Tonix Pharmaceuticals announced first patient enrolled in the potentially pivotal Phase 2 HORIZON study of TNX-102 SL for major depressive disorder.

Key Highlights:

  • First participant enrolled in HORIZON, a randomized, double-blind, placebo-controlled Phase 2 trial of TNX-102 SL 5.6 mg for MDD.
  • Study is 6 weeks, aims to enroll ~360 patients at ~30 U.S. sites; primary endpoint is change in MADRS total score at Week 6.
  • TNX-102 SL targets sleep quality via multi-receptor antagonism; company cites prior signals in PTSD and fibromyalgia studies.
  • TNX-102 SL is FDA-approved for fibromyalgia (TONMYA) and has U.S. patents expected to provide market exclusivity through 2034.

Original SEC Filing:

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