TNXP stock closed Friday, July 23, 2021 at $0.98. Earlier in the morning session on Monday, TNXP shares lost 34.18% at $0.64. Tonix Pharmaceuticals Holding Corp. (TNXP) shares have fallen 35.10% over the last 12 months, and they have moved up 0.04% in the past week. Over the past three months, the stock has lost 5.77%, while over the past six months, it has shed 4.85%.
Let’s have a brief look at its recent news and developments.
Negative Results of Interim Analysis of Phase 3 Study of TNX-102 SL
On July 23, 2021, Tonix Pharmaceuticals Holding Corp (TNXP) 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.
IDMC recommended stopping the trial for futility, after the interim analysis results of the first 50% enrolled participants 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.
TNXP New board member appointment
Tonix Pharmaceuticals Holding Corp appointed Carolyn E. Taylor to its Board of Directors, effective as of July 16, 2021.
TNXP Inauguration to Russell 2000® and Russell 3000® Indexes
TNXP stock was added to the broad-market Russell 3000® index and the small-cap Russell 2000® Index, effective after the U.S. market opened on June 28, 2021, as part of the annual reconstitution of the Russell stock indexes.
Treatment for Long COVID Syndrome
On June 21, 2021, Tonix Pharmaceuticals Holding Corp (TNXP) announced its plans to develop TNX-102 SL (cyclobenzaprine HCl sublingual tablets) as a potential treatment for Long COVID Syndrome (Long COVID) which is now known officially as Post-Acute Sequelae of COVID-19 (PASC).
Tonix plans to meet with the U.S. Food and Drug Administration (FDA) in the third quarter of 2021 to seek agreement on the design of a potential Phase 2 pivotal study and the overall clinical development plan to qualify TNX-102 SL as an indicated treatment for Long COVID.
Participation in the conferences
Tonix (TNXP) recently participated in the BIO Digital Conference which was held on June 10-11 and 14-18, 2021. The company was presented by Seth Lederman, M.D., President and Chief Executive Officer of Tonix.
The company also participated in the Raymond James Human Health Innovation Conference which was held on June 23, 2021.
Conclusion
The company’s recent announcement about halting the enrolment in TNX-102 SL trials due to negative outcomes was the reason behind its significant loss on Friday. TNXP can continue to decline in the coming days as well.
