November 4, 2025

The need-to-know this morning

Pfizer reported third-quarter revenue of $16.7 billion, matching analysts' expectations, and adjusted earnings per share of $0.87, beating consensus. It narrowed its 2025 adjusted EPS guidance to to a range of $3.00 to $3.15 from $2.90 to $3.10.
More earnings from Vertex Pharma and Madrigal Pharma.

regulation

Scandal and controversy take toll on FDA credibility

Photo illustration: STAT; Photo: Adobe

The recent controversies surrounding the FDA have become part of a pattern of instability and upheaval that observers fear is undermining the agency's credibility and putting the health of Americans at risk.

In the past few days, the FDA put its top drug regulator, George Tidmarsh, on administrative leave after he was accused of using his regulatory authority to target a former business associate. He is also now openly assailing another top FDA official, Vinay Prasad. Yesterday, Uniqure, a biotech developing a closely watched gene therapy for Huntington’s disease, said the FDA changed its guidance around whether a recently conducted trial could provide the basis of approval for its treatment.

“What’s happening at the top of the FDA is embarrassing,” said a portfolio manager at a large biotech fund who asked not to be named. “How am I supposed to convince people, other investors, that this sector is doing important work when the leaders of the FDA are acting this way?”

Read more from STAT's Matt Herper and Lizzy Lawrence.

Earnings

Sarepta's dismal quarter marred by drug failures and a long list of excuses

A take from my colleague Adam Feuerstein: Sarepta Therapeutics delivered a disastrous third-quarter earnings performance. A long-delayed confirmatory clinical trial of two of the company’s drugs for Duchenne muscular dystrophy failed to show benefit for patients. Sales of its gene therapy were lower and the outlook for next quarter was downgraded. The company lost money again.

Investors looking for accountability from Sarepta’s executives were left wanting. What they got on last night’s conference call was a long list of excuses.

glp-1s

Telehealth firms advertise GLP-1 'microdoses' to continue compounding

A growing number of telehealth companies, including Noom, Found, and Hims & Hers, are offering “microdosed” GLP-1s.

Though doctors and researchers say there is no robust clinical evidence for giving the drugs at very small doses, these offerings will likely persist as a strategy for telehealth firms and their compounding pharmacy partners to continue to profit off of the popular drug class, STAT's Katie Palmer writes.

Telehealth companies began offering compounded GLP-1 products when the branded versions fell into shortage. They had to stop this year after the branded drugs came back into supply, but many firms have continued to offer compounded products by tweaking their formulations just enough, they argue, to be allowable under the FDA’s compounding guidance.

psychedelics

First psilocybin drug may be approved earlier than expected

Compass Pathways, which is developing a psilocybin treatment for severe depression, said this morning it now expects a potential approval decision in late 2026 or early 2027, nine to 12 months earlier than previously anticipated.

Following what it described as a “positive” meeting with the FDA, Compass is now planning for a rolling submission. If approved, its drug would be the first psilocybin therapy on the market.

Health Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary have both voiced support for the development of psychedelics, leading proponents to hope the agency will help get them on the market faster.

financing

Spinout from Doudna's lab raises $82 million

A new company spun out from the lab of researcher Jennifer Doudna has raised $82 million to create in vivo CAR-T treatments.

The startup, Azalea Therapeutics, quietly raised a $17 million seed round in 2023 and then closed $65 million in new Series A last week. It’s a notable raise amid a protracted downturn for gene-editing startups.

Today’s CAR-T therapies are highly effective at treating certain blood cancers, but patients’ cells have to be removed, re-engineered in a facility, and then reinfused — a toxic, expensive, and cumbersome process. That's why drug companies are intersted in creating in vivo alternatives that can transform patients’ cells in their body.

Read more from STAT's Jason Mast and Allison DeAngelis.

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