- The FDA has accepted for review BeiGene Ltd's BGNE supplemental marketing application for Brukinsa (zanubrutinib) for marginal zone lymphoma (MZL) and granted priority review.
- The application covers adult MZL patients who have received at least one prior anti-CD20-based therapy.
- The agency's target action date is September 19.
- Brukinsa is a small molecule inhibitor of Bruton's tyrosine kinase to treat various B-cell malignancies.
- Price Action: BGNE shares closed at $337.98 on Tuesday.
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