CHATHAM, N.J. - Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP), a biopharmaceutical company, has been granted a new U.S. patent for its migraine medication, Zembrace® SymTouch®. According to the press release statement from the company, the United States Patent and Trademark Office issued U.S. Patent No. 12,097,183 on September 24, 2024. This patent covers the use of a pre-filled autoinjector comprising Zembrace® SymTouch®, which is administered subcutaneously for treating migraines.
The patent is anticipated to extend market exclusivity for Zembrace® SymTouch® until 2036, barring any patent term extensions. Seth Lederman, M.D., CEO of Tonix Pharmaceuticals, expressed optimism about the patent's role in maintaining the company's exclusive rights to market and sell Zembrace® SymTouch® for migraine treatment.
Tonix also recently initiated an educational campaign titled "Does Your Migraine Pill Work Every Time?" The campaign aims to inform patients and healthcare providers about the benefits of non-oral migraine medications, such as nasal sprays and injectables. These alternatives do not depend on the digestive system for absorption, potentially offering quicker relief from migraine symptoms.
The company highlighted the common occurrence of gastroparesis in migraine sufferers, which can impede the effectiveness of oral medications. To further support patient education, Tonix is preparing to launch a new website, www.gpmigraine.com, focusing on the relationship between gastroparesis and migraines.
Tonix's commitment to improving migraine management extends to its broader portfolio, which includes central nervous system disorder treatments and public health solutions. The company is on track to submit a New Drug Application to the FDA for another product candidate, TNX-102 SL, intended for fibromyalgia management, by October 2024.
This news comes as nearly 40 million people in the U.S. suffer from migraines, a condition recognized as the second leading cause of disability worldwide. The new patent represents a significant milestone for Tonix Pharmaceuticals in its efforts to provide alternative treatments for this debilitating condition. The information for this article is based on a press release statement from Tonix Pharmaceuticals Holding Corp.
In other recent news, significant advancements have been made by Tonix Pharmaceuticals in various areas. The company's new drug candidate, TNX-102 SL, designed for fibromyalgia treatment, has shown promising results during the Phase 3 RESILIENT study, with an application for FDA approval expected by 2025. Tonix has also secured a new U.S. patent for its migraine nasal spray, Tosymra®, further strengthening its market presence.
The company's TNX-801 vaccine has demonstrated encouraging preclinical data, effectively protecting animals from a lethal monkeypox challenge. Tonix Pharmaceuticals has also initiated a share repurchase program, authorizing the buyback of up to $10 million of its outstanding common stock and expanding 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).
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 underscore Tonix Pharmaceuticals' active pursuit of research, development, and financial strategies.
InvestingPro Insights
Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) has secured a new patent for its migraine medication, which could be a positive development for the company's intellectual property portfolio and long-term market exclusivity. In light of this news, let's consider some financial metrics and insights that could be relevant for investors monitoring Tonix's performance.
According to InvestingPro data, Tonix's market capitalization stands at a modest $3.01 million, indicating a small-cap company that may have significant room for growth, albeit with the associated risks of smaller market players. The company's Price / Book ratio, based on data from the last twelve months as of Q2 2024, is extremely low at 0.07, which could suggest that the stock is undervalued compared to the company's book value. This aligns with one of the InvestingPro Tips, which notes that the stock is trading at a low Price / Book multiple.
However, the financials also reveal some challenges. The company is operating with a significant debt burden, as highlighted in another InvestingPro Tip. Furthermore, with an operating income margin of -764.06% for the same period, it's clear that the company is facing substantial operational losses. This is consistent with the tip that Tonix is quickly burning through cash, which could be a concern for potential investors.
Despite the company's recent achievements, Tonix's stock price has experienced a significant downturn, as evidenced by a -98.94% year-to-date price total return, and the stock is trading near its 52-week low. Investors should note that the stock price movements are quite volatile, a factor that is underscored by an InvestingPro Tip.
For those interested in a deeper analysis, there are additional InvestingPro Tips available that could provide further context on Tonix's financial health and market performance. These tips can offer valuable insights for making informed investment decisions.
To explore more about Tonix Pharmaceuticals and gain access to all the available InvestingPro Tips, interested readers can visit the dedicated page at InvestingPro.
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