CHATHAM, N.J. - Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP), a biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for a Phase 2 trial to evaluate the efficacy of TNX-102 SL in treating acute stress reactions (ASR) and reducing the onset of acute stress disorder (ASD) and posttraumatic stress disorder (PTSD) following traumatic events. This trial is notably sponsored by The University of North Carolina (UNC) Institute for Trauma Recovery and supported by a $3 million grant from the U.S. Department of Defense (DoD).
The trial, named Optimizing Acute Stress Reaction Interventions with TNX-102 SL (OASIS), aims to assess the safety and effectiveness of TNX-102 SL in mitigating adverse posttraumatic neuropsychiatric sequelae among trauma survivors arriving at emergency departments (ED) after motor vehicle collisions. The study will recruit approximately 180 patients from ED sites across the United States, who will be randomly assigned to receive a two-week course of either TNX-102 SL or a placebo.
Tonix's CEO, Seth Lederman, M.D., highlighted the lack of immediately available treatments for individuals suffering from traumatic events and the potential of TNX-102 SL to improve sleep quality and reduce ASR symptoms. The drug's sleep-enhancing properties were previously observed in PTSD trials, suggesting it could be beneficial in the early treatment phase following trauma.
The OASIS trial builds on the extensive research infrastructure of the $40 million AURORA initiative, a significant national research effort to advance the understanding and treatment of individuals who have experienced traumatic events. The initiative is backed by the National Institutes of Health (NIH), One Mind, private foundations, and partnerships with tech companies such as Mindstrong Health and Verily Life Sciences.
Tonix also focuses on developing treatments for various central nervous system disorders and plans to meet with the FDA in the first half of 2024 to discuss a New Drug Application for TNX-102 SL for fibromyalgia management, with submission anticipated in the second half of the year.
This information is based on a press release statement from Tonix Pharmaceuticals Holding Corp.
InvestingPro Insights
As Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) spearheads innovative clinical trials to combat acute stress reactions and related disorders, the company's financial health and stock performance are critical factors for investors to consider. According to InvestingPro data, Tonix holds a market capitalization of approximately $19.34 million USD, indicating its size within the biopharmaceutical sector. Despite the company's ambitious clinical endeavors, Tonix has reported a negative operating income margin of over -3100% for the last twelve months as of Q1 2023, highlighting the significant costs associated with its research and development activities.
Investors should note that Tonix's stock price has experienced substantial volatility, with a one-year price total return as of Y2024.D43 at -94.97%, reflecting the inherent risks and speculative nature often found in the biotech industry. This is echoed by one of the InvestingPro Tips, which points out that the stock price movements are quite volatile, a factor that potential investors must weigh against the company's future prospects and current cash position, which holds more cash than debt on the balance sheet.
For those interested in a deeper analysis of Tonix's financials and stock performance, InvestingPro offers additional insights, including 10 more InvestingPro Tips for TNXP. These tips provide a comprehensive look at the company's financial health and market expectations, which could be pivotal in making informed investment decisions. To explore these insights further, visit https://www.investing.com/pro/TNXP and consider using the coupon code PRONEWS24 to receive an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.