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Tonix Pharmaceuticals Presents Tonmya Study Data at IASP World Congress on Pain

Tonix Pharmaceuticals presented data from an analysis of the Phase 3 RELIEF and RESILIENT studies of Tonmya for the treatment of fibromyalgia in adults demonstrating outcomes as measured by the Fibromyalgia Impact Questionnaire-Revised, or FIQR, at the International Association for the Study of Pain, or IASP, 2026 World Congress on Pain, held October 26-30 in Bangkok, Thailand. RELIEF and RESILIENT were randomized, double-blind, placebo-controlled Phase 3 trials that assessed the efficacy and safety of Tonmya versus placebo over 14 weeks in adults with fibromyalgia who were diagnosed with the condition diagnosed according to the 2016 American College of Rheumatology diagnostic criteria. In both trials, participants were randomized 1:1 to receive either TONMYA or matching placebo for 14 weeks. RELIEF and RESILIENT evaluated the same primary efficacy and key secondary efficacy endpoints. The primary efficacy endpoint was the change from baseline in the weekly average of daily self-reported numeric rating scale, or NRS, pain scores at Week 14. There were multiple key secondary efficacy endpoints, including change from baseline in the FIQR Symptoms domain score and change from baseline in the FIQR Function domain score. The FIQR assesses overall fibromyalgia burden and severity over the prior seven days, including physical functioning and symptoms. FIQR assessments were conducted at Weeks 2, 6, 10, and 14, with Week 14 as the pre-specified timepoint of interest. In the RELIEF and RESILIENT studies, Tonmya provided statistically and clinically significant improvements over placebo in the change from baseline in the weekly average of daily numeric rating scale pain scores versus placebo at Week 14. A greater reduction from baseline in both the FIQR Symptoms and FIQR Function total scores was seen in participants who received Tonmya as compared to those who received placebo at Weeks 2, 6, 10, and 14 in both studies. Week 14 was statistically significant for both domains in RESILIENT and nominally significan in RELIEF. Tonmya was generally well tolerated, with an adverse event profile consistent with previous studies; no new safety signals were observed. The most common treatment-emergent adverse events were local oral administration site reactions.

Tonix Pharmaceuticals Secures Medicare Agreement Covering 21 Million Lives

Tonix Pharmaceuticals announced a second major managed Medicare agreement for TONMYA for the treatment of fibromyalgia in adults that is effective immediately, adding approximately 21M Medicare lives. Medicare coverage now totals 32 million Medicare lives in the U.S. "The second major managed Medicare agreement expands patient access to TONMYA, the first fibromyalgia treatment approved in over 15 years," said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. "We believe the commercial and managed Medicare coverage agreements reflect TONMYA's compelling value to patients and payers as a first-in-class, non-opioid analgesic designed for daily bedtime administration and long-term use in adults with fibromyalgia."

Tonix Pharmaceuticals Appoints Thomas Englese as Chief Commercial Officer

Tonix Pharmaceuticals announced the promotion of Thomas Englese to chief commercial officer, effective immediately. Englese has served as Tonix's executive VP, commercial operations, since September 2024.