CHATHAM, N.J. - Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP), a biopharmaceutical company, announced plans to initiate a Phase 2 trial in the third quarter of 2024, aiming to assess the efficacy of TNX-102 SL for reducing the severity of acute stress reaction (ASR) and the frequency of acute stress disorder (ASD) and posttraumatic stress disorder (PTSD). The trial will focus on patients who have experienced traumatic events, a patient group currently lacking FDA-approved medications at the point-of-care for such conditions.
The decision to proceed with the trial follows the presentation of clinical data at the 2024 Military Health System Research Symposium, held in Kissimmee, Fla. The data showed that TNX-102 SL, when administered within 24 hours of a trauma event, could potentially reduce ASR/ASD symptoms, which are similar to those of PTSD. The medication has been well-tolerated in previous studies, with no recognized liability for tolerance or abuse.
The upcoming trial, named the Optimizing Acute Stress Reaction Interventions (OASIS), is funded by the U.S. Department of Defense and will be conducted under an investigator-initiated investigational new drug (IND) application by the University of North Carolina. It will test TNX-102 SL's potential to improve trauma-related sleep disturbances and facilitate recovery from ASR, as well as prevent PTSD. Approximately 180 trauma survivors from emergency departments across the U.S. will be enrolled and randomized to receive a two-week course of TNX-102 SL or placebo.
Tonix's CEO, Seth Lederman, M.D., emphasized the importance of early intervention and the potential benefits of TNX-102 SL on sleep quality and subsequent recovery from trauma. The OASIS study builds upon the AURORA initiative, a national research effort to enhance the understanding and treatment of trauma.
The press release also highlighted a third poster presentation at the symposium, which introduced an automated high-throughput scratch assay that could accelerate the discovery of new wound-healing therapies.
Tonix Pharmaceuticals focuses on developing therapeutics for central nervous system disorders and other areas, including immunology and infectious disease. The company has a portfolio of development candidates and recently received a contract from the U.S. Department of Defense to develop antiviral agents.
This article is based on a press release statement from Tonix Pharmaceuticals Holding Corp.
In other recent news, Tonix Pharmaceuticals has reported positive results from its Phase 3 RESILIENT study of TNX-102 SL, a sublingual formulation of cyclobenzaprine hydrochloride, for the treatment of fibromyalgia. The study met its primary endpoint of reducing daily pain significantly compared to a placebo, as well as showing improvement in all six key secondary endpoints. Tonix has also advanced the development of its mpox vaccine candidate, TNX-801, in partnership with Bilthoven Biologicals, in response to the World Health Organization's declaration of the mpox outbreak in African countries as a public health emergency. Furthermore, Tonix has initiated a Phase 2 trial for TNX-1300, a potential treatment for acute cocaine intoxication.
In terms of financial news, Tonix has announced a public offering of approximately 7.1 million shares, expected to raise $4 million before deducting fees and expenses. Analyst firm 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' ongoing efforts in various therapeutic areas and its financial strategies. The company's initiatives underscore its commitment to addressing significant health challenges through innovative solutions.
InvestingPro Insights
As Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) gears up for its Phase 2 trial of TNX-102 SL, investors are closely monitoring the company's financial health and market performance. According to InvestingPro data, Tonix has a market capitalization of $6.61 million, reflecting the market's current valuation of the company. Additionally, the company's revenue over the last twelve months as of Q2 2024 stands at $12.46 million, with a gross profit of $2.69 million, indicating a gross profit margin of 21.59%. These figures are crucial for stakeholders to understand the company's financial standing as it invests in clinical trials.
InvestingPro Tips highlight several key aspects that investors should consider. The Relative Strength Index (RSI) suggests that TNXP stock is currently in oversold territory, which could attract traders looking for potentially undervalued opportunities. Moreover, analysts do not expect the company to be profitable this year, which is a significant consideration for long-term investors. It's also noted that the stock price has experienced high volatility, which could be attributed to the speculative nature of the biopharmaceutical industry and the outcomes of ongoing clinical trials.
For those interested in a deeper analysis, InvestingPro offers additional insights and tips on TNXP, providing a more comprehensive understanding of the company's financial health and market performance. As of now, there are 16 additional InvestingPro Tips available for Tonix Pharmaceuticals, which can be accessed for further investment evaluation.
With the company's next earnings date set for November 4, 2024, stakeholders will be looking forward to updates on the OASIS study and other developments that might influence the company's financial trajectory and stock performance.
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