TNXP

Tonix Pharmaceuticals Announces First Patient Enrolled in Phase 2 HORIZON Study of TNX-102 SL for the Treatment of Major Depressive Disorder (MDD)

Tonix Launches HORIZON Phase 2 MDD Trial for TNX-102 SL

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    <h3>Information</h3>
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    <h3>AI Summary</h3>
    <p>Tonix announced the first patient enrollment in HORIZON, a Phase 2 trial of TNX-102 SL 5.6 mg as a first-line MDD therapy. The 6-week MADRS-focused study expects about 360 patients across ~30 sites. If positive, the program could broaden TNX-102 SL’s use beyond fibromyalgia, leveraging sleep-improvement signals.</p>
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    <h3>Key Points</h3>
    <ul><li>First patient enrolled in HORIZON Phase 2 MDD trial for TNX-102 SL 5.6 mg.</li><li>HORIZON targets MADRS change at Week 6 in ~360 patients across ~30 US sites.</li><li>TNX-102 SL previously studied for sleep improvement and fibromyalgia; TONMYA launched in 2025.</li><li>Patent protections extend U.S. market exclusivity to 2034; method-of-use patents possible to 2044.</li><li>Tonix aims to expand TNX-102 SL into MDD and other sleep-related indications.</li></ul>
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  <section data-block="companies-mentioned">
    <h3>Companies Mentioned</h3>
    <ul><li><strong>Tonix Pharmaceuticals Holding Corp. (TNXP)</strong>: Announced first-patient enrollment in HORIZON Phase 2 MDD trial; potential MDD expansion for TNX-102 SL.</li><li><strong>TNX-102 SL (drug candidate) (TNX-102 SL)</strong>: Core asset in Tonix pipeline; Phase 2 MDD readouts could unlock value.</li><li><strong>TONMYA (Tonix product) (TONMYA)</strong>: FDA-approved fibromyalgia treatment; provides near-term revenue base.</li></ul>
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    <h3>Corporate Developments</h3>
    <p>Category fits Corporate Developments, highlighting pipeline progress and potential strategic value from expanded indications.</p>
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    <h3>Market-Moving</h3>
    <ul><li>First-patient enrollment in HORIZON may trigger near-term volatility.</li><li>Phase 2 readout cadence and endpoint focus on MADRS drive milestone-driven moves.</li><li>Tonix’s TONMYA revenue base provides optionality to upside for TNX-102 SL.</li></ul>
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  <section data-block="key-facts">
    <h3>Key Facts</h3>
    <ul><li>HORIZON is a 6-week Phase 2 study.</li><li>TNX-102 SL 5.6 mg is a bedtime monotherapy.</li><li>~360 patients across ~30 US sites.</li><li>First patient enrolled on June 29, 2026.</li><li>FDA-approved TONMYA for fibromyalgia in August 2025.</li><li>US exclusivity through 2034; method-of-use patents potentially through 2044.</li></ul>
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    <h3>Trading Thesis</h3>
    <p>If HORIZON yields favorable MADRS signals, TNXP could trend higher on MDD optimism within 12–24 months.</p>
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    <h2>Tonix Pharmaceuticals Announces First Patient Enrolled in Phase 2 HORIZON Study of TNX-102 SL for Major Depressive Disorder (MDD)</h2>
    <p>Tonix Pharmaceuticals Holding Corp. (TNXP) today announced that the first patient has been enrolled in HORIZON, a potentially pivotal Phase 2 study evaluating TNX-102 SL 5.6 mg as a first-line monotherapy in adults with major depressive disorder (MDD). The study is a <strong>6-week</strong>, randomized, double-blind, placebo-controlled trial designed to measure the change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6. TNX-102-SL was approved by the U.S. Food and Drug Administration (FDA) in August 2025 and launched commercially as TONMYA<sup>&#xAE;</sup> for the treatment of fibromyalgia in adults.</p>
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    <p>“We are committed to extending the science of TNX-102 SL into other conditions in which disturbed sleep quality plays important roles, including MDD,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “TNX-102 SL for MDD is designed to target poor sleep quality. Bedtime TNX-102 SL showed signals for improving depressive symptoms and subjective sleep quality in both a prior Phase 2 posttraumatic stress disorder study and two Phase 3 fibromyalgia studies. We look forward to evaluating TNX-102 SL in the Phase 2 HORIZON trial to learn if these promising signals will translate into benefits in MDD.”</p>
    <p>Dr. Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals added, “More than 21 million U.S. adults<sup>1</sup> experience a major depressive episode each year, and many current therapies are associated with tolerability and adherence challenges. TNX-102 SL for MDD is designed to target disturbed sleep through potent antagonism at four neuronal receptors that influence sleep quality. The quality of sleep, particularly deep slow wave sleep, is a critical factor in the nightly homeostatic neuro-restoration critical for recovery from stress-associated conditions such as MDD.”</p>
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  <section id="study-details">
    <p>HORIZON is a <strong>6-week</strong>, randomized, double-blind, placebo-controlled Phase 2 study evaluating TNX-102 SL 5.6 mg as a first-line monotherapy in adults with MDD. Approximately <strong>360</strong> patients are expected to enroll at approximately <strong>30</strong> sites across the United States. Eligible participants are 18 years of age or older and currently experiencing a moderate to severe major depressive episode. Participants will receive TNX-102 SL 5.6 mg taken sublingually at bedtime or matching placebo. The primary endpoint of the study is the change from baseline in MADRS total score at Week 6. Secondary endpoints include global impression scores, anxiety ratings, and measures of sleep quality and disturbance.</p>
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  <section id="about-mdd">
    <h3>About Major Depressive Disorder (MDD)</h3>
    <p>MDD is a prevalent and serious psychiatric illness that affects adults of all ages, races, and backgrounds. It is characterized by persistent feelings of sadness or loss of interest, along with symptoms such as sleep and appetite disturbances, fatigue, difficulty concentrating, and thoughts of worthlessness or suicide. These symptoms must last at least two weeks and significantly impair daily functioning. In the United States, more than 21 million adults experience a major depressive episode each year. While several antidepressant medications are available, many individuals do not achieve adequate relief or discontinue treatment due to side effects such as weight gain, sleep disruption, cognitive impairment, and sexual dysfunction. MDD is associated with an increased risk of suicide and substantial impairment in quality of life, underscoring the urgent need for new, first-line therapies that are demonstrated to be both effective and well tolerated.</p>
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  <section id="about-tnx102-sl">
    <h3>About TNX-102 SL</h3>
    <p>TNX-102 SL is a novel sublingual tablet formulation of cyclobenzaprine hydrochloride that enables rapid transmucosal absorption and reduces production of the persistent active metabolite, norcyclobenzaprine, by bypassing first-pass hepatic metabolism. TNX-102 SL is a tertiary amine tricyclic (TAT) and multifunctional agent with potent binding and antagonist activities at the 5-HT<sub>2A</sub> serotonergic, α<sub>1</sub>-adrenergic, H<sub>1</sub>-histaminergic, and M<sub>1</sub>-muscarinic receptors. It is currently FDA approved in the U.S. as a once-daily bedtime treatment for fibromyalgia in adults under the brand name TONMYA<sup>&#xAE;</sup> (cyclobenzaprine HCl sublingual tablets). TNX-102 SL is also in development as a daily bedtime treatment for acute stress disorder (ASD)/acute stress reaction (ASR) under an investigator-initiated IND. In addition to MDD, Tonix also holds active INDs for the following indications for TNX-102 SL: Long COVID (post-acute sequelae of COVID-19), PTSD, alcohol use disorder, and agitation in Alzheimer’s disease. The United States Patent and Trademark Office issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10357465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patents are important elements of Tonix’s proprietary composition. These patents are expected to provide TNX-102 SL U.S. market exclusivity until 2034. Pending patent applications related to method of use could extend exclusivity until 2044. The potential use of TNX-102 SL in MDD, ASD/ASR, and other unapproved indications is currently under clinical development, and the safety and efficacy have not been evaluated by any regulatory authority.</p>
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  <section id="references">
    <p><strong>Citations</strong><br/><sup>1</sup> Substance Abuse and Mental Health Services Administration (SAMHSA). 2024. Key Substance Use and Mental Health Indicators in the United States: Results from the 2024 National Survey on Drug Use and Health.</p>
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  <section id="about-company">
    <h3>About Tonix Pharmaceuticals Holding Corp.</h3>
    <p>Tonix Pharmaceuticals is a fully integrated, commercial-stage biotechnology company focused on central nervous system (CNS) disorders, infectious diseases, immunology conditions, and rare diseases where there exists high unmet medical need. TONMYA<sup>&#xAE;</sup> (cyclobenzaprine HCl sublingual tablets 2.8 mg), the Company’s flagship internally conceived and developed medicine, is the first new treatment for fibromyalgia in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace SymTouch (sumatriptan injection 3 mg) and Tosymra (sumatriptan nasal spray 10 mg). Tonix is extending the science behind TONMYA in Phase 2 clinical studies to evaluate its potential in major depressive disorder and acute stress disorder/acute stress reaction. Tonix is also advancing a pipeline of infectious disease programs, including monoclonal antibody TNX-4800 (anti-OspA mAb) for Lyme disease prevention in the U.S. and TNX-801 (horsepox, live virus vaccine), a vaccine in development for the prevention of mpox and smallpox. Within immunology, Tonix is developing TNX-1500 (anti-CD40L mAb), a third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. Finally, the Company’s rare disease portfolio includes TNX-2900, which is Phase 2 ready for the treatment of Prader-Willi syndrome. </p>
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Tonix announced the first patient enrollment in HORIZON, a Phase 2 trial of TNX-102 SL 5.6 mg as a first-line MDD therapy. The 6-week MADRS-focused study expects about 360 patients across ~30 sites. If positive, the program could broaden TNX-102 SL’s use beyond fibromyalgia, leveraging sleep-improvement signals.

Tonix Pharmaceuticals Announces First Patient Enrolled in Phase 2 HORIZON Study of TNX-102 SL for the Treatment of Major Depressive Disorder (MDD)

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