April 27, 2024

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[THE INVESTOR] SK Biopharmaceuticals said on March 28 it is speeding up the development of a sleep disorder treatment with plans to file an application with the US Food and Drug Administration this year.

The pharmaceutical unit of SK Group said its new drug candidate SKL-No5 has met its primary endpoint in the phase 3 clinical trials conducted on patients suffering from narcolepsy and sleep apnea. 

With the positive efficacy results, the firm will seek to file a New Drug Application at the FDA later this year.

In 2011, the company signed a deal with Jazz Pharmaceutical to grant it an exclusive worldwide license to develop and commercialize SKL-No5 with a therapeutic focus on treating sleep disorders.

SK holds sales rights for the medication in 12 Asian countries including China, Japan and Korea.

By Park Han-na (hnpark@heraldcorp.com)