CHATHAM, N.J. - Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP), a biopharmaceutical company, has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for Tonmya™, a non-opioid treatment for fibromyalgia. The decision, announced today, marks a significant step towards addressing the needs of over 10 million U.S. adults suffering from this chronic pain condition.
Tonmya™, also known as TNX-102 SL, is a sublingual tablet formulation of cyclobenzaprine hydrochloride developed for management of fibromyalgia, a disorder characterized by widespread musculoskeletal pain accompanied by fatigue, sleep, memory, and mood issues.
The FDA's Fast Track process aims to expedite the development and review of drugs intended to treat serious conditions and fill an unmet medical need, potentially bringing new treatments to patients more swiftly.
The company has aligned with the FDA on the content of its New Drug Application (NDA) submission, which it reaffirms is on track for the second half of 2024. If approved, Tonmya would be the first new pharmacotherapy for fibromyalgia in over 15 years. Tonix's CEO, Seth Lederman, M.D., expressed that the designation supports their goal of introducing Tonmya as a well-tolerated, non-opioid analgesic to the market, potentially in 2025.
Tonmya has demonstrated positive results in two pivotal Phase 3 trials, RESILIENT and RELIEF, significantly reducing daily pain compared to placebo and showing improvement in key secondary endpoints related to sleep quality, fatigue, and overall fibromyalgia symptoms and function.
The most common treatment-emergent adverse event in these studies was temporary tongue or mouth numbness, which was never severe and rarely led to discontinuation of the study. Tonix's ongoing discussions with the FDA have included alignment on nonclinical, clinical pharmacology, clinical, and CMC aspects of the upcoming NDA submission.
Tonix is also developing other central nervous system (CNS) disorder treatments, including TNX-1300 for cocaine intoxication, which has Breakthrough Therapy designation, and immunology biologics for organ transplant rejection, autoimmunity, and cancer.
The information in this article is based on a press release statement from Tonix Pharmaceuticals Holding Corp.
In other recent news, Tonix Pharmaceuticals has secured a significant contract with the Defense Threat Reduction Agency (DTRA), a part of the U.S. Department of Defense. The $34 million agreement, spread over five years, is focused on the development of broad-spectrum antiviral agents, specifically TNX-4200, with the intention of enhancing the medical readiness of U.S. military personnel against potential biological threats.
This funding will support the establishment of TNX-4200's physicochemical properties, pharmacokinetics, and safety profiles, and will finance a first-in-human Phase 1 clinical study.
Moreover, Tonix Pharmaceuticals has announced a public offering of approximately 7.1 million shares, projected to raise $4 million before fees and expenses. The raised funds will be allocated towards working capital and general corporate uses, including advancing Tonmya, a fibromyalgia treatment candidate. Dawson James Securities, Inc. is serving as the sole placement agent for this offering.
In addition, the company is preparing to submit a New Drug Application to the FDA for Tonmya in the latter half of 2024. Tonmya represents a new therapeutic class for fibromyalgia management and has shown statistically significant improvements in fibromyalgia pain and sleep quality in recent clinical trials.
Still, Noble Capital recently revised its price target for Tonix's shares, lowering it to $1.50 from the previous $10.00, while maintaining an Outperform rating on the stock. These are the recent developments at Tonix Pharmaceuticals.
InvestingPro Insights
In light of Tonix Pharmaceuticals Holding Corp.'s (NASDAQ: TNXP) recent FDA Fast Track designation for Tonmya™, investors may be closely monitoring the company's financial health and market performance. According to InvestingPro data, TNXP currently has a market capitalization of approximately $9.2 million USD. The company's Price / Book ratio, as of the last twelve months leading up to Q1 2024, stands at a low 0.09, which may suggest that the company's stock is potentially undervalued relative to its book value.
However, the financial metrics also reveal significant challenges. TNXP has an operating income margin of -1032.48% for the same period, indicating substantial operating losses in relation to its revenue. The company's Price Total Return over the last year has been -99.04%, reflecting a steep decline in the stock's market price.
InvestingPro Tips provide further insights that can help investors better understand the stock's current position. Analysts have revised their earnings upwards for the upcoming period, which could signal expectations of improved financial performance ahead. Another key point is that TNXP's Relative Strength Index (RSI) suggests the stock is in oversold territory, which might attract investors looking for potential rebounds in the stock price.
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