Otsuka Holdings Co., Ltd.
Phase 3 results briefing for the IgA nephropathy treatment VOYXACT announced
In the Phase 3 (VISIONARY) trial of VOYXACT for IgA nephropathy, 2-year eGFR improvement and stabilization of kidney function were achieved. Progress on FDA sBLA review and preparations for filings in various countries were reported.
Key Figures
- VOYXACT: Phase 3 VISIONARY trial results favorable
- FDA sBLA review ongoing
- Continued filings in various countries toward approval
AI要約
News Overview
Otsuka Holdings, with its 100%-owned subsidiaries Otsuka Pharmaceutical and OPDC, announced that the phase 3 trial (VISIONARY) results for the IgA nephropathy drug voxycimremab (VOYXACT) were favorable for the full trial duration. The drug has already received expedited approval from the U.S. FDA in November 2025, and is in the review stage of the sBLA with the aim of obtaining the next approvals. Data showing long-term protection/improvement of kidney function support the potential to slow CKD progression. Further conference presentations and filings in other countries are planned.
Outlook and Impact
This progress is viewed as an important step toward medium- to long-term corporate value enhancement, with continued advancement of the FDA approval process. While direct impact on sales plans is not yet determined, VOYXACT is positioned as a growth driver, with anticipated market expansion through international approvals.
Otsuka Holdings Co., Ltd.
Company overview · Stock price · Financial data · All IR
