Korea Exchange postpones decision on delisting Kolon TissueGene Results of Phase 3 clinical trial in U.S. likely to be key to resumption of stock trading
Translated by Kim So-in 공개 2022-02-10 08:06:25
이 기사는 2022년 02월 10일 08시01분 thebell에 표출된 기사입니다
The Korea Exchange (KRX), South Korea's bourse operator, has decided to postpone its decision on whether to delist the scandal-ridden drugmaker Kolon TissueGene from the secondary Kosdaq market.A Kosdaq market committee under the KRX decided on Monday to reopen the review meeting, without giving the reason and timeframe.
“We expect the patient dosing in the Phase 3 clinical trial in the U.S. will be completed in 2023,” said an official at Kolon TissueGene. “We have resumed patient dosing on December 28, 2021 despite the Covid-19 pandemic.”
Last year, Kolon TissueGene was given a one-year grace period by the Kosdaq committee for the second time to restore its credibility over phony reporting of its gene therapy drug Invossa and avoid delisting from the Kosdaq market. The trading of Kolon TissueGene stock has been suspended since 2019.
Upon the committee’s latest call, the final decision will be made in September or October, with the drugmaker’s submission of additional document.
Kolon TissueGene is required to submit an improvement plan and an expert’s verification on the plan within 15 business days from the expiry date of August 31. The KRX will hold a corporate review committee within 29 business days from the document submission date and make the final decision.
Whether the company will be delisted depends on the results of the Phase 3 clinical trial in the U.S. The key to the resumption of the trading is whether Kolon TissueGene can submit a statistically significant Phase 3 clinical trial interim results to the KRX. (Reporting by Sook Hong)
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