Kolon TissueGene stocks hit the daily limit-down for three days from May 21 to May 23 after its arthritis drug failed a US Phase 3 trial. The stock closed at 21,050 won on May 23, down 29.95%, after trial TGC-15302 for TG-C treatment did not show statistical significance versus placebo in Visual Analog Scale and WOMAC endpoints. The stock fell 85.87% from its May 15 high of 149,000 won.
Kolon TissueGene Stocks Fall 85.87% from May Peak
Kolon TissueGene (KOSDAQ: 950160) traded at 21,050 won on May 23, down 29.95% from the previous trading day, according to Korea Exchange data. The stock remained at the daily limit-down for the third consecutive session on May 21, May 22, and May 23. The stock price reached 149,000 won on May 15 before entering a sharp decline, resulting in an 85.87% drop from that peak.
The company announced that its US Phase 3 trial TGC-15302 for TG-C (formerly Invossa) failed to demonstrate statistical significance versus placebo in the primary endpoints of Visual Analog Scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The company had originally planned to submit a Biologics License Application (BLA) in the first quarter of next year based on results from two US Phase 3 trials, but this timeline is now delayed.
Korea Investment & Securities Downgrades Rating to Neutral
Korea Investment & Securities adjusted its investment opinion on Kolon TissueGene from "Buy" to "Neutral" on May 21. The brokerage stated in its report that "unlike expectations, the results from past Korean Phase 3 and US Phase 2 trials were not reproduced in this Phase 3 trial" and analyzed that "the current stock price has limited upside potential relative to TG-C's fair value."
The brokerage noted in its report that "the possibility of success in the trial scheduled for October cannot be ruled out" and stated "it cannot be concluded that TG-C has no efficacy."
Company Maintains Drug Efficacy Consistent with Prior Trials
Kolon TissueGene stated that the drug efficacy of TG-C itself appeared consistent with previous clinical trials. The company established a policy to continue its regulatory strategy with the US FDA based on the results of the second US Phase 3 trial scheduled for announcement in October.
Jeon Seung-ho, co-CEO of Kolon TissueGene, answered questions at a press conference on TG-C US Phase 3 results held at Kolon One&Only Tower in Gangseo-gu, Seoul on May 21.
FAQ
Why did Kolon TissueGene stocks fall for three consecutive days?
The stock hit the daily limit-down on May 21, May 22, and May 23 after the company disclosed that its TG-C arthritis treatment failed to demonstrate statistical significance versus placebo in primary endpoints (VAS and WOMAC) in US Phase 3 trial TGC-15302.
What did Korea Investment & Securities say about Kolon TissueGene stocks on May 21?
Korea Investment & Securities downgraded its investment opinion from "Buy" to "Neutral" on May 21, stating that past Korean Phase 3 and US Phase 2 trial results were not reproduced in this Phase 3 trial and that the current stock price has limited upside potential relative to TG-C's fair value.
When will Kolon TissueGene announce its second US Phase 3 trial results?
The company stated it will announce the results of its second US Phase 3 trial in October and will continue its regulatory strategy with the US FDA based on those results.
