Tonix announces PDUFA goal date for FDA decision on MA for TNX-102

Tonix Pharmaceuticals (TNXP) announced that the U.S. Food and Drug Administration, FDA, assigned a Prescription Drug User Fee Act, PDUFA, goal date of August 15, 2025, for a decision on marketing approval, MA, for TNX-102 SL for fibromyalgia. TNX-102 SL is a non-opioid, centrally-acting analgesic. “We look forward to working closely with the FDA throughout the review period in advance of the August 15, 2025, PDUFA goal date,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “We believe that TNX-102 SL has the potential to be the first member of a new class of medicines for the management of fibromyalgia, a debilitating condition affecting over 10 million adults in the U.S. Data from our pivotal Phase 3 trials support that TNX-102 SL can provide fibromyalgia patients with significant reduction in pain with favorable tolerability, helping to address the significant unmet need in this community.”