CHATHAM, N.J. - Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP), a biopharmaceutical company, announced today that it is preparing to submit a New Drug Application (NDA) for Tonmya, a potential non-opioid treatment for fibromyalgia, in the latter half of 2024. This follows positive outcomes from two Phase 3 trials, which showed significant results in pain reduction among participants.
The company's announcement coincides with findings from EVERSANA Life Science Services, LLC, indicating a high level of physician interest in Tonmya as a new treatment option for fibromyalgia. Current dissatisfaction with FDA-approved fibromyalgia drugs is notable, with many patients reportedly failing first-line therapy due to efficacy and tolerability issues. Moreover, the analysis revealed that opioids, despite their risks, are more frequently prescribed following a fibromyalgia diagnosis than approved drugs.
Tonix's CEO, Seth Lederman, M.D., expressed optimism about the potential market introduction of Tonmya, highlighting that it has been approximately fifteen years since a new therapeutic option for fibromyalgia patients has been available. The company aims to address the high unmet need for effective and tolerable treatments.
Physicians have shown a median interest level of 4.0 on a 5-point scale for Tonmya, with an intended use for 40% of their fibromyalgia patients upon approval. The medication, a sublingual tablet formulation of cyclobenzaprine hydrochloride, acts centrally and is non-addictive. The RESILIENT study, a second positive Phase 3 clinical trial, met its primary endpoint, significantly reducing daily pain compared to placebo.
Claims data analysis by EVERSANA indicates that approximately 2.7 million adults in the U.S. are currently diagnosed and treated for fibromyalgia, with about 90 percent being female. The Medicare population, which covers roughly half of the diagnosed patients, could benefit from a decrease in out-of-pocket prescription drug costs when the Inflation Reduction Act enacts changes in 2025.
Tonix Pharmaceuticals is focused on developing and commercializing therapeutics for central nervous system disorders and other diseases. The upcoming submission of the NDA for Tonmya is a critical step for the company, with a decision from the FDA expected in 2025. The information in this article is based on a press release statement from Tonix Pharmaceuticals.
InvestingPro Insights
In light of Tonix Pharmaceuticals Holding Corp.'s (NASDAQ: TNXP) announcement regarding the New Drug Application for Tonmya, a non-opioid treatment for fibromyalgia, investors are closely monitoring the company's financial health and stock performance.
According to the latest data from InvestingPro, Tonix's market capitalization stands at a modest $18.15 million, reflecting the size of the company within the biopharmaceutical industry. Despite the promising clinical trial results, the company's financials show challenges, with a negative P/E ratio of -0.07 for the last twelve months as of Q1 2024, indicating that the company is not currently profitable.
InvestingPro Tips suggest a cautious approach for investors. Analysts have revised their earnings upwards for the upcoming period, signaling potential optimism in the company's future performance. Still, it is important to note that Tonix is quickly burning through cash and analysts do not anticipate the company will be profitable this year. Moreover, while the company operates with a moderate level of debt, the valuation implies a poor free cash flow yield.
The stock price has indeed seen a strong return over the last month, with an 18.75% increase, yet it has fallen significantly over the last year by -89.67%. For investors seeking further insights and tips, there are additional InvestingPro Tips available for Tonix Pharmaceuticals, which can be accessed through the InvestingPro platform. Use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, and gain access to a comprehensive list of 12 additional tips that could help in making more informed investment decisions.
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