[Featured Stock] Kolon Life Science Hits Upper Limit on News of 'Invossa' Clinical Trial Resumption in the US View original image

[Asia Economy Reporter Eunmo Koo] Kolon Life Science is experiencing a sharp rise. The news that the clinical trials of the osteoarthritis gene therapy 'Invossa K Injection (Invossa)' in the United States are resuming seems to be influencing this trend.


As of 9:15 AM on the 13th, Kolon Life Science was trading at 26,900 KRW, up 29.95% (6,200 KRW) compared to the previous trading day.


Kolon Life Science announced on the 12th that the U.S. Food and Drug Administration (FDA) lifted the clinical hold on Invossa's Phase 3 clinical trial in the U.S. on the 11th and decided to resume the Phase 3 trial. Kolon Life Science is responsible for the domestic development and sales of Invossa, while Kolon TissueGene handles its development in the U.S. Accordingly, Kolon TissueGene will be able to resume clinical trials after about 11 months.



Previously, the Ministry of Food and Drug Safety canceled the product approval domestically after it was revealed that the cartilage cells listed in Kolon Life Science's approval application for Invossa were actually kidney cells. Subsequently, the U.S. FDA notified the suspension of the Phase 3 clinical trial in May last year due to changes in Invossa's components, putting Invossa's future in an uncertain situation.


This content was produced with the assistance of AI translation services.

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