CHATHAM, NJ - Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) is preparing to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for its fibromyalgia treatment, Tonmya™, in the second half of 2024. Pending FDA approval, expected in the latter half of 2025, Tonmya could become a new option for the estimated 2.7 million Americans diagnosed with fibromyalgia, a market that has not seen a new FDA-approved drug since 2009.
The potential introduction of Tonmya, also known as TNX-102 SL, is significant as it represents a new therapeutic class for fibromyalgia management. Unlike the three currently approved drugs, which target both serotonin and norepinephrine or are more specific for norepinephrine, Tonmya focuses on improving sleep quality—a key issue for fibromyalgia patients—without affecting serotonin levels.
In recent clinical trials, Tonmya demonstrated a statistically significant improvement in fibromyalgia pain, with a p-value of 0.00005. Additionally, improvements were noted in sleep quality, depression, fatigue, and overall symptoms and function. Tonmya was generally well tolerated, with the most common adverse events being transient sensations in the mouth.
The global fibromyalgia market, valued at over $3 billion in 2023, is anticipated to grow annually by 3.8% through 2030. Tonix is set to compete in this space, which has long been dominated by generic versions of previously blockbuster drugs.
The company has completed its final pre-NDA meeting with the FDA and has progressed through manufacturing and multidisciplinary-focused pre-NDA meetings, indicating readiness for the upcoming submission.
Tonix's announcement comes as another U.S. company is also advancing a new drug candidate toward FDA approval, suggesting the potential for increased competition in the fibromyalgia treatment market.
Tonmya has been conditionally accepted as a trade name by the FDA, but it remains an investigational new drug and has not yet been approved for any indication.
This press release statement serves as the basis for the current update on Tonix Pharmaceuticals' progress toward the commercialization of Tonmya.
In other recent news, Tonix Pharmaceuticals has announced a public offering of approximately 7.1 million shares, expected to raise $4 million before deducting fees and expenses. The funds will be allocated towards working capital and general corporate uses, including advancing Tonmya™. Dawson James Securities, Inc. is serving as the sole placement agent for the offering.
Simultaneously, Tonix Pharmaceuticals has secured a $34 million contract with the Defense Threat Reduction Agency (DTRA) for the development of broad-spectrum antiviral agents. The funding will support the advancement of the company's TNX-4200 program, aimed at enhancing the medical readiness of U.S. military personnel against biological threats.
In addition, Noble Capital recently revised its price target for Tonix's shares, maintaining an Outperform rating on the stock but lowering the target to $1.50 from the previous $10.00.
These recent developments reflect significant progress for Tonix Pharmaceuticals in both its research and financial endeavors.
InvestingPro Insights
As Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) advances its drug candidate Tonmya™ towards an NDA submission, investors and stakeholders are closely monitoring the company's financial health and market performance. According to InvestingPro data, Tonix's market capitalization stands at a modest $10.66 million, reflecting the company's status as a smaller player in the pharmaceutical industry. The company's Price / Book ratio, as of the last twelve months ending in Q1 2024, is notably low at 0.1, which can be indicative of the market undervaluing the company's assets relative to its share price.
However, an InvestingPro Tip points out that Tonix is trading at a low Price / Book multiple, which could be appealing to value investors looking for potentially undervalued stocks. Another critical InvestingPro Tip suggests that the Relative Strength Index (RSI) indicates the stock is in oversold territory, hinting at a potential rebound if market sentiment shifts following positive developments, such as progress with the FDA.
For readers interested in deeper analysis, InvestingPro offers additional insights, with a total of 16 InvestingPro Tips available for TNXP at https://www.investing.com/pro/TNXP. These tips can provide a more comprehensive understanding of the stock's technical and fundamental aspects. To access these valuable insights, use the coupon code PRONEWS24 to receive up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription.
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