FDA grants Priority Review to BRUKINSA with rituximab for mantle cell lymphoma
FROM THE WIRE · FINANCE.YAHOO.COM
If approved, BRUKINSA plus rituximab would be the first and only chemotherapy-free, BTK inhibitor-based regimen for adult patients with previously untreated mantle cell lymphoma Application supported by Phase 3 MANGROVE data, showing a 43% reduction in the risk of progression or…
Read at the source ↗MARKET IMPACTNEUTRAL✦ News Impact agent estimateTone: expected bullishPriority Review is a positive regulatory step for BeOne with a moderate stock impact.AI-generated summary
✦ IN BRIEF · AIAI-generated summary
- 01The FDA accepted and granted Priority Review to the BRUKINSA with rituximab sNDA.
- 02Phase 3 MANGROVE data show a 43% reduction in risk of progression or death.
- 03Full results will be presented at the ASH Annual Meeting.
NEWS IMPACT AND MARKET REACTIONChange from the reference price
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