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Nxera Pharma’s Insomnia Drug Daridorexant Clears Key Phase 3 Hurdle in South Korea

Story Highlights
  • Nxera’s daridorexant met key efficacy and safety endpoints in a South Korean Phase 3 insomnia trial.
  • Positive data support a 2026 Korea filing and 2027 launch, expanding QUVIVIQ’s global market reach.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Nxera Pharma’s Insomnia Drug Daridorexant Clears Key Phase 3 Hurdle in South Korea

Meet Samuel – Your Personal Investing Prophet

Sosei Group ( (JP:4565) ) has provided an update.

Nxera Pharma reported positive top-line results from a Phase 3 trial in South Korea of its insomnia drug daridorexant 50 mg, showing statistically significant improvements over placebo in subjective total sleep time, time to fall asleep and wake after sleep onset, with a safety profile comparable to placebo. With insomnia affecting an estimated 6.5–11 million adults in South Korea and current treatment needs remaining high, the data clear a key regulatory hurdle and position Nxera to file for marketing authorization in early 2026 and potentially launch in 2027, extending the global footprint of QUVIVIQ and strengthening the company’s competitive position in the rapidly evolving insomnia treatment market.

The most recent analyst rating on (JP:4565) stock is a Hold with a Yen720.00 price target. To see the full list of analyst forecasts on Sosei Group stock, see the JP:4565 Stock Forecast page.

More about Sosei Group

Nxera Pharma Co., Ltd. is a Japan-based biopharmaceutical company listed on the Tokyo Stock Exchange (TSE 4565) that develops and commercializes innovative therapies, including the dual orexin receptor antagonist daridorexant for insomnia. The drug is already marketed as QUVIVIQ in Japan through a partnership with Shionogi and is sold by partners in the US, Canada, Europe, China and Hong Kong, underscoring Nxera’s focus on sleep medicine and its strategy of expanding the geographic reach of its pipeline across major global markets.

YTD Price Performance: -2.18%

Average Trading Volume: 945,589

Technical Sentiment Signal: Strong Sell

Current Market Cap: Yen73.21B

For detailed information about 4565 stock, go to TipRanks’ Stock Analysis page.

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