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IDMC Recommends Tonix Pharma To Stop Enrollment In Fibromyalgia Trial; Shares Drop

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  • Following an unblinded, pre-planned interim analysis by the Independent Data Monitoring Committee (IDMC), Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) will stop enrollment in the Phase 3 RALLY study of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg for fibromyalgia.

  • The IDMC recommended stopping the trial for futility as TNX-102 SL is unlikely to demonstrate a statistically significant improvement in overall change from baseline in pain (primary endpoint) compared to placebo.

  • Tonix remains blinded to the detailed interim analysis results and only received the recommendation.

  • Preliminary blinded safety data did not reveal any new safety signals, and the decision to discontinue enrollment is not related to safety.

  • The company intends to continue studying those enrolled participants until completion and then proceed with a full analysis of the unblinded data.

  • Topline results are expected in Q4 of 2021.

  • Price Action: TNXP shares are down 34.2% at $0.65 during the premarket session on the last check Monday.

  • Related content: Benzinga's Full FDA Calendar.

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