Banning WuXi is more complicated than it might sound

Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox.

Hello, everyone. Damian here with a curious case before the FDA, a State of the Union preview, and the latest IPO to test biotech’s recent resurgence.

The need-to-know this morning

• Novo Nordisk’s experimental oral GLP-1 drug, amycretin, delivered promising early results, leading to a 13.1% loss of body weight in a 12-week study without notable new side effects. That compares to a 14.7% weight reduction for Eli Lilly’s oral GLP-1, orforglipron, in a Phase 2 study that lasted 36 weeks and a 5% reduction in weight in a 12-week study for Structure Therapeutics’ entrant. Current GLP-1s, which are the most in-demand class of medicines to emerge in years, are injections. Creating oral drugs could dramatically expand an already large market.

The next test of FDA flexibility

It belongs to Applied Therapeutics, whose lead drug, for the rare disease galactosemia, is up for an FDA decision based on a study that didn’t meet its primary endpoint but, according to the company, showed enough promise to merit approval.

STAT+ Exclusive Story

Already have an account? Log in

This article is exclusive to STAT+ subscribers

Unlock this article — plus in-depth analysis, newsletters, premium events, and networking platform access.

Already have an account? Log in

Already have an account? Log in

Individual plans

Group plans

Monthly

$39

Totals $468 per year

$39/month Get Started

Totals $468 per year

Starter

$30

for 3 months, then $39/month

$30 for 3 months Get Started

Then $39/month

Annual

$399

Save 15%

$399/year Get Started

Save 15%

11+ Users

Custom

Savings start at 25%!

Request A Quote Request A Quote

Savings start at 25%!

2-10 Users

$300

Annually per user

$300/year Get Started

$300 Annually per user

View All Plans

Get unlimited access to award-winning journalism and exclusive events.

Subscribe

Log In