Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) trades at $1.31 on June 4, 2021, after ruling low at $0.97 on May 13, 2021. If it could cross $1.50, the stock could reach a high of $2.0 soon.
Tonix Pharmaceuticals achieved several significant achievements in 2020. It developed a pipeline of clinical-stage assets to treat immunological and CNS (central nervous system) diseases.
The company is debt-free and maintains a cash balance of $164.2 million at the end of Q1 2021. Tonix Pharmaceuticals is carrying out a double-blind, placebo-controlled, randomized, Phase 3 Rally clinical study to assess the efficacy and safety of TNX-102 SL in people suffering from FM (fibromyalgia).
Tonix Pharmaceuticals posted positive results from the RELIEF clinical trial in December 2020.
According to the communiqué, 5.6 mg TNX-102 SL demonstrated a significant reduction in pain compared to placebo at 14th week. The company expects to publish an interim analysis in Q3 2021.
Tonix Pharmaceuticals said TNX-102 SL achieved the primary objective in the phase 3 RELIEF clinical trial. The drug showed a significant reduction in daily pain than the placebo. 5.6 mg of the drug improved sleep quality as a secondary endpoint besides reducing fatigue and promoting functional recovery specific to fibromyalgia.
In the RELIEF clinical study, the patients showed improved tolerance to the drug. It is free from side effects like sexual dysfunction, nausea, insomnia, and weight gain compared to other approved drugs on the market to treat fibromyalgia.
Tonix Pharmaceuticals’ CEO, Seth Lederman, said Phase 3 RELIEF trial results validate the mechanism to promote sound sleep and prevent side effects observed in other approved therapies for fibromyalgia.
The substantial market opportunity for FM therapies
There is a significant market potential for the treatment of fibromyalgia. The FDA approved treatments for fibromyalgia in the market are Savella, Cymbalta, and Lyrica.
Cymbalta and Lyrica generated peak sales of $5 billion each to treat all indications. The treatments for fibromyalgia using these medicines are $1 billion each. Savella generated sales of $100 million. However, these three drugs come with undesirable side effects, and patients discontinued their use after 12 months.