CHATHAM, N.J. - Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for TNX-102 SL, a non-opioid treatment for fibromyalgia. The application is based on two Phase 3 studies that showed statistically significant results in reducing widespread pain associated with the condition.
TNX-102 SL, if approved, would be the first new fibromyalgia treatment in over 15 years and the first of a new class of drugs for the condition. The drug has received Fast Track designation by the FDA, which is intended to expedite the review process for treatments that address unmet medical needs for serious conditions.
The submission includes data from two 14-week double-blind, randomized, placebo-controlled Phase 3 trials, which demonstrated the drug's efficacy and general tolerability. The most common adverse event reported was tongue or mouth numbness, which was temporary and not severe.
Fibromyalgia affects more than 10 million adults in the U.S., predominantly women, and is characterized by chronic widespread pain, non-restorative sleep, and fatigue. Despite three FDA-approved medications currently available, there remains a significant need for new treatment options.
The TNX-102 SL tablet is a proprietary eutectic formulation designed for sublingual administration at bedtime, targeting the non-restorative sleep that is a hallmark of fibromyalgia. The drug's design aims to reduce the risk of daytime somnolence and is based on cyclobenzaprine HCl's interactions with multiple receptors in the brain.
Tonix Pharmaceuticals focuses on central nervous system disorders and other public health challenges. The company's portfolio includes a range of product candidates for various conditions, including TNX-1300 for cocaine intoxication and TNX-1500 for organ transplant rejection and autoimmune diseases.
The FDA's filing review period for the NDA is typically 60 days to determine if it is complete and ready for a substantive review. Tonix expects a decision on approval in 2025, in accordance with the Prescription Drug User Fee Act (PDUFA).
This news article is based on a press release statement from Tonix Pharmaceuticals Holding Corp.
In other recent news, Tonix Pharmaceuticals has secured a Department of Defense contract up to $34 million for the development of its antiviral drug, TNX-4200, in collaboration with X-Chem, Inc. The company has also been granted patents extending market exclusivity for its migraine treatments, Zembrace® SymTouch® and Tosymra®, until 2036 and 2030, respectively. Analysts from Noble Capital have maintained an Outperform rating on Tonix's stock.
The company is making significant strides in its fibromyalgia treatment, TNX-102 SL, with a New Drug Application expected by October 2024. Tonix has also initiated a share repurchase program, authorizing a buyback of up to $10 million of its outstanding common stock and expanded its maximum aggregate offering price under an existing Sales Agreement with A.G.P./Alliance Global Partners (NYSE:GLP).
Furthermore, Tonix's TNX-801 vaccine aligns with the World Health Organization's criteria for mpox vaccines, demonstrating encouraging preclinical data. These developments are part of Tonix's ongoing commitment to research, development, and financial strategies.
InvestingPro Insights
As Tonix Pharmaceuticals (NASDAQ: TNXP) makes strides with its NDA submission for TNX-102 SL, investors should be aware of some critical financial metrics and trends. According to InvestingPro data, the company's market capitalization stands at a modest $19.74 million, reflecting its current developmental stage.
InvestingPro Tips highlight that Tonix is "quickly burning through cash" and "not profitable over the last twelve months." These factors are particularly relevant given the company's focus on developing new treatments and the significant resources required for clinical trials and regulatory processes. The operating income for the last twelve months as of Q2 2023 was -$95.19 million, underscoring the substantial costs associated with drug development.
Despite the potential of TNX-102 SL, investors should note that the stock price has "fallen significantly over the last year," with a one-year price total return of -99.23% as of the latest data. This decline reflects the challenges and uncertainties inherent in pharmaceutical development, especially for smaller companies like Tonix.
It's worth noting that analysts do not anticipate the company to be profitable this year, which is not uncommon for biotech firms in the development stage. However, with the NDA submission, Tonix may be approaching a critical juncture that could impact its financial outlook.
For a more comprehensive analysis, InvestingPro offers additional tips and insights that could be valuable for investors considering Tonix Pharmaceuticals' potential. There are 11 additional InvestingPro Tips available for TNXP, providing a deeper understanding of the company's financial health and market position.
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