KOSDAQ-listed Kolon TissueGene was strong early on the 26th. Buying is seen as flocking to the stock on news that the announcement of the phase 3 results for Kolon TissueGene's knee osteoarthritis treatment is not far off.
As of 9:38 a.m. on the 26th, Kolon TissueGene was trading at 116,500 won on the KOSDAQ market, up 14,200 won (13.88%) from the previous trading day.
On the 26th, Wi Hae-ju, a researcher at Korea Investment & Securities Co., said the phase 3 trial of Kolon TissueGene's knee osteoarthritis treatment TG-C (formerly Invossa) 15302 is in its final stage. TG-C is a cell and gene therapy for osteoarthritis formerly known as Invossa.
The researcher said, "For the TG-C 15302 phase 3 trial, only the aggregation of data from the last patient to be dosed next month remains," adding, "a countdown to the topline (results of the key endpoints) announcement will begin soon along with the analysis of the results." The announcement is scheduled for early July.
The researcher also judged that the U.S. Food and Drug Administration's easing of chemistry, manufacturing and controls (CMC) regulations for cell and gene therapies is positive for TG-C's commercialization.
The researcher said, "In Jan., the U.S. Food and Drug Administration (FDA) eased CMC regulations for cell and gene therapies," adding, "indirect and direct benefits are also expected in the review for TG-C's product approval and its commercialization process."