Otsuka Holdings (4578): FDA announces accelerated approval of atacicept (TRUTAKNA); expect limited impact on VOYXACT

研报英文原文证据摘录

Otsuka Holdings (4578): FDA announces accelerated approval of atacicept (TRUTAKNA); expect limited impact on VOYXACT

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

08 July 2026

Otsuka Holdings (4578) Overweight

4578.T, 4578 JP

FDA announces accelerated approval of atacicept Price (07 Jul 26):¥11,515

(TRUTAKNA); expect limited impact on VOYXACT Price Target (Dec-26):¥14,000

On July 7, the FDA granted accelerated approval for Vera Therapeutics’s (covered Japan Equity Research

by Anupam Rama) atacicept (brand name: TRUTAKNA) for the indication of

Biotechnology & Pharmaceuticals/

reducing proteinuria in adults with primary IgA nephropathy (IgAN) at risk for Medical Technologies & Services

disease progression. We do not see anything in the labeling likely to significantly AC Seiji Wakao, Ph.D.

change the competitive environment with VOYXACT. The annual treatment cost

(81-3) 6736-8612

based on wholesale acquisition cost (WAC) for TRUTAKNA is $425,000, which seiji.wakao@jpmorgan.com

is higher than that for VOYXACT (approximately $360,000-390,000). Although Yugo R. Kamimura, Ph.D.

anti-drug antibodies (ADA) were observed in a certain percentage of patients, there (81-3) 6736-8635

were no clinically significant effects on efficacy or other factors, and this was not yugo.kamimura@jpmorgan.com

included as a precaution in the labeling. Naoko Saito

(81-3) 6736-8693

The higher price for TRUTAKNA compared with VOYXACT may partly reflect naoko.saito@jpmorgan.com

the once-weekly auto-injector formulation. As such, we think that a price premium JPMorgan Securities Japan Co., Ltd.

may be applied to the VOYXACT auto-injectors currently under development

compared with the existing prefilled syringe formulation.

Regarding ADA, a pooled analysis of Phase 2 and 3 clinical data showed 43.2%