Tonix Pharmaceuticals Fast Forwards Its Fibromyalgia, Migraine Studies

Tonix Pharmaceuticals Holding Corp TNXP has eliminated the interim analyses in its registration-enabling, confirmatory Phase 3 RESILIENT study of TNX-102 SL for fibromyalgia and its Phase 2 PREVENTION study of TNX-1900 for chronic migraine.
Interim analyses were expected in Q2 and Q4 of 2023, respectively.
The modifications to the RESILIENT and PREVENTION studies are designed to streamline the trials and to provide topline data for both programs in 2023.
Related: Tonix Pharma Deprioritizes COVID-19 Related Programs, Pending PTSD Trial.
Target enrollment for the core TNX-102 SL fibromyalgia study remains at approximately 470 participants, while target enrollment for the TNX-1900 chronic migraine study will be reduced from approximately 300 participants to approximately 150 participants to accommodate the new topline timing.
Topline results are expected in the fourth quarter of 2023.
Topline results of Phase 2 PREVAIL study of TNX-102 SL for fibromyalgia-type Long COVID is expected in Q3 of 2023.
Price Action: TNXP shares are down 3.06% at $0.54 on the last check Thursday.