Kolon TissueGene plunged to the lower limit simultaneously with the opening of the regular session on the 21st, triggering a volume surge circuit breaker (VI).

As of 9:02 a.m. on the same day, Kolon TissueGene was trading at 42,900 won, down 19.90% from the previous trading day, reaching the lower limit. It is the first time since November of last year that the stock has fallen below the 40,000 won level.

The direct cause of the sharp decline is the results of the U.S. Phase 3 clinical trial for 'TG-C,' a cell and gene therapy for osteoarthritis, which were disclosed after the market close the previous day. The results, which fell short of market expectations, are interpreted to have rapidly contracted investor sentiment.

◆ TG-C U.S. Phase 3 Fails to Demonstrate Significance in Primary Efficacy Endpoint

Through a public disclosure, Kolon TissueGene stated that TG-C failed to demonstrate statistically significant improvement over placebo in the co-primary efficacy endpoints at 12 months: the VAS pain score and the total WOMAC score.

However, the company explained that the 104-week safety analysis showed favorable overall safety and tolerability, with no new safety signals identified.

The company said on its website, "No clinically serious safety concerns were observed in this study, and we plan to conduct a thorough additional analysis of the detailed data."

It added, "Based on the analysis of the detailed data from the TG-C 15302 Study and the results of the TG-C 12301 Study, we will promptly review the optimal development pathway, including consultation with regulatory authorities."

◆ Future Clinical Results and FDA Consultation to Serve as Key Variables for Stock Price

The company stated that it plans to combine the results of another ongoing U.S. Phase 3 clinical trial with the current data to use as a basis for future consultation with the U.S. Food and Drug Administration (FDA).

"The TG-C 12301 Study, the remaining key study in the Phase 3 clinical program, is proceeding as planned without delay, and we intend to announce topline data in October 2026," it added. "We plan to establish TG-C's future development strategy by comprehensively analyzing the data from both studies."

The market had already reflected the shock after the previous day's disclosure, with Kolon's stock price falling to the price limit on the alternative trading system (NXT). Since Kolon TissueGene was not an NXT-eligible stock, investors' direct reactions are manifesting in the regular session today.

The future trajectory of the stock price is expected to be influenced by market assessment of additional clinical results and the FDA consultation process. As volatility is likely to persist for the time being, attention is focused on intraday supply and demand as well as subsequent disclosures.

[This article is for reference in making investment decisions, and the final responsibility for investments lies with the investor.]