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.
Tonix Pharmaceuticals has announced key findings from the initial phase of EVERSANA's market analysis for Tonmya, a potential first-line, non-opioid treatment for fibromyalgia. The report reveals high interest in Tonmya among primary care physicians and significant dissatisfaction with current FDA-approved drugs. Opioids are frequently prescribed despite their risks. Tonmya has shown promising results in two Phase 3 trials, reducing pain and improving sleep and overall symptoms. Tonix aims to submit an NDA to the FDA in the second half of 2024, with an anticipated launch in 2025.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced that CEO Seth Lederman will participate virtually in a fireside chat at the A.G.P. Healthcare Company Showcase on May 21, 2024, at 9:00 a.m. ET.
The presentation will be live webcast and available for replay on the Tonix website.
Tonix is a biopharmaceutical company focused on developing therapeutics for CNS disorders, including submitting a New Drug Application (NDA) for Tonmya in the second half of 2024.
Other key products in their portfolio include TNX-1300 for cocaine intoxication and TNX-1500 for organ transplant rejection and autoimmune diseases. Tonix also markets Zembrace SymTouch and Tosymra for acute migraine treatment.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced its Q1 2024 financial results and operational highlights. The company is preparing to submit a New Drug Application (NDA) for Tonmya™ for fibromyalgia by H2 2024, with FDA approval expected in H2 2025. Tonmya, a non-opioid analgesic, has shown efficacy in Phase 3 trials without common side effects. Net revenue for Q1 2024 was $2.5 million, with a net loss of $14.9 million. Other key programs include treatments for PTSD, Long COVID, cocaine intoxication, and rare diseases. Cash and equivalents were $7.0 million as of March 31, 2024.
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