Nxera Pharma Co., Ltd. (SOLTF) announced on Wednesday that it has submitted a marketing authorization application to South Korea's Ministry of Food and Drug Safety for daridorexant, a dual orexin receptor antagonist for adult patients with insomnia.
The filing follows positive results from a Phase 3 trial in South Korea, where daridorexant met both primary and secondary endpoints, significantly improving subjective total sleep time, sleep onset latency and wake after sleep onset at Day 28 compared with placebo. Treatment-emergent adverse events were comparable between daridorexant and placebo.
Daridorexant is approved and marketed in Japan as QUVIVIQ. Nxera expects potential approval in South Korea in 2027.
SOLTF is currently trading at $5.44 on the OTC Markets.
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