Tonix Pharmaceuticals Holding Corp. - TNXP STOCK NEWS

Tonix Pharmaceuticals Holdings Corp. (NASDAQ: TNXP) announced the completion of a registered direct offering, generating gross proceeds of $40 million. The company sold 50 million shares at $0.80 per share, facilitated by A.G.P./Alliance Global Partners as the sole placement agent. This offering utilized effective shelf registration statements previously filed with the SEC. Tonix, focused on developing CNS and immunology therapeutics, is advancing its lead candidate, TNX-102 SL, through mid-Phase 3 trials and anticipates interim results in Q2 2021.

Tonix Pharmaceuticals Holdings Corp. (NASDAQ: TNXP) announced a registered direct offering of 50 million shares at $0.80 per share, generating gross proceeds of $40 million before expenses. Closing is expected by January 13, 2021, pending customary conditions. The offering will utilize effective shelf registration statements filed with the SEC. Tonix focuses on developing treatments for central nervous system and immunology conditions, with ongoing clinical trials, including the mid-Phase 3 study for TNX-102 SL for fibromyalgia and TNX-1800, a COVID-19 vaccine candidate.

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced that CEO Seth Lederman will present at four virtual conferences from January 11 to January 14, 2021. These events include the H.C. Wainwright BioConnect Conference and the Biotech Showcase 2021, both offering on-demand presentations. The Sidoti Winter Virtual Investor Conference is scheduled for January 13, 2021, at 9:15 a.m. ET, followed by the ICR Conference 2021 on January 14, 2021, also at 9:15 a.m. ET. Webcasts will be available on the company’s website.

Tonix Pharmaceuticals (Nasdaq: TNXP) has expanded its collaboration with Massachusetts General Hospital to further research TNX-1500, a monoclonal antibody aimed at preventing organ transplant rejection. The new focus will be on kidney transplantation, building on existing studies in heart transplantation. TNX-1500 is designed to target CD40-ligand and reduce the risk of thrombosis associated with previous generations. The company emphasizes the potential of TNX-1500 in treating autoimmune diseases, including rheumatoid arthritis and systemic lupus erythematosus.

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) has acquired a 44-acre site in Hamilton, Montana, to build a commercial-scale vaccine manufacturing facility. This site complements their 40,000 square foot Advanced Development Center in Massachusetts. The facilities aim to support the development of Tonix's COVID-19 vaccine candidate, TNX-1800, and other vaccines. CEO Seth Lederman emphasizes the need for U.S.-based vaccine production post-pandemic. Tonix's approach involves live-virus vaccines for durable immunity. Efficacy data is expected in early 2021.

Tonix Pharmaceuticals (Nasdaq: TNXP) announced the acquisition of an exclusive license for technology from the University of Geneva that uses oxytocin to treat insulin resistance and obesity, through Katana Pharmaceuticals. This agreement enhances Tonix's TNX-1900 program by addressing cardiometabolic syndromes and provides patent protection until 2031 in the U.S. and Europe. The technology showed promise in improving lipid metabolism and insulin sensitivity, with potential applications for treating chronic migraines.

Tonix Pharmaceuticals announced topline results from its Phase 3 RECOVERY study of TNX-102 SL for treating PTSD. The primary endpoint did not achieve statistical significance (P=0.343), consistent with interim analysis. However, secondary endpoints showed encouraging activity with improvements in Clinical Global Impression - Severity (P=0.024) and Patient Global Impression of Change (P=0.007). The treatment was well tolerated without new safety signals. The company plans to pursue TNX-102 SL for sleep disturbance in PTSD, a prevalent condition affecting nearly 12 million adults in the U.S.

Tonix Pharmaceuticals (Nasdaq: TNXP) announced that its drug TNX-102 SL achieved a statistically significant pain reduction of p=0.01 in fibromyalgia patients during the Phase 3 RELIEF study. The trial involved 503 participants and demonstrated TNX-102 SL's potential to improve sleep and reduce fatigue. The company plans to submit a New Drug Application (NDA) to the FDA in 2022 if the ongoing RALLY study yields favorable results. The 5.6 mg dose was well tolerated, with no new safety signals reported, highlighting its promise as a non-opioid treatment for fibromyalgia.

Tonix Pharmaceuticals (Nasdaq: TNXP) communicates significant findings regarding its experimental vaccines based on horsepox. Published in Genome Biology, researchers reported a 99.7% genomic identity between a 1860 smallpox vaccine and horsepox, suggesting historical use of horsepox as a safe smallpox vaccine. Tonix's TNX-801, a horsepox-based live virus vaccine, aims to prevent smallpox and monkeypox, while TNX-1800, also derived from horsepox, targets COVID-19 by eliciting T cell responses. These findings enhance the understanding of vaccine development and efficacy.