On the 23rd, Kolon TissueGene(950160) went straight to the lower limit (the bottom of the daily price band). On the back of news that its arthritis treatment failed in phase 3 clinical trials in the United States, it is being transacted at the lower limit for three consecutive days.
As of 9:16 a.m. that day, Kolon TissueGene was being transacted on the KOSDAQ market at 210,50 won, down 9,000 won (29.95%) from the previous transaction day. Kolon TissueGene shares have been transacted at the lower limit for three straight days, dropping from the 60,000-won range to the 20,000-won range.
Kolon TissueGene on the 20th announced through a filing the topline results of the TG-C phase 3 clinical trial (TG-C 15302 Study) conducted in the United States. TG-C failed to secure statistical significance versus placebo for both the primary endpoint of the visual analog scale (VAS) pain score at 12 months and the Western Ontario and McMaster Universities osteoarthritis index (WOMAC) total score.
However, the U.S. phase 3 TGC12301 trial remains. If TGC12301 secures statistical significance versus placebo for both the pain index (VAS) and the WOMAC total score, Kolon TissueGene will be able to consult with the FDA on an approval strategy based on the result of "one success and one failure."
Jeon Seung-ho, co-CEO of Kolon TissueGene, said at a press briefing, "I think it is a half success, neither a success nor a failure," and noted, "We will closely analyze the cause of the larger-than-expected placebo response and decide on the future approval strategy and commercialization direction."