Official Meeting with the FDA Scheduled for Next Month
On the 27th, Naturecell's stock price showed strong performance, rising by over 9% during the trading session. The positive news that the company will hold an official meeting with the U.S. Food and Drug Administration (FDA) to discuss future strategies regarding the new drug Jointstem, which has been designated as a breakthrough therapy by the FDA, appears to have acted as a catalyst.
As of 10:36 a.m. that day, Naturecell's stock price recorded 29,050 KRW, up 9.01% compared to the previous day.
The designation of Jointstem, a stem cell therapy for severe degenerative arthritis developed by Naturecell, as a Breakthrough Therapy Designation (BTD) by the U.S. FDA seems to have been a positive factor. Jointstem also received the Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA in October last year. The FDA has requested Naturecell to provide related data concerning clinical development and manufacturing/production strategies. On the 17th of next month, the FDA plans to meet with Naturecell to discuss these matters.
Jointstem has demonstrated effects of regenerating cartilage, relieving pain, and delaying the decline of joint function for up to three years through a single local injection into the knee joint cavity.
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