TNXP Tonix

TNX-102 SL · NCT06636786 registry update

primary_completion: 2026-09 → 2026-11; completion: 2026-09 → 2026-11

Tonix Receives Paragraph IV Notice from Dr. Reddy’s on TONMYA ANDA

Dr. Reddy’s Laboratories filed an ANDA with Paragraph IV certification challenging Tonix’s Orange Book patents for TONMYA. Filing of a patent infringement suit within 45 days would trigger a 30-month FDA approval stay on the generic application. Tonix intends to enforce its patents but cannot predict litigation outcome or timing of potential generic competition.

TNX-102 SL · NCT07621237 registry update

countries: {'total_sites': 25, 'us_sites': 25} → {'total_sites': 27, 'us_sites': 27}

Tonix Pharmaceuticals Announces Second Major Managed Medicare Payer Agreement for TONMYA

Tonix announced a new managed Medicare payer agreement effective immediately that adds approximately 21 million Medicare lives, bringing total Medicare coverage for TONMYA to 32 million lives (58% of U.S. Medicare population) and overall U.S. commercial/government coverage to 166 million lives (53% of total U.S. population). TONMYA (cyclobenzaprine HCl sublingual tablets) was previously approved by the FDA on August 15, 2025 for the treatment of fibromyalgia in adults. This expands payer access but does not alter the regulatory label or approval status.

Tonix: FDA approves TONMYA (cyclobenzaprine HCl) for fibromyalgia

FDA granted approval of TONMYA for fibromyalgia in adults in August 2025, the first new medicine for this indication in >15 years. The product launched commercially on November 17, 2025, with early uptake showing >1,500 prescribers and ~4,200 prescriptions by late February 2026.

Tonix licenses TNX-4900 Sigma-1 antagonist for neuropathic pain

Tonix acquired exclusive worldwide rights to TNX-4900, a selective Sigma-1 receptor antagonist, from Rutgers University. The asset has shown efficacy in diabetic and chemotherapy-induced neuropathic pain models and is advancing toward IND-enabling studies. No regulatory filing or clinical timeline is stated in the release.

Tonix completes Pre-IND meeting for TNX-102 SL in MDD; IND filing planned Q4 2025

Tonix completed a Type B Pre-IND meeting with the FDA for TNX-102 SL in major depressive disorder and received positive feedback. The FDA found the proposed long-term safety data collection plan generally reasonable, potentially streamlining the development path. The company plans to file an IND in Q4 2025 and pursue an sNDA to expand the indication from fibromyalgia to MDD.