On the 21st in early trading, Kolon Group plunged straight to the lower limit. Investor sentiment appeared to freeze on news that TG-C, an osteoarthritis cell and gene therapy that Kolon Group has developed for 27 years, failed in a phase 3 clinical trial in the United States.
At 9:12 a.m. that day, Kolon TissueGene(950160) was trading at 42,900 won, down 18,300 won (29.9%) from the previous session, and Kolon Life Science(102940) was trading at 21,100 won, down 9,000 won (29.9%). Kolon(002020) was also trading at 23,050 won, down 9,850 won (29.94%).
Kolon TissueGene on the 20th announced topline results from the U.S. phase 3 trial (TG-G 15302 Study) of TG-C through a filing. TG-C failed to achieve statistical significance over placebo for both the primary endpoints—the visual analog scale (VAS) pain score at 12 months and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score.
However, in long-term follow-up safety assessments, no new concern signals were identified, and the company plans to discuss the future development path with the U.S. Food and Drug Administration (FDA) based on additional clinical results.
Meanwhile, Kolon TissueGene plans to hold a press briefing at 10 a.m. that day at the Kolon One&Only Tower in Gangseo District, Seoul, to provide a detailed explanation of the U.S. phase 3 results for TG-C.