Welcome to our dedicated page for Tonix Pharmaceut news (Ticker: TNXP), a resource for investors and traders seeking the latest updates and insights on Tonix Pharmaceut stock.
Tonix Pharmaceuticals Holding Corp. develops and commercializes biotechnology products for central nervous system disorders, immunology, infectious diseases and rare diseases. Company news centers on TONMYA, an FDA-approved cyclobenzaprine HCl sublingual tablet for fibromyalgia in adults, along with marketed acute migraine products Zembrace SymTouch and Tosymra.
Recurring updates also cover Tonix’s development pipeline, including TNX-4800, a long-acting anti-Borrelia OspA human monoclonal antibody for Lyme disease prophylaxis; TNX-1900 intranasal potentiated oxytocin for craniofacial pain conditions; TNX-1700 and TNX-4700 immuno-oncology programs; TNX-801 vaccine research; and TNX-1500 for prevention of kidney transplant rejection. Other company developments include scientific presentations, clinical and preclinical data, commercial access arrangements, operating results, capital-structure disclosures and governance matters.
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.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced that all eight non-human primates vaccinated with TNX-1800, a modified horsepox virus COVID-19 vaccine candidate, developed neutralizing antibodies and manifested a skin reaction known as 'take', indicating a strong T cell immune response. The study showed TNX-1800's safety and its potential as a single-dose vaccine, which could simplify distribution. The company plans to advance to human Phase 1 trials in 2021, with manufacturing support from FUJIFILM Diosynth Biotechnologies. Preliminary results suggest TNX-1800 could provide long-term immunity against COVID-19.
Tonix Pharmaceuticals (Nasdaq: TNXP) is addressing the increasing placebo responses in PTSD drug trials, which complicate the effectiveness of treatments. CEO Seth Lederman presented a new statistical method, RHNPCOT, at the Neuropsychiatric Drug Development Summit, showing improved analytics for the Phase 3 HONOR study of TNX-102 SL. The company plans a Phase 3 study in Kenya targeting police, expected to begin in Q3 2021. Tonix is also preparing to unblind data from the RECOVERY study by year-end, which may validate the new method.
Tonix Pharmaceuticals (NASDAQ:TNXP) will participate in the 2020 Fall Investor Summit from November 16-18. This virtual event will feature 75 companies and over 300 investors, creating a platform for networking and investment opportunities.
Tonix is focused on developing treatments for human diseases, particularly in the central nervous system and immunology fields. Their lead vaccine candidate, TNX-1800, aims to protect against COVID-19, with data expected in 4Q'20. Additionally, their CNS candidate, TNX-102 SL, is in Phase 3 trials for fibromyalgia, with results anticipated later this year.
Tonix Pharmaceuticals (Nasdaq: TNXP) has announced that its CEO, Seth Lederman, is set to present at three virtual investor conferences this November. The details of the events are as follows:
- Virtual Fall Investor Summit: November 16, 2020, at 1:30 p.m. ET
- Sidoti Virtual Microcap Conference: November 19, 2020, at 8:30 a.m. ET
- A.G.P Virtual Healthcare Symposium: November 19, 2020, featuring a panel on COVID-19 vaccines.
Webcasts will be available on the company's website post-event.