On the 24th, Kolon TissueGene(950160) is plunging 24%. After news broke that a phase 3 clinical trial for an osteoarthritis treatment in the United States failed, it hit the lower limit (the bottom of the daily price limit range) for three straight days of transactions and is tumbling again today.
As of 9:16 a.m. on the 24th, Kolon TissueGene is trading on the KOSDAQ market at 15,980 won, down 5,070 won (24.09%) from the previous transaction day.
Previously, Kolon TissueGene closed at 61,200 won on the 20th, but after news of the clinical failure, the share price fell to the 16,000-won range in four days.
Kolon TissueGene announced the topline results of the phase 3 (TG-C 15302 Study) of TG-C conducted in the United States through a filing on the 20th. TG-C failed to achieve statistical significance versus placebo on 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, the U.S. phase 3 TGC12301 trial remains. If TGC12301 secures statistical significance versus placebo on both the VAS and WOMAC total score, Kolon TissueGene will be able to consult with the FDA on an approval strategy based on the result of "one success, 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 added, "We will closely analyze the cause of the stronger-than-expected placebo response and decide on the future approval strategy and commercialization direction."