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 changes to streamline its clinical trials for fibromyalgia and chronic migraine. The company will eliminate interim analyses in the Phase 3 RESILIENT study of TNX-102 SL for fibromyalgia and the Phase 2 PREVENTION study of TNX-1900 for chronic migraine. These modifications aim to expedite timelines, with topline results expected in Q4 2023. Target enrollment for the fibromyalgia study remains at approximately 470 participants, while the chronic migraine study's enrollment has been reduced from 300 to 150 participants. CEO Seth Lederman emphasized the commitment to advancing these central nervous system programs closer to FDA approval.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced promising preclinical results for its vaccine candidate, TNX-801, designed to combat mpox and smallpox. Presented at the World Vaccine Congress, TNX-801 demonstrated full protection against lethal challenges in non-human primates, indicating strong efficacy. The CEO emphasized TNX-801's potential for widespread use without the need for cold storage. A Phase 1 trial for TNX-801 is slated to begin in the second half of 2023. Additionally, TNX-1800, another vaccine candidate targeting SARS-CoV-2, showed effectiveness in protecting airways in animal models. Tonix is committed to developing robust vaccines for emerging infectious diseases, contributing to public health security.
Tonix Pharmaceuticals (NASDAQ: TNXP) will present two posters at the AACR Annual Meeting from April 14-19, 2023, in Orlando, FL. The research focuses on TNX-1700, a recombinant TFF2-albumin fusion peptide, showing effectiveness in targeting myeloid-derived suppressor cells (MDSCs) in murine colorectal and gastric cancer models. The studies highlight the additive benefits of mTNX-1700 combined with PD-1 blockade therapy. Additional details and poster copies will be available on the company’s website following the conference.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced a strategic realignment of its resources, prioritizing clinical-stage CNS programs for fibromyalgia, migraine, and depression while deprioritizing COVID-19-related projects. As of December 31, 2022, the company reported approximately $120.2 million in cash and cash equivalents. Key anticipated milestones for 2023 include interim analyses for Phase 3 fibromyalgia trials and Phase 2 studies for chronic migraine and depression. The company is also discontinuing new patient enrollment in a Phase 2 trial for fibromyalgia-type Long COVID. Tonix remains focused on maximizing value from its core CNS portfolio.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced key findings from the Phase 3 RELIEF trial for TNX-102 SL, showing significant pain reduction in fibromyalgia patients compared to placebo (p=0.01). The drug also demonstrated improved sleep quality and reduced fatigue, with 47% of participants responding positively to treatment. The interim analysis of its RESILIENT Phase 3 trial is anticipated in Q2 2023, with topline data expected in Q4 2023. TNX-102 SL's favorable safety profile includes similar discontinuation rates between treatment and placebo. The need for new fibromyalgia treatments remains critical.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced key presentations at the upcoming World Vaccine Congress in Washington D.C. from April 3-6, 2023. Dr. Zeil Rosenberg will discuss a live attenuated horsepox vaccine for mpox and smallpox on April 5 at 12:25 p.m. ET, while Dr. Farooq Nasar will present on the horsepox virus as a vaccine platform for SARS-CoV-2 on April 6 at 10:10 a.m. ET. Additionally, Dr. Sina Bavari will moderate a panel on mpox vaccine development challenges on April 6 at 11:30 a.m. ET. Presentation materials will be available on the company's website post-conference.
On March 23, 2023, Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) presented at the Rare Disease Innovation and Partnership Summit. The presentation focused on TNX-2900, an intranasal potentiated oxytocin being developed to treat hyperphagia in adolescents and young adults with Prader-Willi Syndrome (PWS). This formulation, enhanced with magnesium, aims to improve receptor activation for better appetite control. The FDA has granted Orphan Drug designation for TNX-2900. Currently, there are no approved treatments for hyperphagia related to PWS, making this development significant for affected patients.
On March 23, 2023, Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced that CEO Seth Lederman will present at the 5th International Congress on Controversies in Fibromyalgia. The presentation will cover the efficacy and safety of TNX-102 SL for fibromyalgia, based on results from the randomized RELIEF trial. It is scheduled for March 30, 2023, at 5:10 p.m. CEST in Vienna, Austria. Additionally, a poster presentation will accompany the oral presentation. The company’s abstract will be published in a special issue of Clinical and Experimental Rheumatology. Tonix is focused on developing novel therapeutics, with interim data for TNX-102 SL expected in Q2 2023.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced that Jessica Morris, COO, will present at the Virtual March Investor Summit on March 29, 2023, at 9:00 a.m. ET. Interested investors can arrange meetings through the conference coordinator. The presentation will be available via webcast on the Tonix website. Tonix focuses on developing therapeutics for CNS, rare diseases, immunology, and infectious diseases. Their lead candidate, TNX-102 SL, is in mid-Phase 3 for fibromyalgia, with interim data due in Q2 2023. Additionally, TNX-1300 for cocaine intoxication and TNX-801 vaccine for smallpox are among the key products in development.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) will present at the Rare Disease Innovation and Partnership Summit from March 21-23, 2023, in Philadelphia. Dr. Herbert Harris will discuss TNX-2900, an intranasal treatment aimed at managing hyperphagia in adolescents and young adults with Prader-Willi Syndrome. The presentation is scheduled for March 23, 2023, from 1:15 p.m. to 1:45 p.m. ET. TNX-2900 holds an Orphan Drug designation by the FDA, indicating its potential significance in addressing this rare condition. Tonix's broader portfolio includes various candidates addressing CNS, rare diseases, and infectious diseases.