Tonix Pharma Plans Regulatory Filings For Tonmya In Japan, China, US; Stock Up

(RTTNews) - Tonix Pharmaceuticals Holding Corp. (TNXP), Tuesday announced that it is planning for regulatory filings in Japan, China and the U.S., following the positive results from its clinical pharmacokinetic bridging study of Tonmya.

Tonmya, also known as TNX-102 SL, is used for the treatment of patients with fibromyalgia, which is a chronic disease causing pain and tenderness throughout the body.

"The results show a similar pharmacokinetic profile in ethnic Japanese and Chinese volunteers with a Caucasian comparator group," said Seth Lederman, chief executive officer of Tonix.

The company further stated that the recent study feedback along with positive results from Phase 3 RESILIENT study are sufficient to file for a Clinical Trial Notification or CTN in Japan and an Investigational New Drug or IND application in China.

Tonix also plans to file for a New Drug Application or NDA to the U.S. Food and Drug Administration in the second half of 2024 for the approval of Tonmya.

Currently, Tonix's stock is climbing 5.28 percent, to $0.36 on the Nasdaq.