Nxera Pharma Receives a Manufacturing Approval Partial Amendment Regarding the Addition of a Manufacturing Site in Asia for QUVIVIQ® 25 and 50 mg

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Tokyo, Japan and Cambridge and London, UK, 31 October 2025 – Nxera Pharma Co., Ltd. (“Nxera” or “the Company”; TSE 4565) announces that Nxera Pharma Japan Co., Ltd. (a wholly owned subsidiary of the Company) has received a manufacturing approval partial amendment with respect to QUVIVIQ® (daridorexant) 25 and 50 mg (“the Product”). Daridorexant was launched in Japan as QUVIVIQ® for the treatment of adults with chronic insomnia in December 2024, an application for approval has been submitted for regulatory review in Taiwan, and it is undergoing Phase 3 trials in South Korea.

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