Otsuka HD (4578.T): First Take: Positive 2-year eGFR data for Voyxact; maintain Buy

Research evidence excerpt

Otsuka HD (4578.T): First Take: Positive 2-year eGFR data for Voyxact; maintain Buy

Equity Research

2 July 2026 | 11:25AM JST

Otsuka HD (4578.T): First Take: Positive 2-year eGFR data for Voyxact;

maintain Buy

Otsuka HD announced top-line results for the full study period (two years) of the Akinori Ueda, Ph.D.

+81(3)4587-9910 |

Phase 3 VISIONARY trial of its anti-APRIL antibody Voyxact (sibeprenlimab) for IgA akinori.ueda@gs.com

Goldman Sachs Japan Co., Ltd.

nephropathy on July 2 (link). Compared to placebo, the drug demonstrated

Tomo Taniguchi

statistically significant stabilization of eGFR (estimated glomerular filtration rate) as +81(3)4587-1071 |

well as an improvement in kidney function (a normal rate of annual kidney function tomo.taniguchi@gs.comGoldman Sachs Japan Co., Ltd.

decline is less than 1 mL/min/1.73 m²/year).

We view this as positive progress in line with our Buy thesis, as (1) the data suggest

results in line with our previous view (link) that the negative figure for the annualized

slope of eGFR could shrink compared to the 12-month data, and (2) we focus on the

potential for expectations of Voyxact becoming a blockbuster to rise through

disclosures such as eGFR data (link). Looking ahead for the drug, we will be watching

(1) the release of detailed results from the 2-year data of the VISIONARY trial (which

we expect at Kidney Week in October; link), (2) full approval and the launch of the

auto-injector in the US (potentially in 1H 2027) and potential treatment guideline

revisions, and (3) market trends following the launch of competing products (PDUFA

dates are July 7 for atacicept and November 30 for povetacicept).

Main points from Otsuka HD announcement

The main points from the company’s announcement of the top-line results for the