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. 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.
The FDA has granted Fast Track designation to Tonix Pharmaceuticals (NASDAQ:TNXP) for TNX-102 SL, a drug candidate for managing fibromyalgia. This recognition underscores fibromyalgia as a serious condition affecting over 10 million Americans. The global fibromyalgia treatment market is projected to reach $3.86 billion by 2031, growing at a 3.3% CAGR. TNX-102 SL, a non-addictive sublingual formulation of cyclobenzaprine hydrochloride, showed significant improvement in fibromyalgia pain in Phase 3 trials. Tonix plans to submit a New Drug Application (NDA) in the second half of 2024, potentially becoming the first new fibromyalgia pharmacotherapy in over 15 years.
Tonix Pharmaceuticals (TNXP) reports potential positive impact on the fibromyalgia market for Tonmya™ due to the new definition of Long COVID by the U.S. National Academies (NASEM). Key points:
1. Fibromyalgia is now recognized as a 'diagnosable condition' in Long COVID patients.
2. This may expand the addressable market for Tonmya beyond pre-pandemic estimates.
3. Tonmya, a non-opioid analgesic for fibromyalgia, has Fast Track designation.
4. NDA submission target: second half of 2024, potential FDA approval in 2025.
5. Estimated 14 million U.S. adults suffer from Long COVID, with over 40% potentially presenting fibromyalgia-like symptoms.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced a poster presentation at the IASP 2024 World Congress on Pain, highlighting statistically significant Phase 3 results of Tonmya™ for fibromyalgia management. The presentation, scheduled for August 7, 2024, will focus on targeting non-restorative sleep with TNX-102 SL, showing consistent syndromic improvement. Tonmya has received FDA Fast Track Designation, and Tonix plans to submit a New Drug Application (NDA) in the second half of 2024.
Tonix is developing a portfolio of central nervous system (CNS) disorders treatments, including TNX-1300 for cocaine intoxication with Breakthrough Therapy designation. The company also has immunology and rare disease candidates in development. Tonix Medicines, their commercial subsidiary, markets Zembrace® SymTouch® and Tosymra® for acute migraine treatment.
Tonix Pharmaceuticals (Nasdaq: TNXP) has received Fast Track designation from the FDA for Tonmya™, its non-opioid analgesic drug for fibromyalgia. This designation recognizes fibromyalgia as a serious condition affecting over 10 million U.S. adults and aims to expedite FDA review. Tonix plans to submit a New Drug Application (NDA) in the second half of 2024, with potential market entry in 2025. If approved, Tonmya could be the first new fibromyalgia drug in over 15 years. The company is positioning Tonmya as a first-line, long-term daily treatment option. Fast Track status allows for more frequent FDA interactions and the possibility of Priority Review, potentially accelerating the approval process.
Tonix Pharmaceuticals (NASDAQ:TNXP) has secured up to $34 million in funding from the U.S. Department of Defense to develop broad-spectrum antiviral agents. The five-year deal with the Defense Threat Reduction Agency (DTRA) aims to improve the medical readiness of military personnel in biological threat environments. Tonix's program will focus on optimizing TNX-4200, an oral CD45 antagonist designed for broad-spectrum efficacy against various viral pathogens.
The company plans to leverage its research facilities, including a BSL-3 lab and ABSL-3 facility in Maryland, to accelerate development. This funding validates Tonix's ongoing research and in-house capabilities, supporting the advancement of its antiviral discovery program beyond the traditional 'one bug, one drug' approach.
Tonix Pharmaceuticals (NASDAQ:TNXP) is preparing to file a New Drug Application (NDA) for Tonmya, its fibromyalgia management drug, in the second half of 2024. The company anticipates FDA approval and commercial launch in the second half of 2025. Tonmya, a non-opioid sublingual tablet, has shown significant improvements in fibromyalgia pain, sleep quality, and other symptoms in clinical trials.
The fibromyalgia market, valued at over $3 billion globally in 2023, has not seen a new FDA-approved drug in over 15 years. Tonix aims to compete in this growing market, which is expected to expand at a 3.8% CAGR from 2024 to 2030. With Tonmya's unique mechanism of action and promising clinical results, Tonix is positioned to potentially disrupt the market currently dominated by generic versions of previous blockbuster drugs.
Tonix Pharmaceuticals (Nasdaq: TNXP) has announced the closing of a $4.0 million public offering. This included 3,393,600 shares of common stock and pre-funded warrants for 3,703,140 shares, priced at $0.57 per share and $0.569 per warrant. The gross proceeds from this offering total $4.0 million, before deducting fees and other expenses. The company plans to use the net proceeds for working capital, general corporate purposes, and to prepare the new drug application for its Tonmya product candidate for fibromyalgia. Dawson James Securities acted as the sole placement agent for this offering. The offering was made under an effective shelf registration statement and filed with the SEC.
Tonix Pharmaceuticals announced a public offering valued at approximately $4.0 million. The firm will issue 7,096,740 shares of common stock at $0.57 per share or pre-funded warrants at $0.569 per warrant. The offering is set to close on July 10, 2024, pending standard conditions. The net proceeds will support general corporate purposes, including preparing a New Drug Application for Tonmya™ and managing existing debt. Dawson James Securities, Inc. is the sole placement agent. The offering follows a shelf registration statement on Form S-3 already filed with the SEC.
Tonix Pharmaceuticals announced a proposed public offering of its common stock or pre-funded warrants. The proceeds will be used for working capital, general corporate purposes, including a new drug application for their product candidate Tonmya™, targeting fibromyalgia, and to address existing debt. Dawson James Securities is the sole placement agent. The offering is subject to market conditions and the terms remain unspecified. The offering is based on an effective shelf registration statement previously filed with the SEC. Investors are encouraged to read the entire prospectus supplement and accompanying documents for more information.
Tonix Pharmaceuticals announced the receipt of formal minutes from a pre-New Drug Application (NDA) meeting with the FDA for Tonmya™ (cyclobenzaprine HCl sublingual tablets), a potential first-line non-opioid treatment for fibromyalgia. The FDA agreed that the proposed data package is sufficient for the NDA submission, which Tonix plans to submit in the second half of 2024, aiming for potential approval by the second half of 2025. The announcement emphasizes Tonmya's potential to benefit fibromyalgia patients, many of whom are dissatisfied with current treatments and often resort to opioids.