Kolon TissueGene's TG-C, a cell and gene therapy for osteoarthritis, has recorded a significant drop in stock value following news of its failure to demonstrate efficacy in a Phase 3 clinical trial in the United States.
As of 9:14 a.m. on July 21, Kolon TissueGene's shares were trading at 42,900 won, down 18,300 won (29.90%) from the previous close, according to the Korea Exchange.
On the previous day, after the market closed, Kolon TissueGene announced the primary results of the first Phase 3 trial (TGC-15302) for TG-C.
The results indicated that TG-C did not achieve statistical significance compared to the placebo in all primary endpoints at the 12-month mark. This announcement marks the first of two Phase 3 trials conducted under the same conditions.
Kolon TissueGene CEO Noh Moon-jong stated, "We believe that a larger-than-expected placebo response in this first trial significantly impacted the interpretation of the results. We are currently conducting a comprehensive analysis of various factors, including the possibility of differences in responses by institution, as confirmed in additional analyses."
Based on these trial results, Kolon TissueGene plans to refine the development direction for TG-C. The company is expected to announce results from the second Phase 3 trial in the U.S. in October.
On the same day, Korea Investment & Securities downgraded its investment opinion on Kolon TissueGene from 'Buy' to 'Neutral' based on the failure of the U.S. Phase 3 trial.
* This article has been translated by AI.
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