Tonix Pharmaceuticals Holding Corp. - TNXP STOCK NEWS

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.

Tonix Pharmaceuticals (Nasdaq: TNXP) has initiated the Phase 2 UPLIFT study for TNX-601 ER, an extended-release formulation of tianeptine, targeting major depressive disorder (MDD). With a planned enrollment of 300 participants across 30 U.S. sites, the study aims to analyze safety and efficacy, with interim results anticipated in Q4 2023. TNX-601 ER is designed to enhance neuroplasticity, presenting a novel approach to MDD treatment compared to traditional antidepressants. Tianeptine has been used internationally for over 30 years and offers a potentially improved safety profile with minimal side effects.

Tonix Pharmaceuticals (Nasdaq: TNXP) announced its financial results for Q4 and the full year 2022, reporting a net loss of $116.9 million for the year, equating to a loss of $3.27 per share. As of December 31, 2022, the company had approximately $120.2 million in cash and cash equivalents. The company is currently conducting an interim analysis of its Phase 3 fibromyalgia trial, with topline data expected in Q4 2023. Additionally, two potentially pivotal Phase 2 trials are set for interim analyses in the same quarter for TNX-1900 in chronic migraine and TNX-601 ER in depression. This expansion is aimed at addressing significant unmet medical needs.