Tonix Pharma Deprioritizes COVID-19 Related Programs, Pending PTSD Trial

  • Tonix Pharmaceuticals Holding Corp TNXP will reallocate resources and cash to streamline its pipeline and focus on its mid and late-stage clinical programs within its core central nervous system (CNS) portfolio. 
  • The pipeline realignment reduces investment in several longer-term programs, particularly COVID-19-related studies, and delays the start of a posttraumatic stress disorder (PTSD) study in Kenya.
  • The company is discontinuing the enrollment of new patients in the Phase 2 trial in fibromyalgia-type Long COVID. The approximately 60 patients enrolled will be followed to completion, with topline data expected in Q3 of 2023.
  • Also See: Tonix Pharmaceuticals Seeks To Bolster Its COVID-19 Pipeline With This New Acquisition.
  • 2023 Catalysts:
    • Interim analysis results of Phase 3 RESILIENT study of TNX-102 SL (sublingual cyclobenzaprine tablets) for fibromyalgia are expected in Q2 of 2023, and topline results are expected in Q4 of 2023.
    • Interim analysis results of Phase 2 PREVENTION study of TNX-1900 (intranasal potentiated oxytocin) for chronic migraine anticipated in Q4 2023.
    • Interim analysis results of Phase 2 UPLIFT study of TNX-601 ER (tianeptine hemioxalate extended-release tablets) for major depressive disorder in the fourth quarter of 2023.
  • Cash and cash equivalents of approximately $120.2 million as of Dec. 31, 2022.
  • Price Action: TNXP shares are down 1.56% at $0.57 on the last check Tuesday.
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