Kolon (002020) plunged to its limit-down price in after-hours trading on the alternative trading platform NXT (Nextrade) following the close of the regular session. The market attributes the decline to the after-hours disclosure of clinical Phase 3 results from its subsidiary, Kolon TissueGene.

As of 5:18 p.m. on the 20th, Kolon was trading at 23,700 won on NXT, down 10,150 won (29.99%) from the previous trading day, hitting the price limit. During the regular session on the Korea Exchange that day, the stock closed at 32,900 won, down 950 won (2.81%) from the prior day, but a concentration of sell orders after hours pushed it to the limit-down price on NXT.

The market's focus is on the after-hours disclosure from Kolon TissueGene. The company announced that its cell and gene therapy TG-C for osteoarthritis failed to meet the co-primary efficacy endpoints in topline data from the U.S. FDA Phase 3 clinical trial (TG-G15302 Study). It was unable to demonstrate statistically significant improvement compared to placebo in both the VAS pain score and the total WOMAC score.

However, the 104-week safety assessment revealed no new safety signals, and overall safety and tolerability were found to be favorable. The company stated that it plans to comprehensively review these results along with the outcomes of another ongoing U.S. Phase 3 trial before holding discussions with the FDA.

The disclosure also included investment cautionary notes. The probability of a clinical trial drug receiving final approval as a commercial product is widely known to be statistically around 10%, and if results during the clinical trial or product approval process fall short of expectations, commercialization plans may be altered or discontinued.

Meanwhile, Kolon TissueGene is not listed as an eligible stock for NXT after-hours trading, so its direct price reaction in the post-close market cannot be observed. Accordingly, investors are closely watching how Kolon TissueGene's stock price will reflect these clinical results during the regular trading session on the 21st.

[This article is provided as reference material for investment decisions, and the ultimate responsibility for investment lies with the investor.]