CHATHAM, N.J. - Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) has reported significant advancements in the development of its new drug candidate TNX-102 SL, a sublingual formulation of cyclobenzaprine hydrochloride, for the treatment of fibromyalgia. The company presented data at the 11th Global Conference on Pharmaceutics and Novel Drug Delivery Systems, which concluded last Wednesday in Rome, Italy.
The presentations focused on the proprietary formulation technology and pharmacokinetic properties of TNX-102 SL. The drug's eutectic composition, which is expected to provide market exclusivity until at least 2034 across various jurisdictions including the U.S., E.U., Japan, and China, is based on a stable product that dissolves rapidly for efficient transmucosal absorption into the bloodstream.
Tonix's CEO, Seth Lederman, highlighted the issuance of patents in multiple regions and the maintenance of the European patent after opposition from Hexal AG, a Sandoz (SIX:SDZ) subsidiary. The U.S. Food and Drug Administration (FDA) has granted TNX-102 SL Fast Track designation, with a New Drug Application (NDA) submission on track for October 2024 and a Prescription Drug User Fee Act (PDUFA) date in 2025 expected for FDA approval decision.
The Phase 3 RESILIENT study of TNX-102 SL demonstrated statistically significant improvement in the primary endpoint of fibromyalgia nociplastic pain and in all six key secondary endpoints, including sleep quality. The drug was well tolerated, with an adverse event profile comparable to prior studies and no new safety signals observed.
Bruce Daugherty, Ph.D., Executive Vice President of Research at Tonix, outlined the clinical pharmacology of TNX-102 SL, emphasizing its potential to provide broad-spectrum symptom relief in fibromyalgia as a once-daily treatment at bedtime.
In addition to the clinical benefits, Tonix also presented in vitro discriminatory tests that support an efficient clinical development process and provide a strategy to evaluate manufacturing processes and product uniformity.
This news, based on a press release statement, indicates that TNX-102 SL could potentially be the first new treatment option for fibromyalgia patients in 15 years, addressing a significant unmet need in the condition's management.
In other recent news, Tonix Pharmaceuticals has secured a new U.S. patent for its migraine nasal spray, Tosymra®. This development fortifies the market presence of Tosymra®, which is recognized for its unique administration method. Alongside this, Tonix is making strides in its research, with its TNX-801 vaccine showing promising preclinical data in protecting animals from a lethal monkeypox challenge, and positive results from its Phase 3 RESILIENT study of TNX-102 SL for the treatment of fibromyalgia.
The company has also initiated a share repurchase program, authorizing the buyback of up to $10 million of its outstanding common stock. Furthermore, Tonix has expanded its maximum aggregate offering price from $50 million to $150 million under an existing Sales Agreement with A.G.P./Alliance Global Partners (NYSE:GLP). This move triples the potential financial influx from the equity market, providing a more robust financial framework for the company's ongoing operations and development activities.
In analyst notes, Noble Capital has maintained an Outperform rating on Tonix's stock, albeit with a lowered target to $1.50 from the previous $10.00. These recent developments highlight Tonix Pharmaceuticals' active pursuit of research, development, and financial strategies.
InvestingPro Insights
As Tonix Pharmaceuticals (NASDAQ:TNXP) progresses with its promising drug candidate TNX-102 SL for fibromyalgia, it's crucial for investors to stay informed about the company's financial health and market performance. According to InvestingPro data, Tonix has a market capitalization of a modest $3.25 million, reflecting the size and current valuation of the company in the market. The Price / Book ratio as of the last twelve months stands at 0.08, indicating that the stock may be trading at a low multiple of its book value.
The company's financial metrics reveal challenges, with a significant operating income margin deficit of -764.06% over the last twelve months, which underscores the costs outweighing the revenue generated within the same period. This financial situation is consistent with one of the InvestingPro Tips, which indicates that Tonix is quickly burning through cash, a critical factor for investors to consider given the company's ongoing research and development expenses.
Moreover, the stock price has experienced a precipitous decline, with a 1-year price total return of -99.43%, as noted in the InvestingPro data. This aligns with another InvestingPro Tip that suggests the stock price has been quite volatile, which could be a point of concern or opportunity, depending on an investor's strategy and risk tolerance. Investors interested in a deeper analysis can find an additional 14 InvestingPro Tips for TNXP at https://www.investing.com/pro/TNXP, providing a comprehensive view of the company's investment potential.
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