FAQ: Tonix Pharmaceuticals' TNX-2900 Phase 2 Trial for Prader-Willi Syndrome

What is TNX-2900 and what condition does it treat?

TNX-2900 is a proprietary magnesium-potentiated intranasal oxytocin formulation being developed for Prader-Willi syndrome (PWS), a rare genetic disorder that is a leading cause of life-threatening childhood obesity.

What recent milestone has Tonix achieved with TNX-2900?

The FDA has cleared Tonix’s Investigational New Drug application to begin a Phase 2 clinical trial for TNX-2900 in Prader-Willi syndrome patients.

What special designations has the TNX-2900 program received?

The program has received both Orphan Drug and Rare Pediatric Disease designations from the FDA, which makes Tonix eligible for a transferable Priority Review Voucher upon approval of the drug.

What is Tonix Pharmaceuticals and what other products do they have?

Tonix Pharmaceuticals is a commercial-stage, fully-integrated biotechnology company that recently received FDA approval for Tonmya, a non-opioid analgesic for fibromyalgia, and also markets two treatments for acute migraine in adults.

What other areas is Tonix developing treatments for?

Tonix’s development portfolio focuses on central nervous system disorders, immunology, immuno-oncology and infectious diseases, including treatments for acute stress reaction, organ transplant rejection, autoimmune diseases, mpox/smallpox, and broad-spectrum antiviral agents.

Where can I find more information about Tonix Pharmaceuticals?

Further information about Tonix can be found at www.tonixpharma.com, and the latest news and updates relating to TNXP are available in the company’s newsroom at https://ibn.fm/TNXP.

What is the significance of the Priority Review Voucher mentioned?

The transferable Priority Review Voucher that Tonix becomes eligible for upon approval can expedite FDA review of another drug application and is a valuable asset that can be sold or used for future drug development.

Are any of Tonix’s development products currently approved?

No, Tonix’s product development candidates including TNX-2900 are investigational new drugs or biologics whose efficacy and safety have not been established and have not been approved for any indication, though the company has approved products for other conditions.