Pharming Group N.V.’s new drug application for leniolisib in activated phosphoinositide 3-kinase δ syndrome has been accepted by the US Food and Drug Administration under a priority review, meaning the candidate could enter a vacant market early next year.
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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Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
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