Tonix obtains positive results for its TNX-102 SL 5.6 mg Dose in pain reduction over placebo after a testing time of 14 weeks.
Shares of Tonix Pharmaceuticals Holding Corp. (TNXP) are rallying today after the company announced high-end top results for TNX-102 SL in its final phase 3 RELIEF study. The stock is surging with high volume as investors welcome these results as a potential opportunity for the company.
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TNXP stock has surged from the prior close of $0.63 to $0.91 up by almost 45%, as we write this at 9:48 A.M. EST. The trading volume is up by 108 million compared to the average volume of 5.8 million.
The biopharmaceutical company obtained the pre-defined primary endpoint which showed that TNX-102 SL is significantly helpful in reducing daily pain in fibromyalgia patients compared to placebo.
TNX-102 SL is a novel, non-opioidthat is being developed for the fibromyalgia community. It was examined in the Phase 3 RELIEF which was a 14-week randomized and placebo-controlled trial of TNX-102 SL with a dose quantity of 5.6 mg. The study featured 503 participants with fibromyalgia from 39 different sites in the U.S.
The clinical trials were conducted among the fibromyalgia participants which were given one table of TNX-102 SL (2.8 mg) for the first two weeks. Following that, the dose was lifted to two (5.6 mg) for the rest of the 12 weeks.
The company is highly committed to improving the lives of millions who suffer from fibromyalgia, with 90% of the patients being female. This study brings new hope for people who face severe pain every single day.
TNX-102 SL showed statistically significant results at 5.6 mg dosage and strong improvement in key secondary endpoints such as reducing fatigue and sleeplessness.
It wasn’t easy for Tonix to obtain a balanced result and this occasionally happens in drug development. The company was able to record consistent outcomes on both primary and secondary endpoints. Moreover, TNX-102 SL 5.6 mg was found tolerable in the RELIEF study.
The current results open ways for long-term safety exposure data. Upon following strong results, Tonix intends to submit a New Drug Application (NDA) for TNX-102 SL to the FDA in 2022.
Looking forward to the second potential pivotal Phase 3 study, the company expects to report the full top-line results in the second half of 2021. This will lead Tonix’s TNX-102 SL to manufacture the medicine for commercial deliveries anticipated in 2022 across the U.S.