CHATHAM, N.J. - Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP), a biopharmaceutical company, has announced its intention to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Tonmya™, a non-opioid analgesic aimed at treating fibromyalgia. The company plans to apply to the second half of 2024 following promising results from two Phase 3 trials.
Fibromyalgia, a chronic pain condition that affects an estimated 10 million U.S. adults, often persists for years and is characterized by symptoms such as widespread pain, fatigue, and sleep disturbances. Current treatments often leave patients and physicians dissatisfied, highlighting a significant need for new therapeutic options.
Tonmya™, or TNX-102 SL, is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride designed for bedtime administration. It has shown statistically significant and clinically meaningful results in reducing daily pain and improving sleep quality, fatigue, and overall symptoms in fibromyalgia patients. These findings come from the RESILIENT study, concluded in December 2023, and the RELIEF trial, completed in December 2020.
The company has engaged Rho, Inc., a global contract research organization, to support the NDA preparation. Seth Lederman, M.D., President and CEO of Tonix Pharmaceuticals, expressed optimism about the recent positive study outcomes and the upcoming submission process.
Tonix also has a broader portfolio of development candidates addressing various central nervous system disorders, including potential treatments for Long COVID and alcohol use disorder, among others.
The company's development of Tonmya™ has been protected by multiple U.S. patents, with market exclusivity expected to last until at least 2034, pending FDA approval. Additional patent applications could extend this exclusivity further.
The information in this article is based on a press release.
InvestingPro Insights
As Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) gears up for a New Drug Application for its promising fibromyalgia treatment, Tonmya™, investors are closely watching the company's financial health and stock performance. Here are some insights based on real-time data from InvestingPro:
The company's market capitalization stands at a modest $21.69 million, reflecting the size and current market valuation of the biopharmaceutical firm. Despite the potential of Tonmya™, the company's financials show a significant burn rate, with an operating income margin of -3103.01% for the last twelve months as of Q3 2023. This may raise concerns about the company's ability to sustain its operations without additional funding or revenue streams.
On the stock performance front, TNXP has demonstrated significant volatility, with a price total return of 12.12% over the last week and 24.92% over the last month. However, the six-month return paints a less rosy picture, with a -61.75% return, signaling the challenges the company faces in maintaining investor confidence over longer periods.
InvestingPro Tips for TNXP reveal a mix of caution and opportunity. The company holds more cash than debt on its balance sheet, which is a positive sign for financial stability. Nonetheless, TNXP is quickly burning through cash, and analysts do not expect the company to be profitable this year. These factors are crucial for investors to consider when evaluating the company's prospects.
For a deeper dive into Tonix Pharmaceuticals and additional InvestingPro Tips, including an assessment of the company's valuation and free cash flow yield, investors can visit InvestingPro. There are 11 more tips available that provide valuable insights into TNXP's financial health and stock performance. To access these insights and more, use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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