CHATHAM, N.J. - Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP), a biopharmaceutical company with a market capitalization of $114 million and impressive revenue growth of 183% in the last twelve months, announced today that the U.S. Food and Drug Administration (FDA) has set a Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025, to complete its review of the New Drug Application (NDA) for TNX-102 SL. This investigational drug is being evaluated for the treatment of fibromyalgia, a chronic pain disorder affecting more than 10 million adults in the United States.
TNX-102 SL is a non-opioid, centrally acting analgesic that has been granted Fast Track designation by the FDA, a status that expedites the review process for drugs that address unmet medical needs. The NDA submission is supported by data from two Phase 3 studies, which indicated that TNX-102 SL could significantly reduce daily pain in fibromyalgia patients.
The CEO of Tonix, Dr. Seth Lederman, expressed optimism about the potential of TNX-102 SL to become the first new drug class for fibromyalgia management in over 15 years, highlighting the drug's favorable tolerability profile demonstrated in clinical trials. According to InvestingPro data, the company has shown strong market momentum with a 15.4% return over the last week and maintains a healthy current ratio of 3.33, indicating solid short-term financial stability. InvestingPro analysis suggests the stock is currently overvalued relative to its Fair Value.
The two 14-week clinical trials, named RELIEF and RESILIENT, met their primary endpoints, showing a significant reduction in daily pain compared to placebo. The most common adverse event reported was temporary tongue or mouth numbness at the administration site.
Fibromyalgia is characterized by chronic widespread pain, non-restorative sleep, and cognitive dysfunction, among other symptoms. Current treatments often leave physicians and patients dissatisfied, pointing to a significant need for new therapeutic options.
TNX-102 SL, a sublingual tablet formulation of cyclobenzaprine hydrochloride, is designed to be taken at bedtime, targeting the non-restorative sleep that is characteristic of fibromyalgia. The formulation aims to deliver the active drug efficiently into the bloodstream, minimizing the risk of daytime somnolence.
The company is also advancing other candidates for central nervous system disorders and has a broader portfolio that includes potential treatments for organ transplant rejection, autoimmune diseases, and vaccines for public health challenges. InvestingPro analysis reveals that while the company holds more cash than debt on its balance sheet, it is currently burning through cash rapidly. Subscribers to InvestingPro have access to 13 additional key insights about Tonix's financial health and market performance.
This article is based on a press release statement from Tonix Pharmaceuticals Holding Corp.
In other recent news, Tonix Pharmaceuticals has made significant strides in advancing its research and development pipeline. The biopharmaceutical company has increased its maximum aggregate offering price from $150 million to $250 million under its existing Sales Agreement with A.G.P./Alliance Global Partners (NYSE:GLP). This move provides Tonix with a broader financial runway to support its ongoing research and development efforts.
The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for TNX-102 SL, a non-opioid treatment for fibromyalgia. This development could signify the introduction of the first new drug for fibromyalgia in over 15 years. The NDA submission is supported by data from two Phase 3 clinical trials.
Tonix has also secured a Department of Defense contract worth up to $34 million for the development of its antiviral drug, TNX-4200, in collaboration with X-Chem, Inc. Additionally, the company has presented promising preclinical data on its mpox vaccine candidate, TNX-801, indicating its potential to prevent mpox and control future epidemics.
Noble Capital analysts have maintained an Outperform rating on Tonix's stock, reflecting confidence in the company's recent developments. The company's commitment to research and development is evident in these recent developments, which are expected to contribute to its long-term growth initiatives.
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