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) 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.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced that CEO Seth Lederman will speak at the 3rd Annual Neuropsychiatric Drug Development Summit, virtually held from November 10-12, 2020. Dr. Lederman's presentation is set for November 12 at 11:55 a.m. ET, focusing on developing a PTSD therapeutic in Phase 3 clinical development. An archived replay of the presentation will be available on the company's website after the event. The summit aims to address challenges in developing neuropsychiatric drugs, spotlighting innovations in clinical trial design and treatment options.
Tonix Pharmaceuticals (Nasdaq: TNXP) reported Q3 2020 financial results, highlighting a net loss of $12 million, or $0.09 per share, up from a $7.8 million loss in Q3 2019. The company has $55.7 million in cash and equivalents, a significant increase from $11.2 million at the end of 2019. Key developments include advancing its COVID-19 vaccine candidate TNX-1800, with data from animal studies expected by year-end 2020, and a Phase 1 human study anticipated in 2021. Tonix is also progressing with other potential therapies and expansion in Massachusetts.