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Tonix Pharmaceuticals announced FDA acceptance of its NDA for TNX-102 SL, a non-opioid analgesic for fibromyalgia, with potential to be the first new drug for the condition in over 15 years. The NDA is supported by two Phase 3 studies showing significant pain reduction and good tolerability.

Tonix Pharmaceuticals appoints Bradley Raudabaugh as VP of Marketing and Errol Gould as VP of Medical Affairs to support the launch of TNX-102 SL for fibromyalgia. The NDA for TNX-102 SL was submitted to the FDA in October 2024, with an expected decision in 2025, potentially marking the first new drug for fibromyalgia in over 15 years.

Tonix Pharmaceuticals' COO Jessica Morris to present at NobleCon20 on Dec 3, highlighting TNX-102 SL for fibromyalgia (FDA Fast Track), TNX-1300 for cocaine intoxication, TNX-1500 for organ transplant rejection, and a $34 million DoD contract for TNX-4200 antiviral agents.

Tonix Pharmaceuticals Holding Corp. announced that CEO Seth Lederman will present at BIO-Europe on Nov 4, 2024, in Stockholm. Tonix is a biopharmaceutical company with a focus on CNS disorders, including TNX-102 SL for fibromyalgia and TNX-1300 for cocaine intoxication. The company also develops biologics for organ transplant rejection, autoimmunity, and cancer, and has a vaccine candidate for mpox. Tonix operates an infectious disease research facility and markets Zembrace SymTouch and Tosymra for migraine treatment.

Tonix Pharmaceuticals' COO Jessica Morris to present at the 2024 ThinkEquity Conference on Oct 30, discussing TNX-102 SL for fibromyalgia and a $34M DoD contract for TNX-4200 development. Tonix Medicines markets Zembrace SymTouch and Tosymra for acute migraine.

Tonix Pharmaceuticals submitted an NDA to the FDA for TNX-102 SL, a non-opioid analgesic for fibromyalgia, based on two successful Phase 3 studies showing significant pain reduction. The drug targets non-restorative sleep and has Fast Track designation, potentially expediting review. If approved, it would be the first new fibromyalgia drug in over 15 years.

Tonix Pharmaceuticals submits NDA for TNX-102 SL, a non-opioid, centrally-acting analgesic for fibromyalgia, after two Phase 3 studies showed significant pain reduction. If approved, TNX-102 SL would be the first new drug for fibromyalgia in over 15 years.

Tonix Pharmaceuticals CEO, Dr. Seth Lederman, participated in the 'RECOVER Treating Long COVID (TLC) - Navigating the Pathway Forward' workshop, discussing clinical trial endpoints for Long COVID therapeutics. Lederman highlighted the potential of Patient Global Impression of Change (PGIC) as a primary endpoint for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME)-type Long COVID, drawing parallels to Progression-Free Survival (PFS) in cancer drug development.

Tonix Pharmaceuticals CEO Seth Lederman participated in the 'Endpoints' panel at the RECOVER Treating Long COVID workshop, discussing clinical trial endpoints for potential Long COVID therapeutics. Lederman recommended validating Patient Global Impression of Change (PGIC) as a primary endpoint for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME)-type Long COVID trials, drawing parallels to the regulatory pathway for cancer drugs.