We are a fully-integrated biopharmaceutical company commercializing and developing innovative therapies for central nervous system disorders, immunology, and infectious diseases. We launched TONMYA (cyclobenzaprine HCl sublingual tablets) for fibromyalgia in adults in November 2025.
Kidney Transplant; Kidney Transplant Failure and Rejection; Immunosuppression
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Estimated readout windows: registry primary-completion date + 6-12 weeks. Windows already open are shown from "Now". Drug names link to ClinicalTrials.gov.
Status note FDA-approved, first new medicine for fibromyalgia in 15+ years. Potentially pivotal Phase 2 HORIZON study as first-line monotherapy in MDD; OASIS study for ASD/ASR funded by DoD grant.
TNX-4800
Phase 2 · ActiveModality: antibody
Aliases mAb 2217LS
Target Borrelia OspA
Partnerships UMass Chan Medical School (license)
Indications
Lyme disease prevention(Phase 2)
Catalysts
— first quarter of 2027
Status note Anti-Borrelia OspA human monoclonal antibody; Type C FDA meeting minutes support adaptive Phase 2 field study initiation.
TNX-1500
Phase 2 · ActiveModality: antibody
Target CD40L (CD154)
Partnerships Massachusetts General Hospital (investigator-initiated Phase 2)
Indications
Kidney transplant rejection(Phase 2)
Autoimmune diseases(Phase 2)
Status note Fc-modified humanized anti-CD40L (CD154) monoclonal antibody; Phase 2-ready for prevention of kidney transplant rejection and treatment of autoimmune diseases.
TNX-1300
Phase 2 · ActiveModality: enzyme
Aliases double-mutant cocaine esterase
Target cocaine
Partnerships NIH/NIDA (grant support)
Indications
Cocaine intoxication(Phase 2)
Status note FDA Breakthrough Therapy designation; Phase 2a in clinical development for cocaine intoxication.
Per-asset detail extracted from the 10-Q filed 2026-08-10. Fields the filing does not state are marked "not disclosed" rather than filled from other sources.
Pipeline
Lead drug
TNX-102 SL
Lead indication
Major Depressive Episode (MDE); Major Depressive Disorder (MDD); Depression
Sponsor-matched active trials from ClinicalTrials.gov (2 as sponsor, 4 as collaborator); "Sponsor" = company is the lead sponsor, "Collaborator" = company is a collaborator. The BP column flags big-pharma involvement as lead sponsor or collaborator (excluding the company itself). The Mgmt guide column shows what management guided for readout timing when a guided program matches the trial (hover for the quote, click for the source). Trial listings are not a company pipeline slide.