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 (TNXP) is a clinical-stage biopharmaceutical company developing innovative therapeutics for central nervous system disorders, immunology, and infectious diseases. This page provides timely updates on TNXP's clinical trials, regulatory milestones, and strategic initiatives.
Key resources for investors include press releases covering product development progress, partnership announcements, and financial reports. Our curated news collection helps track TNXP's pipeline candidates like TNX-102 SL for fibromyalgia and Tonmya™ for PTSD management.
Stay informed about developments in migraine therapeutics, rare disease research, and vaccine programs. Content categories include FDA communications, clinical trial results, intellectual property updates, and market expansion activities.
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Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced it will stop enrolling new participants in the Phase 3 RALLY study of TNX-102 SL (5.6 mg) for fibromyalgia management. This decision follows an interim analysis by the Independent Data Monitoring Committee (IDMC), indicating that the treatment is unlikely to show statistically significant improvements compared to placebo. The study initially enrolled 514 participants across 40 sites. Tonix plans to continue studying currently enrolled participants and expects to report topline results in Q4 2021.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced the appointment of Carolyn E. Taylor to its Board of Directors, effective July 16, 2021. Taylor brings over 35 years of corporate law experience, including 15 years as a partner at Covington & Burling LLP. CEO Seth Lederman expressed optimism about Taylor's broad transactional expertise contributing to the company's growth. Tonix focuses on developing treatments for CNS and immunology conditions, with key candidates including TNX-102 SL for fibromyalgia and TNX-1800 for COVID-19.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced its inclusion in the Russell 3000® and Russell 2000® indexes effective June 28, 2021. This addition reflects the company’s growth and achievements over the past year, as stated by CEO Seth Lederman. Russell indexes are crucial for investment managers, with about $10.6 trillion in assets benchmarked against them. Tonix focuses on developing CNS and immunology product candidates, with ongoing studies for fibromyalgia and vaccines targeting COVID-19 and smallpox.
Tonix Pharmaceuticals (Nasdaq: TNXP) plans to develop TNX-102 SL as a potential treatment for Long COVID, officially known as Post-Acute Sequelae of COVID-19 (PASC). Over 30% of COVID-19 patients develop chronic symptoms such as fatigue and brain fog. An FDA pre-IND meeting is scheduled for Q3 2021 to discuss the clinical development plan. TNX-102 SL is also in mid-Phase 3 for fibromyalgia, with results expected in Q3 2021 and Q1 2022. The drug aims to improve sleep quality, potentially addressing the core symptoms of Long COVID.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced that CEO Seth Lederman will present at the Raymond James Human Health Innovation Conference on June 23, 2021, at 8:00 a.m. ET. Investors can arrange virtual meetings through the conference coordinator. A webcast of the presentation will be accessible on Tonix's website. The company is focused on developing small molecules and biologics for CNS and immunology conditions. Its lead candidate, TNX-102 SL, is in mid-Phase 3 for fibromyalgia, with interim data expected in Q3 2021.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced that CEO Seth Lederman will participate in the BIO Digital Conference on June 10-11 and 14-18, 2021. The company's presentation will be available on demand for registered attendees. Tonix focuses on developing therapeutics for CNS and immunology, with lead candidates TNX-102 SL for fibromyalgia and TNX-1800 for COVID-19 vaccination. Interim results from their second Phase 3 study for TNX-102 SL are expected in Q3 2021.
Tonix Pharmaceuticals announced positive results from its Phase 3 RELIEF study of TNX-102 SL for fibromyalgia, significantly reducing daily pain compared to placebo (p=0.01) and improving key secondary endpoints like sleep quality and fatigue. The treatment was well tolerated, showing no side effects common with oral fibromyalgia treatments. The company expects interim analysis results for its ongoing confirmatory study, RALLY, in Q3 2021, followed by topline data in Q1 2022. TNX-102 SL has a favorable patent protection until 2034/2035.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced plans to present two posters at the 2021 ASCP Annual Meeting from June 1-4, 2021. The presentations will focus on TNX-102 SL for treating fibromyalgia and PTSD, showcasing results from their clinical trials. The first poster, on June 2, will detail a Phase 3 trial's positive results in fibromyalgia, while the second, on June 3, will analyze PTSD outcomes. Tonix aims to release interim data from its second Phase 3 study in Q3 2021 and topline data in Q1 2022.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced that CEO Seth Lederman will present at the Q2 Investor Summit Virtual Conference on May 17, 2021, at 3:30 p.m. ET. Investors can arrange virtual meetings with management through the conference coordinator. Tonix focuses on developing therapies for CNS and immunology, with lead candidates including TNX-102 SL for fibromyalgia and TNX-1800, a COVID-19 vaccine. Positive data from animal studies of TNX-1800 were reported in early 2021. Interim data from the RALLY study is expected in Q3 2021.
Tonix Pharmaceuticals (Nasdaq: TNXP) reported Q1 2021 financial results, achieving a cash balance of approximately $164 million, up from $77.1 million at the end of 2020. The company experienced a net loss of $20.7 million, or $0.07 per share, compared to $9 million a year prior. Key updates include positive animal study results for its COVID-19 vaccine candidate TNX-1800 and ongoing development of its CNS programs, with three entering Phase 2 trials this year. An interim analysis for its fibromyalgia treatment, TNX-102 SL, is expected in Q3 2021.