$13.590
+0.030 (+0.22%)Al cierre
Noticias de TNXP
Eventos de TNXP
Tonix Pharmaceuticals Q2 Revenue $13.54M, Exceeds Expectations
Reports Q2 revenue $13.54M, consensus $7.72M. "We are pleased with the execution of TONMYA's launch, including nearly tripling net sales and achieving growth across our key metrics in the second quarter," said Seth Lederman, President and Chief Executive Officer of Tonix Pharmaceuticals. "We are seeing TONMYA's value resonate among healthcare providers and patients as the first FDA-approved treatment for fibromyalgia in 15 years. It is a first-in-class, non-opioid analgesic designed for daily bedtime administration and long-term use. We are now beginning to see coverage translate into broader patient access following the execution of agreements with commercial payers, managed Medicare, and Medicaid. Our newly expanded sales force is expected to deploy in the field by September. We believe we are well positioned to reach more of our target prescribers and support the treatment of more patients with TONMYA."
Tonix Pharmaceuticals Receives FDA Meeting Minutes for TNX-4800 Adaptive Phase 2 Study
Tonix Pharmaceuticals announced the receipt of official minutes from the Type C meeting with the FDA to discuss the company's plans for an adaptive Phase 2 field study of TNX-4800 to prevent Lyme disease in adults in the U.S. OspA on immature Borrelia bacteria in the midgut of infected deer ticks is a validated target for Lyme disease prevention previously targeted by vaccines.1-3 TNX-4800 is a potential seasonal immunopreventative alternative to vaccination and is Fc-modified for extended half-life and duration of protection. Participants in the planned adaptive Phase 2 field study will be randomized 1:1 to receive either TNX-4800 450 mg SC or a placebo, and another dose of TNX-4800 or placebo approximately three months later. The company plans to enroll adult volunteers aged 18 and older who live in Lyme-endemic areas in the U.S. and engage in activities that increase their risk of deer tick bites.
Tonix Pharmaceuticals Announces Medicare Agreement Covering 9 Million Lives
Tonix Pharmaceuticals announced a managed Medicare agreement for Tonmya, adding approximately 9M Medicare lives. The new agreement will go into effect on January 1, 2027. On top of two prior commercial coverage agreements with leading group purchasing organizations effective in the second quarter of 2026, and Medicaid availability in most states representing approximately 73M lives, pharmacy coverage for Tonmya on January 1, 2027, will total approximately 145M covered lives. Discussions with other commercial and Medicare payers continue to advance.
Tonix Pharmaceuticals Enrolls First Patient in HORIZON Study
Tonix Pharmaceuticals 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.
Tonix Pharmaceuticals Publishes TNX-1500 Clinical Study Results
Tonix Pharmaceuticals announced the publication of a paper, "First-in-Human, Phase 1, Randomized, Double-Blind, Placebo-Controlled Study of TNX-1500, an Fc-Modified anti-CD154 Monoclonal Antibody, Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-Ascending Doses in Healthy Adults," in the peer-reviewed Journal of Clinical Immunology. TNX-1500 is an investigational, third-generation Fc-modified IgG4 anti-CD40L monoclonal antibody in development for the prevention of organ transplant rejection and the treatment of autoimmune diseases. The publication reports findings from a single-center, first-in-human, Phase 1, randomized, double-blind, placebo-controlled, single-ascending dose escalation study in 26 healthy adult volunteers. Participants were enrolled across three ascending dose cohorts or placebo and received a single intravenous infusion of TNX-1500 or placebo, followed by intramuscular injections of KLH on days 2 and 29 to assess the TDAR, and monitored over a 120-day follow-up period. TNX-1500 blocked the primary T cell-dependent antibody response to KLH at all doses, blocked the secondary response at the 10 and 30 mg/kg doses, and reduced peak secondary response to KLH by ~70% relative to placebo at the 3 mg/kg dose. TNX-1500 was generally well tolerated, with no serious adverse events, and no discontinuations due to adverse events. The only treatment-emergent adverse event deemed possibly related to study drug was aphthous ulcer, which occurred in 1 participant in each of the three TNX-1500 groups; all TEAEs were rated as mild and resolved in 2-10 days. No TEAEs were determined to be related to KLH administration. There were no administration or injection site reactions. Pharmacokinetic analyses suggested approximately dose-proportional exposure across the 3 to 30 mg/kg range, with mean terminal elimination half-lives of 37.8 and 33.8 days at the 10 and 30 mg/kg dose levels, respectively. TNX-1500 at 10 and 30 mg/kg blocked the primary and secondary anti-KLH TDAR through day 120, and at 3 mg/kg reduced the peak secondary response by approximately 70% relative to placebo. Across all dose cohorts, TNX-1500 was associated with a rapid and sustained reduction in soluble CD40L over the 120-day study period.
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