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04-Jun-2025

Nxera Pharma to Receive US$15 Million from Neurocrine Biosciences Following Dosing of First Patient in Phase 3 Trial of NBI-1117568

Tokyo, Japan and Cambridge, UK, 3 June 2025 – Nxera Pharma Co., Ltd. (“Nxera” or “the Company”; TSE 4565) today announces that its partner, Neurocrine Biosciences (“Neurocrine”) has dosed the first patient in its Phase 3 registrational program of NBI-1117568 (NBI-’568) as a potential treatment for schizophrenia, resulting in a payment of US$15 million to Nxera (Clinical Trial ID: NCT06963034). The US$15 million payment will be fully recognized as revenue in the second quarter of 2025.

Nxera previously announced the initiation of the Phase 3 registrational program of NBI-’568 by Neurocrine in May 2025. The Phase 3 study is a global double-blind, placebo-controlled trial evaluating NBI-’568 in adults with a primary diagnosis of schizophrenia who are experiencing an acute exacerbation or relapse of symptoms. The study is expected to enroll approximately 280 patients. The primary endpoint of the study is a reduction from baseline in the Positive and Negative Syndrome Scale (PANSS). The key secondary endpoint is improvement in the Clinical Global Impression of Severity (CGI-S) scale.

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Last Updated: 04-Jun-2025