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Tonix Pharmaceuticals | 8-K: Tonix Pharmaceuticals Announces FDA IND Clearance for DoD Funded Trial of TNX-102 SL for the Reduction of Acute Stress Reaction and Prevention of PTSD

SEC announcement ·  Feb 12 20:09
Summary by Futu AI
On February 12, 2024, Tonix Pharmaceuticals Holding Corp. announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for the Phase 2 OASIS trial. The trial, 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, will evaluate the efficacy of TNX-102 SL in reducing the severity of acute stress reaction (ASR) and the frequency of acute stress disorder (ASD) and posttraumatic stress disorder (PTSD) in trauma survivors. The trial will enroll approximately 180 patients and aims to address the unmet need for treating ASR immediately after traumatic events. Tonix Pharmaceuticals also updated its investor presentation and intends to place it on its website. The company is focused on central nervous system disorders and is preparing to submit a New Drug Application (NDA) for Tonmya, a product candidate for the management of fibromyalgia, in the second half of 2024.
On February 12, 2024, Tonix Pharmaceuticals Holding Corp. announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for the Phase 2 OASIS trial. The trial, 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, will evaluate the efficacy of TNX-102 SL in reducing the severity of acute stress reaction (ASR) and the frequency of acute stress disorder (ASD) and posttraumatic stress disorder (PTSD) in trauma survivors. The trial will enroll approximately 180 patients and aims to address the unmet need for treating ASR immediately after traumatic events. Tonix Pharmaceuticals also updated its investor presentation and intends to place it on its website. The company is focused on central nervous system disorders and is preparing to submit a New Drug Application (NDA) for Tonmya, a product candidate for the management of fibromyalgia, in the second half of 2024.
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