts suggest the fight over indirect costs — and who pays to keep America's labs running — is far from over.

More around STAT