CHATHAM, N.J. - Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP), a ~$99 million market cap biotech company, announced that 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. The stock has shown significant volatility, with InvestingPro data showing a remarkable 170% gain in the past week, though it remains down over 95% year-to-date. The FDA is expected to set a Prescription Drug User Fee Act (PDUFA) target action date and determine if Priority Review will be granted in the upcoming Day 74 Letter.
TNX-102 SL, a sublingual tablet formulation of cyclobenzaprine hydrochloride, received Fast Track designation from the FDA in July 2024, indicating the agency's recognition of the potential treatment's importance for a serious condition with unmet medical needs. This development could mark the introduction of the first new drug for fibromyalgia in over 15 years, addressing the needs of more than 10 million adults in the U.S. affected by this chronic pain disorder.
The NDA submission is supported by data from two Phase 3 clinical trials, RELIEF and RESILIENT, which demonstrated statistically significant reductions in daily pain compared to placebo. TNX-102 SL was generally well tolerated in these studies, with the most common adverse event being temporary tongue or mouth numbness.
Tonix's CEO, Seth Lederman, M.D., expressed the company's commitment to working with the FDA to bring TNX-102 SL to market swiftly. He highlighted the fibromyalgia community's long wait for a new therapeutic option and noted that current treatments often lead to the prescription of addictive opioids.
The company is preparing for potential commercialization in 2025, with a leadership team already supporting marketed migraine treatments Zembrace® SymTouch® and Tosymra®. According to InvestingPro data, Tonix maintains a healthy current ratio of 3.33, indicating strong short-term liquidity, though the company is experiencing rapid cash burn. Revenue growth has been impressive at 183% over the last twelve months, but analysts don't expect profitability this year.
This announcement is based on a press release statement from Tonix Pharmaceuticals. The company's product candidates are investigational and have not yet been approved by the FDA. Tonix's portfolio also includes other central nervous system disorders and public health challenges, such as vaccines for infectious diseases and biologics for pain management.
Investors and the fibromyalgia community will be watching closely as the FDA's review process unfolds, potentially bringing a new class of analgesic to those living with fibromyalgia's chronic widespread pain, non-restorative sleep, and other debilitating symptoms. With the stock currently trading above its InvestingPro Fair Value and showing high volatility, investors should note that 13 additional ProTips are available to help assess the investment opportunity.
In other recent news, Tonix Pharmaceuticals has been making significant strides in the development of its mpox vaccine candidate, TNX-801, in response to public health emergencies. The vaccine has shown promising results in preclinical studies and is less virulent compared to traditional smallpox vaccines. In addition, Tonix has secured a Department of Defense contract worth up to $34 million to expedite the development of its antiviral drug, TNX-4200, in collaboration with X-Chem, Inc.
The company has also submitted a New Drug Application to the U.S. Food and Drug Administration for TNX-102 SL, a non-opioid treatment for fibromyalgia. This is based on two Phase 3 studies showing statistically significant results. Furthermore, Tonix has 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, reflecting confidence in the company's recent developments. These advancements are part of Tonix's ongoing commitment to research and development strategies. The company expects a decision on approval for TNX-102 SL in 2025.
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