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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.
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