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Cogent Biosciences Reports US FDA’s NDA Acceptance of Bezuclastinib for NonAdvanced Systemic Mastocytosis (NonAdvSM)

Shots: 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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Cogent Biosciences Reports US FDA’s NDA Submission of Bezuclastinib for NonAdvanced Systemic Mastocytosis

Shots: 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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Know Your Investor: Janus Henderson Group Plc (April’25 Edition)

Know Your Investor: Janus Henderson Group Plc (April’25 Edition)

Shots:    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…

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