CHATHAM, N.J. - Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP), a biopharmaceutical company, announced positive results from its Phase 3 RESILIENT study of TNX-102 SL, a sublingual formulation of cyclobenzaprine hydrochloride, for the treatment of fibromyalgia. The study met its primary endpoint of reducing daily pain significantly compared to a placebo, as well as showing improvement in all six key secondary endpoints, which include sleep quality, fatigue, and overall fibromyalgia symptoms and function.
The data were presented at the Military Health System Research Symposium in Kissimmee, Fla., earlier this week. According to the company, the post hoc analysis of the study demonstrated strong correlations between improvements in pain and sleep quality, highlighting the potential of TNX-102 SL to provide broad-spectrum symptom relief for fibromyalgia patients.
Fibromyalgia, a chronic pain disorder affecting more than 10 million adults in the U.S., is characterized by widespread pain, non-restorative sleep, and fatigue, among other symptoms. Current treatments often fall short of patient needs, and TNX-102 SL is being positioned as the first new treatment option for fibromyalgia in over a decade.
The investigational drug is also being explored for its potential in treating other chronic overlapping pain conditions and is part of a study for acute stress disorder in collaboration with the U.S. Department of Defense.
Tonix emphasized that TNX-102 SL was well tolerated in the study, with an adverse event profile consistent with prior studies and no new safety signals observed. The most common treatment-emergent adverse event reported was tongue or mouth numbness, which was temporary and rarely led to study discontinuation.
The company has been granted Fast Track designation by the FDA for TNX-102 SL and is on track to submit a new drug application in the second half of 2024, with an FDA decision expected in 2025.
This announcement is based on a press release statement from Tonix Pharmaceuticals Holding Corp. and represents the company's current trajectory in the development of TNX-102 SL for the management of fibromyalgia.
In other recent news, Tonix Pharmaceuticals, in partnership with Bilthoven Biologicals, has advanced the development of its mpox vaccine candidate, TNX-801. This comes in response to the World Health Organization's declaration of the mpox outbreak in African countries as a public health emergency. The vaccine, currently in pre-clinical development, is based on horsepox technology and has shown promising results in preclinical studies.
Simultaneously, Tonix has initiated a Phase 2 trial for TNX-1300, a potential treatment for acute cocaine intoxication. The company has also reported positive results from its Phase 3 RESILIENT study for TNX-102 SL, a drug aimed at managing fibromyalgia.
Financially, Tonix has announced a public offering of approximately 7.1 million shares, expected to raise $4 million before deducting fees and expenses. In analyst notes, Noble Capital has maintained an Outperform rating on Tonix's stock, albeit with a lowered target to $1.50 from the previous $10.00. These are the recent developments at Tonix Pharmaceuticals.
InvestingPro Insights
In the wake of Tonix Pharmaceuticals Holding Corp.'s promising announcement regarding their Phase 3 study, investors and industry observers are closely monitoring the company's financial health and market performance. According to InvestingPro, Tonix Pharmaceuticals has experienced significant price volatility, which is an important consideration for potential investors. The stock has shown high price volatility (InvestingPro Tip), which may be attributed to the speculative nature of biopharmaceutical companies whose valuations are often closely tied to the success or failure of their developmental drugs.
Furthermore, the company's stock price has faced a downward trend over the last month (InvestingPro Tip), which could be reflective of broader market sentiments or specific concerns about the company's burn rate and long-term profitability. Analysts are not anticipating the company to be profitable this year (InvestingPro Tip), a critical point for investors to consider when evaluating the stock's future potential.
From a financial standpoint, Tonix Pharmaceuticals' market capitalization stands at a modest $7.99 million, and the company's Price/Book ratio as of the last twelve months leading up to Q2 2024 is 0.19, indicating that the stock may be undervalued relative to the company's book value (InvestingPro Data). Despite the challenges, the company's recent clinical success could potentially shift its financial trajectory if the new drug application for TNX-102 SL is favorably reviewed by the FDA.
For those interested in a deeper dive into Tonix Pharmaceuticals' financials and market performance, InvestingPro offers additional insights and tips, which can be accessed at https://www.investing.com/pro/TNXP. With a total of 13 additional InvestingPro Tips available, investors can gain a more comprehensive understanding of the company's investment profile.
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