Otsuka, JP3188220002

what it means for Otsuka Holdings stock

Published on 10/13/2026 at 05:36 | Editorial responsibility: Rafael Müller, Editor-in-Chief AD HOC NEWS

Otsuka filed the VOYXACT application on October 6, 2026. For Otsuka Holdings stock, revenue rose 17.41 percent to JPY 702.05 billion.

Otsuka Holdings completed a US filing for full approval of VOYXACT on October 6, 2026.
Second-quarter 2026 revenue reached JPY 702.05 billion, up 17.41 percent year over year.
UBS maintained a Buy rating and set a JPY 15,000 target on October 6, 2026.
The next reported event is scheduled for October 30, 2026, with a third-quarter earnings release.

Otsuka, JP3188220002, Illustration mit AI erstellt.

Otsuka Holdings (ISIN JP3188220002) completed a US filing for full approval of VOYXACT on October 6, 2026, giving the kidney-disease therapy a new regulatory milestone. Tokyo Brief reported that the companys US subsidiary completed the rolling submission for a supplemental biologics license application.

Three milestones shape the pipeline

On September 14, 2026, an Otsuka lung-cancer program delivered a median six-month progression-free-survival benefit in a late-stage trial, according to MarketScreener.

On October 2, 2026, Otsuka began a regulatory submission for zipalertinib, with completion expected by the end of 2026. Japan IR said the program had no change to consolidated earnings guidance for the fiscal year ending December 2026.

The October 6 VOYXACT filing is the latest of the three milestones. It represents a regulatory step before an approval decision, so the commercial value still depends on the FDA review and later adoption in clinical practice.

What does VOYXACT mean for growth

Otsuka Holdings reported second-quarter 2026 revenue of JPY 702.05 billion, up 17.41 percent from JPY 597.93 billion a year earlier, while net income rose to JPY 117.26 billion from JPY 88.53 billion. Those figures give the filing an operating backdrop beyond the pipeline narrative, according to IT Boltwise.

The same report said UBS maintained a Buy rating and set a 12-month target of JPY 15,000 on October 6, 2026. UBS also estimated potential annual uRDN revenue of JPY 100 billion to JPY 200 billion after reimbursement begins in January 2028, placing regulatory timing at the center of the longer-term thesis.

Next dates put execution on test

The next scheduled reporting date is October 30, 2026, for Otsuka Holdings third-quarter results, according to MarketScreener. A separate regulatory date cited by Japan IR is February 27, 2027, the target FDA review date for the zipalertinib program.

The last Lang & Schwarz quote was EUR 66.00 on October 12, 2026 at 11:00 p.m. CEST. The Tokyo Stock Exchange listing closed at JPY 11,665.00 on October 9, 2026, according to dated market data for ticker 4578.T.

The further course of trading is shown by the continuously updated real-time quote of Otsuka Holdings stock.