Tonix Pharmaceuticals making progress on NDA for TNX-102 SL drug and received funding
From GlobeNewswire: 2024-08-19 06:00:00
Tonix Pharmaceuticals Holding Corp is on track to submit a New Drug Application (NDA) in the second half of 2024 for TNX-102 SL, a potential new first-line, non-opioid analgesic for fibromyalgia. The FDA has granted Fast Track designation for this drug. Additionally, the company has been granted a $34 million contract by the U.S. Department of Defense to develop a broad-spectrum antiviral drug. The World Health Organization has declared the spread of mpox in multiple African countries a public health emergency of international concern, but Tonix is working on an mpox vaccine called TNX-801.
Tonix Pharmaceuticals has recently announced financial results for the second quarter of 2024. The company has made significant progress in advancing the NDA and market access strategy for TNX-102 SL. The drug has been granted Fast Track designation by the FDA and is in alignment with the agency regarding the NDA package content. TNX-102 SL aims to be the first new drug to treat fibromyalgia in over 15 years. Additionally, Tonix is working on other key pipeline candidates, including TNX-4200, a broad-spectrum antiviral program, for which the company received funding from the U.S. Department of Defense.
TNX-102 SL is a centrally-acting, non-opioid analgesic for fibromyalgia that is taken once-daily at bedtime. The drug has shown promise in treating symptoms such as anxiety, depression, and memory problems in patients with fibromyalgia. TNX-102 SL has been granted Fast Track designation by the FDA for the management of fibromyalgia. Tonix also plans to initiate a Phase 2 trial to evaluate the drug for the treatment of Acute Stress Disorder.
Tonix Pharmaceuticals is also working on other pipeline candidates, including TNX-1300, a biologic for life-threatening cocaine intoxication, and TNX-1900, a small peptide in development for adolescent obesity, binge eating disorder, and other conditions. TNX-1300 has been granted Breakthrough Therapy designation by the FDA, while TNX-1900 is being studied in ongoing investigator-initiated Phase 2 trials. Tonix continues to advance its pipeline through a capital efficient strategy, focusing on developing innovative therapies for unmet medical needs.
Read more at GlobeNewswire:: Tonix Pharmaceuticals Reports Second Quarter 2024 Financial