Tonix Pharmaceut Stock Price, News & Analysis

Tonix Pharmaceuticals (Nasdaq: TNXP) presented Phase 3 RESILIENT data showing statistically significant pain reduction (p<0.0001) with Tonmya (cyclobenzaprine HCl sublingual tablets) versus placebo in adults with fibromyalgia.

The 14-week, randomized, double-blind trial enrolled 456 intent-to-treat participants across 34 U.S. sites. Tonmya also produced meaningful improvements in sleep, fatigue, and fibromyalgia symptoms/function, and exploratory analyses showed sexual function gains in female participants.

Tonmya was FDA approved on August 15, 2025. Safety findings included low adverse event–related discontinuations (6.1% on Tonmya vs 3.5% placebo) and mostly mild oral mucosal reactions; labeled risks include embryofetal toxicity and serotonin syndrome drug interactions.

Tonix Pharmaceuticals (Nasdaq: TNXP) announced the first patient has been dosed in the investigator‑initiated FOCUS study at Massachusetts General Hospital on Oct 22, 2025. The randomized, double‑blind, placebo‑controlled crossover pilot will evaluate Tonix's intranasal potentiated oxytocin products TNX-2900 (6 IU) and TNX-1900 (24 IU) in adults with arginine‑vasopressin deficiency (AVP‑D), a rare endocrine disorder formerly called central diabetes insipidus.

The study will measure single‑dose effects on anxiety, depression, and socioemotional functioning and include an exploratory two‑week replacement analysis to generate preliminary data to inform future clinical studies.

Tonix Pharmaceuticals (Nasdaq: TNXP) announced a poster presentation on Tonmya (cyclobenzaprine HCl sublingual tablets) at the 2025 American College of Rheumatology Convergence on October 27, 2025, presented by Dr. Gregory Sullivan.

The poster title reports that TNX-102 SL/Tonmya demonstrated pain reduction and favorable tolerability in participants with fibromyalgia. Tonix notes Tonmya is FDA-approved for fibromyalgia and that the company will post the presentation under the Presentations tab at https://ir.tonixpharma.com/presentations.

Tonix Pharmaceuticals (Nasdaq: TNXP) presented preclinical data for its investigational live, attenuated vaccine candidate TNX-801 at World Vaccine Congress–Europe 2025 (Oct 14–16, 2025).

Presentations reported that a single dose of TNX-801 produced durable immunogenicity for at least 14 months, elicited strong neutralizing antibodies, and protected non-human primate, rabbit, and murine models from clinical disease and mortality after mpox challenge. TNX-801 was described as well tolerated across percutaneous, subcutaneous, and intramuscular routes. The company said the data support advancing TNX-801 toward clinical development and noted interest in evaluating a microneedle patch delivery option.

Tonix Pharmaceuticals (Nasdaq: TNXP) announced that CEO Seth Lederman, M.D. presented on Oct 9–11, 2025 at the 61st Annual Congress of the Japan Society for Transplantation in Nagoya.

The presentation reviewed the history of anti-CD154/CD40L immunomodulation and featured Phase 1 safety and pharmacodynamic/biomarker data for TNX-1500, Tonix’s third-generation Fc-modified dimeric anti-CD40L monoclonal antibody. The company said these data support continued development toward Phase 2 for prevention of kidney transplant rejection and treatment of autoimmune diseases. A copy of the presentation is available on Tonix’s investor presentations page.

The talk noted TNX-1500’s design to reduce thromboembolic risk and referenced renewed interest in regulatory T cells after the 2025 Nobel Prize for T reg discovery.

Tonix Pharmaceuticals (Nasdaq: TNXP) announced company executives will present and join a panel at the World Vaccine Congress–Europe 2025 in Amsterdam on October 14–16, 2025.

Dr. Sina Bavari will present on Safety, Durability and Protection of a Single-Dose TNX-801 Mpox Vaccine on October 15, 2025 at 2:15 p.m. CEST. Dr. Bavari and Dr. Zeil Rosenberg will join a panel titled Can We Enhance Vaccine Effectiveness? Mpox (Monkeypox) as a Model on October 14, 2025 at 11:30 a.m. CEST.

A copy of the presentation will be posted under the Presentations tab at the company's investor website following the conference. The release also summarizes Tonix's marketed product Tonmya and its infectious disease pipeline including TNX-801 and related programs.

Tonix Pharmaceuticals (Nasdaq: TNXP) has appointed Ganesh Kamath as Head of Market Access, effective September 29, 2025. This appointment strengthens the company's commercial leadership team ahead of the Q4 2025 launch of Tonmya™, their recently FDA-approved treatment for fibromyalgia in adults.

Kamath brings over 25 years of experience in market access, pricing, and commercial operations from positions at Bayer HealthCare, Hutchmed International, and CuriaGlobal. The appointment follows the FDA approval of Tonmya on August 15, 2025, marking the first new fibromyalgia therapy approval in more than 15 years.

Tonix's portfolio includes marketed migraine treatments and development candidates across CNS disorders, immunology, rare diseases, and infectious diseases, including a $34 million DoD contract for TNX-4200 development.

Tonix Pharmaceuticals (NASDAQ:TNXP) has announced plans to initiate a Phase 2 clinical trial for TNX-2900, its intranasal potentiated oxytocin treatment for Prader-Willi Syndrome (PWS), in 2026. The trial will evaluate the drug in children and adolescents aged 8-17.5 years.

TNX-2900 has received both Orphan Drug and Rare Pediatric Disease designations from the FDA, making it eligible for a Priority Review Voucher upon approval. The drug features a magnesium-potentiated formulation designed to improve receptor binding and reduce dose-related inconsistencies. The Phase 2 study will be randomized, double-blind, and placebo-controlled, with participants receiving either TNX-2900 at three different dose levels or placebo for 12 weeks.

PWS affects 1 in 10,000 to 1 in 30,000 births and is the leading cause of life-threatening childhood obesity. The trial's primary endpoint will measure changes in hyperphagia severity using the HQ-CT questionnaire, with secondary objectives assessing behavior, caregiver burden, and quality of life measures.

Tonix Pharmaceuticals (NASDAQ:TNXP) announced successful completion of a Pre-IND meeting with the FDA regarding TNX-102 SL for treating major depressive disorder (MDD). The company plans to file an IND application in Q4 2025 and pursue a supplemental new drug application (sNDA) to expand TNX-102 SL's indication to include MDD.

TNX-102 SL, already FDA-approved for fibromyalgia under the brand name Tonmya™, showed promising results in improving depression symptoms during the Phase 3 RESILIENT study. The drug's unique formulation allows for transmucosal absorption, bypassing first-pass hepatic metabolism, and requires significantly lower doses compared to traditional tricyclic antidepressants.