Pharming’s Leniolisib On Track To Become First Disease-Modifying APDS Drug
Following NDA Acceptance
The Dutch firm’s US filing for its first-in-class PI3K inhibitor has been accepted under priority review, bringing the asset closer to becoming the first disease-modifying option for a rare, genetic disorder.
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The company sees leniolisib as a way to expand its US and global commercial footprint before bringing in additional rare disease assets.
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Leniolisib has become the first product to be granted accelerated assessment status by the European Medicines Agency this year.