Welcome to our dedicated page for Tonix Pharmaceuticals Holding news (Ticker: TNXP), a resource for investors and traders seeking the latest updates and insights on Tonix Pharmaceuticals Holding stock.
Tonix Pharmaceuticals Holding Corp. (symbol: TNXP) is a pioneering biopharmaceutical company dedicated to developing, licensing, and commercializing innovative therapeutics to treat and prevent human diseases. With a focus on central nervous system (CNS) disorders, Tonix is at the forefront of addressing major public health challenges.
One of Tonix's key projects is Tonmya, aimed at treating PTSD, which is currently in advanced stages of development. Additionally, the company is working on TNX-601 (tianeptine oxalate), a daytime treatment for PTSD, and TNX-801, a synthetic version of the horsepox virus, intended as a potential smallpox vaccine, both at the pre-IND (Investigational New Drug) application stage.
The company’s immunology development portfolio includes TNX-1500, a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154), being developed to prevent allograft rejection and treat autoimmune diseases. This portfolio demonstrates Tonix's commitment to addressing both organ transplant rejection and autoimmunity, as well as cancer.
Tonix’s mission to alleviate suffering extends beyond CNS disorders and immunology, as it is also exploring therapeutic solutions for rare and infectious diseases. Their dedication to research and innovation has established partnerships with reputable institutions, such as Massachusetts General Hospital, ensuring that their projects are backed by cutting-edge science and expertise.
For more information, visit Tonix Pharmaceuticals Holding Corp.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced that its President and CEO, Seth Lederman, will present at the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, 2021. Interested investors may arrange virtual meetings with management. A webcast of the presentation will be available on-demand starting September 13, 2021, at 7:00 a.m. on the Tonix website, with a replay accessible for 90 days. Tonix focuses on developing therapies in CNS and immunology, including lead candidates for fibromyalgia and COVID-19 vaccines.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced plans to submit an Investigational New Drug (IND) application in Q4 2021 for TNX-102 SL as a treatment for Long COVID, focusing on patients with symptoms overlapping fibromyalgia. The FDA has provided guidance on the Phase 2 study design following a Type B pre-IND meeting. Long COVID affects over 30% of COVID-19 patients and can lead to persistent symptoms such as fatigue and pain. The company aims to leverage insights from its mid-Phase 3 fibromyalgia trials to inform this new treatment approach.
Tonix Pharmaceuticals (Nasdaq: TNXP) reported its Q2 2021 financial results, highlighting ongoing clinical trials for TNX-1300 and TNX-1900, and a Phase 3 study for TNX-102 SL. The company aims to enhance R&D and manufacturing capabilities with new facilities and expects a cash balance of approximately $166 million as of June 30, 2021. Research and development expenses rose to $18.1 million, while the net loss was $23.6 million, or $0.07 per share. The company’s focus includes advancing COVID-19 product candidates and expanding its CNS pipeline.
Tonix Pharmaceuticals announced a groundbreaking ceremony for its new Advanced Development Center (ADC) in New Bedford, MA, scheduled for August 3, 2021. The 45,000 sq. ft. facility will enhance the company's capacity for vaccine development, focusing on infectious diseases, including COVID-19. It aims to be operational in the first half of 2022 and will employ up to 70 staff. The ADC will support clinical manufacturing under Good Manufacturing Practices (GMP) and is a significant step toward addressing public health challenges.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced the acquisition of a 48,000 square foot R&D facility in Frederick, MD, from Southern Research. This facility will expand Tonix's capabilities in developing vaccines and antiviral drugs, specifically against COVID-19 and other infectious diseases. The acquisition aims to enhance the production and efficiency of Tonix’s vaccine candidates, including TNX-1800 and TNX-801. Expected to close by Q4 2021, this strategic move addresses challenges revealed by the COVID-19 pandemic and positions Tonix within Maryland’s biotech corridor.
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.
FAQ
What is the current stock price of Tonix Pharmaceuticals Holding (TNXP)?
What is the market cap of Tonix Pharmaceuticals Holding (TNXP)?
What is the main focus of Tonix Pharmaceuticals Holding Corp.?
What is Tonmya?
What are TNX-601 and TNX-801?
What is TNX-1500?
Which institutions is Tonix Pharmaceuticals affiliated with?
How can I get more information about Tonix Pharmaceuticals?
What areas of disease does Tonix Pharmaceuticals focus on?
What stage are TNX-601 and TNX-801 in?
Who can I contact for investor relations at Tonix Pharmaceuticals?
Who can I contact for media inquiries at Tonix Pharmaceuticals?
