Brief: Otsuka Initiates Rolling Submission Of sBLA To FDA For Voyxact Traditional Approval
04/06/2026 19:42
BRIEF-Otsuka Initiates Rolling Submission Of sBLA To FDA For Voyxact Traditional Approval June 4 (Reuters) - Otsuka Holdings Co Ltd 4578.T:
OTSUKA PRESENTS POSITIVE INTERIM PHASE 3 VISIONARY EGFR DATA SHOWING VOYXACT (SIBEPRENLIMAB-SZSI) PRESERVED KIDNEY FUNCTION OVER 12 MONTHS IN IGAN
OTSUKA: INITIATED A ROLLING SUBMISSION OF A SUPPLEMENTAL BIOLOGICS LICENSE APPLICATION TO THE U.S. FDA FOR VOYXACT TRADITIONAL APPROVAL
OTSUKA: VOYXACT DEMONSTRATED INCREASE IN MEAN CHANGE FOR ESTIMATED GLOMERULAR FILTRATION RATE FROM BASELINE OF +0.7 ML/MIN/1.73 M(2)
Further company coverage: 4578.T
((Reuters.Briefs@thomsonreuters.com;))
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