Tonix Pharmaceuticals Advances TNX-2900 for Prader-Willi Syndrome Into Phase 2 Clinical Trial

The U.S. Food and Drug Administration has cleared Tonix Pharmaceuticals Holding Corp.'s Investigational New Drug application for TNX-2900, allowing the company to advance its proprietary magnesium-potentiated intranasal oxytocin formulation into Phase 2 clinical trials for Prader-Willi syndrome. This development represents a significant step forward in addressing a rare genetic disorder that stands as a leading cause of life-threatening childhood obesity, offering potential new therapeutic options for patients and families affected by this challenging condition.

The regulatory clearance carries additional importance due to the program's designation status. TNX-2900 has received both Orphan Drug and Rare Pediatric Disease designations from the FDA, positioning Tonix Pharmaceuticals to potentially receive a transferable Priority Review Voucher upon approval of the treatment. These designations recognize the significant unmet medical need in Prader-Willi syndrome and provide important incentives for developing treatments for rare conditions that might otherwise receive limited research attention due to small patient populations.

Tonix Pharmaceuticals maintains a diverse development portfolio beyond TNX-2900, with recent regulatory success including FDA approval for Tonmya, a first-in-class, non-opioid analgesic medicine for fibromyalgia treatment. This approval marked the first new prescription medicine for fibromyalgia in more than 15 years, demonstrating the company's capability to advance novel treatments through the regulatory process. Additional information about Tonix's development programs and corporate activities can be found at https://www.tonixpharma.com.

The advancement of TNX-2900 into Phase 2 trials represents an important milestone in the rare disease treatment landscape, particularly for Prader-Willi syndrome patients who currently face limited therapeutic options. The intranasal delivery method of oxytocin, enhanced with magnesium potentiation, offers a novel approach to addressing the complex symptoms of this genetic disorder. Investors and stakeholders can follow further developments through the company's newsroom at https://ibn.fm/TNXP, which provides ongoing updates about Tonix Pharmaceutical's progress across its development pipeline.