TNXP Stock Falls Over 30% Pre-Market: Why It Happened

By Amit Chowdhry ● Jul 26, 2021
  • The stock price of Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) fell by over 30% pre-market. This is why it happened.

The stock price of Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) fell by over 30% pre-market. Investors are responding negatively to Tonix Pharmaceuticals announcing that they have decided to stop enrollment in the Phase 3 RALLY study of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg for the management of fibromyalgia following an unblinded, pre-planned interim analysis by the Independent Data Monitoring Committee (IDMC) of the RALLY study. 

Based on the interim analysis results of the first 50% (n=337) enrolled participants, the IDMC recommended stopping the trial for futility as TNX-102 SL is unlikely to demonstrate a statistically significant improvement in the primary endpoint of overall change from baseline in daily diary pain severity scores between those treated with TNX-102 SL 5.6 mg (2x 2.8 mg tablets) and those receiving placebo. And Tonix remains blinded to the detailed interim analysis results and only received the recommendation made by the IDMC. 

The preliminary blinded safety data from these participants did not reveal any new safety signals and the decision to discontinue enrolling new participants is not related to safety. And the company plans to continue studying those participants currently enrolled until completion and then proceed with a full analysis of the unblinded data with the topline results expected to be reported in the fourth quarter of 2021 to determine the next steps in this program.

KEY QUOTE:

“We are surprised and disappointed that the interim analysis did not support continued enrollment in this Phase 3 RALLY study, especially considering the previous Phase 3 RELIEF study, which had a similar design and achieved statistical significance on the primary endpoint. After the currently enrolled participants complete the study, we will proceed with a full analysis of the unblinded data from the study to determine the next steps in this program. These results underscore the difficulty in managing and treating fibromyalgia. We thank the patients, caregivers and investigators who participated in the RALLY study.”

— Seth Lederman, M.D., President and Chief Executive Officer

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