- Tonix Pharmaceuticals Holding Corp (NASDAQ: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.
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