Banning WuXi is more complicated than it might sound

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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.

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