Otsuka Holdings (4578): Final Phase 3 analysis results for Voxyact exceeded expectations, a positive surprise

Research evidence excerpt

Otsuka Holdings (4578): Final Phase 3 analysis results for Voxyact exceeded expectations, a positive surprise

J P M O R G A N Asia Pacific Equity Research

02 July 2026

Otsuka Holdings (4578) Overweight

4578.T, 4578 JP

Final Phase 3 analysis results for Voyxact exceeded Price (01 Jul 26):¥10,665

expectations, a positive surprise Price Target (Dec-26):¥14,000

At 8:30 a.m. on July 2, Otsuka Holdings announced that topline results were Japan Equity Research

favorable at 24 months in the Phase 3 VISIONARY trial of Voyxact

Biotechnology & Pharmaceuticals/

(sibeprenlimab) for IgA nephropathy. Over two years, Voyxact showed a Medical Technologies & Services

statistically significantly stabilized estimated glomerular filtration rate (eGFR), an AC Seiji Wakao, Ph.D.

indicator of renal function, compared to placebo and demonstrated improvement

(81-3) 6736-8612

in renal function. Voyxact also achieved the rate of renal function decline at the seiji.wakao@jpmorgan.com

normal aging level targeted by KDIGO 2025 IgAN Guidelines. Yugo R. Kamimura, Ph.D.

(81-3) 6736-8635

The key takeaway is that renal function (eGFR) improved from baseline over two yugo.kamimura@jpmorgan.com

years and the annual decline in renal function was suppressed to a normal rate. In Naoko Saito

other words, the annualized eGFR slope likely improved to less than -1 mL/ (81-3) 6736-8693

min/1.73m2 per year. naoko.saito@jpmorgan.com

JPMorgan Securities Japan Co., Ltd.

In the interim analysis, the slope was -3 due to an initial increase in eGFR after

dosing, so few expected a result better than -1. We view the current results as a

positive surprise. At the time of the interim analysis, there were 227 patients (106

in the Voyxact group, 121 in the placebo group), while the final analysis included