February 3, 2026
elaine-chen-avatar-teal
National Biotech Reporter
Good morning. Did Pfizer overpay for the obesity biotech Metsera? It's probably still too early to tell, but we have some new data this morning.

The need-to-know this morning

  • Pfizer reported weight-loss results for a monthly GLP-1 obesity injection that it acquired as part of the $10 billion Metsera transaction. The pharma giant also reported fourth-quarter and 2025 earnings.
  • Merck's earnings report can be found here. 2026 guidance was slightly below Street consensus.

regulation

FDA wants long-term monitoring of autoimmune patients receiving CAR-T

The FDA is advising drug developers to study the long-term effects of using CAR-T to treat patients with autoimmune conditions, out of concern the therapies could cause cancer or fertility issues.

The recommendations, published in an op-ed yesterday in the Annals of Internal Medicine, align with standards for genetic therapies and CAR-T for cancers.

Interest among biotechs to study CAR-T as a treatment for lupus, myasthenia gravis, and other autoimmune conditions has exploded in recent years. While the FDA's new guidance is expected, some experts fear it could be too onerous for some biotechs. 

Read more from STAT's Allison DeAngelis.

health tech

An AI that renews prescriptions fuels debate on FDA regulation

Utah recently announced it will partner with startup called Doctronic, which has an AI bot to refill drug prescriptions without clinicians.

The technology, though, is not approved by the FDA. Instead, Utah is using it under a state program that lets companies test legally challenging ideas under its supervision.

The company doesn't believe its AI bot qualifies as a medical device that needs to be regulated by the FDA, but several legal and policy experts disputed that. More broadly, this example highlights experts' concern that as more AI medical tools flood the market, whether there will be sufficient regulation to ensure their quality and safety.

Read more from STAT's Mario Aguilar.

oncology

New study brings renewed attention to timing of immunotherapy

A new randomized trial published yesterday in Nature Medicine is reviving the theory that infusing immunotherapy in cancer patients in the morning may be better than the afternoon.

In the trial, advanced lung cancer patients who got chemo and immunotherapy infusions before 3 p.m. had a 60% reduction to the risk of progression compared to those who received infusions after 3 p.m.

Over the years, researchers over the years have published observations that align with this pattern. But many scientists, even those who published these observations, have been skeptical that time of day is truly an important factor.

Read more from STAT's Angus Chen.

More around STAT
Check out more exclusive coverage with a STAT+ subscription
Read premium in-depth biotech, pharma, policy, and life science coverage and analysis with all of our STAT+ articles.

More reads

  • From Croatia to MAHA: How an unapproved drug became the next hot peptide, STAT
  • As U.S. officials move to reduce animal testing in research, focus may shift to restrictions on imports, STAT
  • Acadia expects negative opinion from EU regulators for Rett syndrome treatment, Marketwatch 

Thanks for reading! Until next time,

Enjoying The Readout? Tell us about your experience
Continue reading the latest health & science news with the STAT app
Download on the App Store or get it on Google Play
STAT