Kolon TissueGene is once again showing a downward trend in early trading, failing to sustain the previous day's rebound. With uncertainty persisting over the results of the U.S. Phase 3 clinical trial for its osteoarthritis cell gene therapy 'TG-C,' short-term bargain hunters and selling pressure are clashing.

As of 9:30 a.m. on the 28th, Kolon TissueGene is trading at 14,800 won, down 1,110 won from the previous trading day. The decline stands at 6.98%, with a trading volume of approximately 1.96 million shares.

Recent stock price volatility has expanded significantly. Kolon TissueGene hit the lower limit on the 21st, falling 29.90% to 42,900 won, and dropped further to 30,050 won on the 22nd, down 29.95%. On the 23rd, it closed at 21,050 won, down 29.95%, marking three consecutive days of limit-down from the 21st. It then fell further to 15,000 won on the 24th, down 28.74%, deepening the losses.

On the 27th, the stock rebounded 6.07% to 15,910 won, rising for the first time in seven trading days, as perceptions of excessive declines and bargain-hunting inflows emerged. However, selling pressure resurfaced today, giving back some of those gains.

The key factor pressuring the stock price is the topline data from the first U.S. Phase 3 clinical trial of TG-C. While the TG-C treatment group showed pain relief and joint function improvement, the placebo group also demonstrated a greater-than-expected improvement, resulting in a failure to achieve statistical significance for the co-primary endpoints of VAS and WOMAC. VAS is an index evaluating the degree of pain perceived by the patient, and WOMAC is an assessment standard measuring joint pain, stiffness, and physical function.

The failure to meet the co-primary endpoints in a late-stage trial was perceived as a factor heightening uncertainty over the future approval strategy and commercialization timeline. However, the company explained that the safety results were consistent with previously observed TG-C trends. Detailed analyses are also underway to examine variations across clinical institutions, patient characteristics, and the causes behind the large placebo response.

The market is closely watching the topline data from the second U.S. Phase 3 trial and the subgroup analysis results from the first trial. Depending on how the efficacy indicators appear in the second trial, the development direction for TG-C and the consultation strategy with the U.S. Food and Drug Administration (FDA) may change.

Given that Kolon TissueGene's stock price has undergone three consecutive days of limit-down and an additional sharp decline, high volatility is likely to persist for the time being. Key variables to monitor going forward include the background behind the increased placebo response in the first trial, the results of the second trial, the company's subsequent development plans, and its financial position.

[This article was written with the assistance of AI. This article is an informational material based on securities firm reports and regulatory filings and does not recommend buying or selling any specific stock. Target prices and earnings forecasts may change depending on market conditions and the corporate management environment, so investment decisions and responsibilities lie with the investor.]