Tonix Pharmaceuticals Holding Corp. - TNXP STOCK NEWS

Tonix Pharmaceuticals (Nasdaq: TNXP) achieved target enrollment of approximately 470 participants in its Phase 3 RELIEF trial for TNX-102 SL, a non-opioid treatment for fibromyalgia, ahead of schedule. An interim analysis of 50% of participants is expected in September 2020, with topline data anticipated in Q4 2020. The RELIEF study is designed to assess the efficacy and safety of TNX-102 SL, with results expected to provide insights into a new treatment option for the fibromyalgia community.

Tonix Pharmaceuticals (Nasdaq: TNXP) announced plans to acquire a 40,000 sq. ft. facility in Massachusetts to establish an Advanced Development Center for R&D focused on immunology candidates, including vaccines for COVID-19. The new center will enhance Tonix's process and analytical development capabilities and is expected to be operational in 2022. Current collaborations with Southern Research and FUJIFILM Diosynth Biotechnologies for preclinical testing and manufacturing of TNX-801 and TNX-1800 vaccines will continue. Preclinical results for TNX-1800 are anticipated in Q4 2020.

Tonix Pharmaceuticals (Nasdaq: TNXP) announced accelerated enrollment for its Phase 3 RELIEF study of TNX-102 SL, aiming to report topline results in Q4 2020, earlier than previously expected. The study targets fibromyalgia, involving approximately 470 participants across 40 U.S. sites. An interim analysis of the first half of participants is anticipated in September 2020. This progress highlights Tonix’s efforts to provide a non-addictive treatment option for fibromyalgia, potentially addressing a significant market need.

Tonix Pharmaceuticals (Nasdaq: TNXP) announced an expansion of its collaboration with Southern Research to study T cell immune responses to SARS-CoV-2 in COVID-19 recovered or asymptomatic individuals. This research supports the development of TNX-1800, a live replicating virus vaccine aimed at eliciting T cell immunity. Data from this study will aid in interpreting upcoming animal trials and human studies. TNX-1800 aims for single-dose immunity without adjuvants and is expected to be manufactured on conventional systems, potentially allowing glass-sparing distribution.

Tonix Pharmaceuticals (Nasdaq: TNXP) announced that preclinical results of TNX-1700 will be presented at the AACR Virtual Annual Meeting II from June 22-24, 2020. The poster titled ‘Stabilized recombinant trefoil factor 2 (TFF2-CTP) enhances anti-tumor activity of PD-1 blockade in mouse models of colorectal cancer’ will showcase the enhancement of PD-1 blockade efficacy in colorectal cancer. The company focuses on developing drugs in CNS and immunology with ongoing programs like TNX-102 SL for fibromyalgia and TNX-1800 for COVID-19 protection, expecting data in Q4 2020.

Tonix Pharmaceuticals (Nasdaq: TNXP) announced the acquisition of migraine and pain treatment technologies from Trigemina, Inc., along with a license from Stanford University. The main asset, TNX-1900, is an intranasal oxytocin solution with promising preclinical results in migraine prevention and pain management. Tonix aims to position TNX-1900 as a non-addictive alternative to opioids. With oxytocin linked to reduced headache frequency, the targeted delivery method may enhance efficacy and safety, making it a notable asset in their portfolio.

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced participation in two virtual investor conferences in June 2020. The first event, 2020 BIO Digital, will be held from June 8-12, with presentations available on demand. The second event is the Virtual Summer Summit on June 10, where Tonix's presentation is scheduled for 2:45 p.m. ET. The company focuses on developing drugs for pain, psychiatric conditions, and infectious diseases, including a COVID-19 vaccine candidate, TNX-1800. Tonix’s advanced treatments target fibromyalgia and PTSD, with important trial results expected soon.

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) has partnered with FUJIFILM Diosynth Biotechnologies to enhance the manufacturing of its COVID-19 vaccine candidate, TNX-1800. This collaboration aims to utilize FDB's advanced manufacturing capabilities to support clinical trials. CEO Seth Lederman emphasized the potential scalability of their live replicating orthopoxvirus vaccine. The agreement will see FDB develop a manufacturing process and supply TNX-1800 for clinical development at its Texas site, aiming to meet pandemic demands efficiently.

Tonix Pharmaceuticals (Nasdaq: TNXP) announced the presentation of two pharmacokinetic studies at the ASCP 2020 Annual Meeting held online on May 29-30. One study focused on TNX-102 SL, a potential treatment for fibromyalgia and PTSD, showing dose-proportional absorption without food effects. The other study evaluated TNX-601 CR, a once-daily formulation for major depressive disorder and PTSD, demonstrating suitability for once-daily dosing and good tolerability. The company continues to advance its drug candidates, with key trial results expected soon.