Is a contrarian leader good for the FDA?

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Morning. Today, we have the highly anticipated CagriSema results. We also see Ionis win approval for a new drug, which means it will start bringing its commercialization efforts in-house. And the FDA says tirzepatide is no longer in shortage.

The need-to-know this morning

• Applied Therapeutics said its embattled CEO Shoshana Shendelman resigned and was replaced on an interim basis by current CFO Les Funtleyder. The company also withdrew its European marketing application for the rare-disease drug govorestat. The FDA rejected the drug earlier this month.

Novo’s CagriSema disappoints in pivotal trial

The long-awaited CagriSema results are here.

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