Business
Tonix Pharmaceuticals Reports First Quarter 2024 Financial Results and Operational Highlights
On track to submit NDA in the second half of 2024 for Tonmya™ for fibromyalgia; pre-NDA meeting with FDA scheduled for second quarter 2024 Commercial planning
About this update from Tonix Pharmaceuticals Holding Corp.
[{"type":"text","content":"On track to submit NDA in the second half of 2024 for Tonmya™ for fibromyalgia; pre-NDA meeting with FDA scheduled for second quarter 2024 Commercial planning continues for U.S. launch of Tonmya, a potential new first-line, centrally-acting, non-opioid analgesic for the management of fibromyalgia CHATHAM, N.J., May 13, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced financial results for the first quarter ended March 31, 2024, and provided an overview of recent operational highlights. “Our near-term priority continues to be the submission of our New Drug Application (NDA) for Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia, while continuing to build out our commercial strategy for the anticipated product launch in the event of FDA approval, which we currently estimate to occur in the second half of 2025,” said Seth Lederman, M.D., Chief Executive Officer of Tonix. Dr. Lederman added, “The well-known treatment-limiting side effects of the three currently approved drugs have led to widespread patient dissatisfaction, creating what we believe is a significant opportunity for a new therapeutic. Tonmya has a differentiated mechanism of action and is generally free of common side effects associated with the currently approved products, including weight gain, fatigue, insomnia, increased blood pressure, gastrointestinal issues or sexual dysfunction. As such, we believe Tonmya, if approved, could become the treatment of choice for the approximately 10 million people in the U.S. suffering the debilitating effects of fibromyalgia.” The Company is also advancing other key pipeline programs including those for immunology, obesity, eating disorders, infectious and rare diseases, many through a capital efficient strategy involving partnerships, grants and in-kind contributions. Recent Highlights – Key Product Candidates* Central Nervous System (CNS) Pipeline Tonmya (also known as TNX-102 SL; cyclobenzaprine HCl sublingual tablets): a centrally-acting, non-opioid, small molecule analgesic taken once-daily at bedtime for the management of fibromyalgia (FM). In January 2024, Tonix presented additional safety and tolerability data from ...