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The US FDA has received NDA of bezuclastinib under the RTOR program for the treatment of pts with GIST who were previously treated with imatinib, backed by the P-III (PEAK) trial of bezuclastinib + sunitinib vs sunitinib monotx.
Trial met its 1EP of improved PFS by 50% (mPFS: 16.5 vs 9.2mos.) & showed ORR of…
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The US FDA has accepted the NDA of bezuclastinib for the treatment of NonAdvSM, with no advisory committee meeting planned or review issues identified yet (PDUFA: Dec 30, 2026)
NDA was backed by SUMMIT trial, which met its 1 & 2EPs, showing sustained, deepening clinical benefit through 48wks., plus impact on bone mineral density…
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The US FDA has received the NDA of bezuclastinib for the treatment of NonAdvanced Systemic Mastocytosis (NonAdvSM)
NDA was supported by the SUMMIT trial, which met its 1 & 2EPs, showing clinical benefit across all symptom domains, incl. 11 individual patient-reported symptoms as well as the most severe symptom, along with correlated biomarker reductions…
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Welcome to the 2025 series of Know Your Investor, featuring top venture capital firms focused on healthcare.
This edition highlights Janus Henderson Group Plc, a global investment firm managing approximately $378.7B in assets across Equities, Fixed Income, Multi-Asset, and Alternatives.
In 2024, the firm invested $5.36B across six funding rounds, adding 39 healthcare and…

