Tonmya is the first FDA-approved therapy for the treatment of fibromyalgia in over 15 years, Tonix said.
Shares of Tonix Pharmaceuticals Holding Corp. (TNXP) jumped 4% in the pre-market session on Monday after its drug Tonmya received the U.S. Food and Drug Administration’s (FDA) approval for the treatment of fibromyalgia in adults.
Fibromyalgia is a chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system. Fibromyalgia afflicts an estimated 10 million adults in the U.S., mostly women, and symptoms include chronic widespread pain and fatigue, among others.
The company announced the approval on Friday evening. Tonmya is a non-opioid, once-daily bedtime analgesic designed for rapid absorption into the bloodstream. It is also the first FDA-approved therapy for the treatment of fibromyalgia in over 15 years, Tonix said.
On Stocktwits, retail sentiment around Tonix trended in the ‘extremely bullish’ territory over the past 24 hours, coupled with ‘extremely high’ message volume. According to Stocktwits data, retail chatter around the stock jumped 72% over the past 24 hours and by 281% over the past seven days.
A Stocktwits user dismissed hopes for a massive rally, adding that ‘this is a marathon not a sprint.’
Another user said they see significant market potential for the drug.
In two late-stage trials, Tonmya significantly reduced fibromyalgia pain compared to placebo at 14 weeks. The drug was generally well-tolerated in late-stage trials, and a greater percentage of study participants taking Tonmya experienced a clinically meaningful improvement in their pain after three months, compared to placebo. Tonmya is expected to be available for adult patients in the U.S. with fibromyalgia beginning in the fourth quarter of this year.
TNXP stock is up by 56% this year and by over 15% over the past 12 months.
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