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. (Nasdaq: TNXP) generates a steady flow of news as a fully integrated, commercial-stage biotechnology company with both marketed products and a broad development pipeline. News coverage for Tonix often centers on its FDA-approved fibromyalgia treatment TONMYA, its acute migraine products Zembrace SymTouch and Tosymra, and updates on clinical and regulatory milestones across central nervous system, immunology, rare disease and infectious disease programs.
Investors following TNXP news can expect announcements on commercial launches, market access decisions, and distribution arrangements for TONMYA, as well as prescription trends and formulary placements for its migraine therapies. The company also regularly reports progress on TNX-102 SL in indications such as acute stress-related conditions and major depressive disorder, including IND clearances and the design of potentially pivotal Phase 2 studies.
Tonix’s immunology and infectious disease work contributes additional news items, including collaborations with academic centers like Massachusetts General Hospital for TNX-1500 in kidney transplantation, and development plans for TNX-4800, a monoclonal antibody designed for seasonal prevention of Lyme disease. Licensing transactions, such as the acquisition of TNX-4900 for chronic neuropathic pain from Rutgers University, and government-supported projects like the DTRA-backed antiviral TNX-4200, are also common themes in company press releases.
This TNXP news page aggregates company-issued updates and related coverage so readers can quickly review developments in Tonix’s commercial operations, clinical pipeline, financing activities, and strategic collaborations. For investors and observers tracking biotech catalysts, revisiting this page provides a concise way to monitor how Tonix’s programs and capital markets actions evolve over time.
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.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) has initiated the PRECISION study to analyze immune responses to COVID-19. This observational study focuses on individuals who have recovered from COVID-19 or were asymptomatic, aiming to develop human monoclonal antibody therapeutics and identify biomarkers for protective immunity. The results are anticipated in the first half of 2021. Tonix's lead vaccine candidate, TNX-1800, aims to generate durable T cell immunity and may enhance participant selection for clinical trials. Data from this study is expected to inform future COVID-19 vaccine development.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced that President and CEO Seth Lederman will present at the 2020 BIO Investor Forum Digital from October 13-15, 2020. The presentation will be available on demand for registered participants. Tonix focuses on developing therapeutics for CNS and immunology, including the COVID-19 vaccine candidate TNX-1800 and TNX-102 SL for fibromyalgia. Expected data from animal studies and Phase 3 trials are anticipated in Q4 2020 and the second half of 2021, respectively. More details can be found at tonixpharma.com.
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