Sosei Heptares files NDA in Japan for daridorexant

31 October 2023

Shares Japanese drugmaker Sosei Heptares (TYO: 4565) rose 4% to 1,390 yen today, after it announced the submission of a New Drug Application (NDA) to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for the approval of daridorexant (ACT-541468).

The drug is a dual orexin receptor antagonist which has been co-developed with Mochida Pharmaceutical (TYO: 4534) for the treatment of adult patients with insomnia.

Sosei gained regional rights to daridorexant – marketed as Quviviq in the USA and Europe - when it acquired Swiss biotech Idorsia’s (SIX: IDIA) pharma business in Japan and Asia Pacific, excluding China, for around $470 million.

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