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Tonix Pharmaceuticals Holding (TNXP) investor relations material
Tonix Pharmaceuticals Holding Corporate Presentation summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
Strategic focus and mission
Aims to address unmet needs in chronic pain, immunology, infectious disease, and rare diseases through in-house R&D and collaborations.
Operates a fully integrated biotech platform with commercial, clinical, and preclinical programs across CNS, immunology, and infectious disease portfolios.
Commercial portfolio and product highlights
TONMYA, a sublingual cyclobenzaprine HCI tablet, received FDA approval on August 15, 2025, for fibromyalgia; US launch planned for Q4 2025.
TOSYMRA and ZEMBRACE, both non-oral sumatriptan formulations, are available for acute migraine treatment.
TONMYA is the first FDA-approved fibromyalgia treatment in over 15 years, offering a unique, non-opioid, first-line therapy.
Market opportunity and patient needs
Over 10 million US adults affected by fibromyalgia, with high dissatisfaction and failure rates for existing therapies.
85% of first-line treatments fail; 79% of patients use multiple therapies, and significant off-label opioid use is reported.
~5% of HCPs write 70% of fibromyalgia prescriptions, guiding a hyper-focused HCP engagement strategy.
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