Ono Pharma updates on two investigational drugs

9 October 2025

Ono Pharmaceutical (TYO: 4528) saw its shares rise 7.3% to 1,852 yen today, after the Japanese drug major announced encouraging new mid-stage data on two investigational medicines.

Ono revealed that that ONO-4578, an EP4 antagonist, in combination with Opdivo (nivolumab), an anti–PD-1 antibody and chemotherapy which is one of the standard treatments in this setting met the primary endpoint in the Phase II clinical trial in patients with previously untreated, HER2-negative unresectable advanced or recurrent gastric cancer (including gastroesophageal junction cancer).

In the trial, ONO-4578 in combination with Opdivo and chemotherapy demonstrated a statistically-significant prolongation of progression-free survival (PFS) compared with placebo in combination with Opdivo and chemotherapy. In addition, no new safety concerns were identified in the trial. Ono will publish the results at an upcoming academic meeting.

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