Benzinga | Jul 26, 2021 06:41AM EDT

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

* 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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