Wall Street Zen downgraded shares of Tonix Pharmaceuticals (NASDAQ:TNXP – Free Report) from a hold rating to a sell rating in a research note issued to investors on Saturday morning,Wall Street Zen reports. A number of other research firms also recently commented on TNXP. Raymond James Financial reiterated a “strong-buy” rating and set a $27.00 […]

Wall Street Zen lowered shares of Tonix Pharmaceuticals from a "hold" rating to a "sell" rating in a research note on Saturday.

By David Bautz, PhD NASDAQ: TNXP READ THE FULL TNXP RESEARCH REPORT Business Update $11.0 Million in Net Revenue for Tonmya® in 2Q26 Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) is continuing the commercial launch of Tonmya® following its approval in August 2025 and commercial launch in November 2025. Sales metrics for the second quarter of 2026 continue to show substantial growth in prescriptions, new patients, and refills: 2Q net sales were approximately $11.0 million, which was up 194% compared to the first quarter of 2026 12,592 prescriptions, which was up 100% compared to the first quarter of 2026 A 36% increase in new patients compared to the first quarter of 2026 Refills increased 207% compared to the first quarter of 2026 The disparity between prescription growth (doubled) and revenue growth (nearly tripled) is potentially meaningful. It likely reflects a growing proportion of prescriptions converting from bridge access into reimbursed commercial prescriptions, along with refill activity among patients who have already initiated treatment. The 207% increase in refills is particularly encouraging since recurring utilization is more indicative of durable commercial demand than gross prescription volume alone. Future quarters should provide additional insight in order to distinguish between initial market uptake and a recurring patient base. Tonix continues payer engagement to increase market access. In July 2026, Tonix announced a major managed Medicare agreement for Tonmya that will add approximately nine million Medicare lives when the new agreement goes into effect on January 1, 2027. When combined with the two prior commercial coverage agreements with leading group purchasing organizations (GPOs), and Medicaid availability in most states representing approximately 73 million lives, on January 1, 2027, pharmacy coverage will total approximately 145 million individuals. The timing of the payer expansion is important. The majority of the 2Q26 revenue increase occurred while Tonix was still building commercial access, suggesting that the approximately $11.0 million quarterly revenue base does not necessarily represent the ceiling for the current launch infrastructure. Tonix expects to deploy an additional 50 sales representatives by September 2026, increasing its sales force to approximately 150 representatives. At this point, we believe the key commercial question has begun shifting from whether Tonmya can generate prescriptions to whether the company can convert those prescriptions into a large, persistent, reimbursed patient population. The large increase in refills is an early positive indicator. Refill trends, monthly prescription growth, the conversion of bridge prescriptions to reimbursed prescriptions, and the productivity of the expanded sales force will be the most important commercial metrics to monitor over the next several quarters. Update on TNX-4800 Tonix is developing TNX-4800 (formerly 2217LS), a long-acting, human monoclonal antibody (mAb) prophylactic treatment for the prevention of Lyme disease. It is being developed for annual seasonal use in the spring to protect against Lyme disease through the entire tick season in the U.S. There are currently no FDA-approved vaccines or prophylactics to protect against Lyme disease. The company recently conducted a Type C meeting with the FDA early in the third quarter of 2026, with the final meeting minutes showing agency support for an adaptive Phase 2 field study in 1Q27, subject to final FDA review and agreement on the study protocol. It will be a randomized, double blind, placebo controlled, adaptive Phase 2 field study to evaluate the efficacy of a two-dose subcutaneous regiment of TNX-4800 in preventing the first occurrence of confirmed Lyme disease during the primary efficacy surveillance period (Day 3 through Month 6 following administration). Each fixed dose is expected to provide exposures comparable to the 5 mg/kg dose evaluated in the Phase 1 trial. The first dose will be administered in the spring, and the second booster dose will be administered three months later. Eligible participants will be adults and adolescents 16 years of age and older in Lyme-endemic areas in the U.S. The primary endpoint will be the prevention of Lyme disease for six months (comparison of TNX-4800 group and placebo group) from the initial dose. A key secondary endpoint will be protection through three months. Background on TNX-4800 TNX-4800 was developed by researchers at UMass Chan Medical School. It is directed against the outer-surface protein A (OspA) expressed on Borrelia burgdorferi, the bacteria that causes Lyme disease. The OspA protein contains an epitope that mimics human leukocyte function-associated antigen 1 (LFA-1) (Steere et al., 2003). Thus, antibody treatments targeting the OspA protein need to avoid that region in order to decrease the chances for potential autoimmune cross-reactivity. LYMErix™ was an FDA-approved vaccine to prevent Lyme disease; however, it was voluntarily pulled from the market due in part due to concerns over a possible link to an arthritogenic autoimmune condition that may have been triggered by cross-reactivity to LFA-1 (Nigrovic et al., 2007). Importantly, TNX-4800 does not bind to that same epitope, but instead binds to the 71-141 region of the OspA protein, which has no human homologue. The mAb 2217LS was derived from mAb 2217 by amino acid substitutions to prolong the serum half-life. The following image shows the serum concentration of both mAb 2217 and 2217LS over a 90-day span following injection into nonhuman primates (NHPs). The antibody was tested in an NHP challenge model, in which animals were first dosed with 2217LS before multiple B. burgdorferi-infected ticks were placed on their backs for six days (Schiller et al., 2021). The study included five dosing cohorts: four different doses of 2217LS (3, 10, 30, 90 mg/kg) and a sham IgG (10 mg/kg). The results showed that of the 20 NHPs treated with 2217LS, only one became infected. An overview of the study is given below. Background on Lyme Disease Lyme disease is caused by the bacterium Borrelia burgdorferi. While it can occur all across the U.S., it is reported most often in the Northeast and Midwest. The overall prevalence of Lyme disease has been increasing over time, as shown by the following maps of reported cases from 1995 and 2023 (CDC). There are approximately 80 million individuals in the U.S. that are at risk for Lyme disease. There are a number of different signs and symptoms for Lyme disease, with the most telling being a rash, which occurs in 70-80% of people (CDC). Additional symptoms of early disease include fever, chills, headache, fatigue, muscle and joint aches, and swollen lymph nodes. Later signs of the disease include severe headaches and neck stiffness, arthritis, intermittent pain in tendons, joints, and bones, heart palpitations, and nerve pain. burgdorferi bacteria live in the mid-gut of ticks and adhere through the outer membrane protein OspA (de Silva et al., 1996). Following a tick bite, iron from the blood of the host downregulates OspA, which causes the bacteria to migrate from the midgut to the salivary glands for transmission (Radolf et al., 2012). While OspA is essential for transmission, it is expressed at very low levels in the human host once transmission has occurred; thus, the immune system does not mount an immune response or produce antibodies to OspA. Following administration of an anti-OspA mAb (e.g., TNX-4800), the circulating antibody is ingested by the tick, and it then blocks OspA on B. burgdorferi inside the tick and prevents transmission of the bacteria from the tick to the human host. Competitive Analysis Multiple monoclonal antibody preventive treatments have recently been accepted by the FDA and the market. Enflonsia™, Beyfortus®, and Pemgarda™ are monoclonal antibody prophylaxis treatments that have been approved for respiratory syncytial virus (RSV) and COVID-19. Enflonsia, Beyfortus, and Pemgarda are estimated to have 2030 revenues of $955 million, $2.9 billion, and $570 million, respectively (EvaluatePharma). Thus, we view a preventative monoclonal antibody treatment for Lyme disease as a potential blockbuster. Pfizer is developing VLA15, a vaccine for the prevention of Lyme disease. TNX-4800 has a number of advantages compared to VLA15, which are summarized in the table below. We believe the greatest advantages lie with the rapid onset of protection (~2 days compared to 6-7 months post 3 vaccinations) and only two administrations that provide protection for ≥6 months compared to three administrations needed to obtain protection with uncertain durability. HORIZON Trial in MDD Underway In June 2026, Tonix announced that the first patient was enrolled into the HORIZON trial. It is a randomized, double blind, placebo controlled Phase 2 study that is evaluating TNX-102 SL 5.6 mg as a first-line monotherapy in adults with major depressive disorder (MDD). Approximately 360 patients are expected to be enrolled across approximately 30 U.S. sites. The primary endpoint is the change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score at Week 6. Tonix has positioned this study as “potentially pivotal”, thus, instead of functioning as an exploratory proof-of-concept study, the trial is designed to generate data that could potentially support a regulatory pathway with fewer additional clinical steps if the results are sufficiently robust and the FDA agrees with the development strategy. The support for evaluating TNX-102 SL as a treatment for depression stems from results of TNX-102 SL in fibromyalgia and post-traumatic stress disorder (PTSD) clinical trials. For example, in the RESILIENT Phase 3 trial, there was a greater reduction in the total Beck Depression Inventory-II score in the TNX-102 SL cohort compared to placebo at Week 14 with an effect size of 0.27,

By David Bautz, PhD NASDAQ: TNXP READ THE FULL TNXP RESEARCH REPORT Business Update $11.0 Million in Net Revenue for Tonmya® in 2Q26 Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) is continuing the commercial launch of Tonmya® following its approval in August 2025 and commercial launch in November 2025. Sales metrics for the second quarter of 2026 continue to show substantial growth in

BERKELEY HEIGHTS, N.J., Sept. 02, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial-stage biopharmaceutical company, today announced that the management team will participate in a fireside chat and 1x1s at Cantor’s 2026 Global Healthcare Conference, being held September 9-11, 2026, in New York.

Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP - Get Free Report) CEO Seth Lederman acquired 2,000 shares of the stock in a transaction on Thursday, August 27th. The stock was bought at an average cost of $13.79 per share, with a total value of $27,580.00. Following the completion of the transaction, the chief executive officer owned 11,005 shares in the company, valued at $151,758.95. This trade represents a 22.21% increase in their ownership of the stock. The transaction was disclosed in a legal filing with the SEC, which is accessible through this hyperlink.

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Wall Street Zen upgraded shares of Tonix Pharmaceuticals from a "sell" rating to a "hold" rating in a research note on Saturday.

Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP - Get Free Report) Director Richard Bagger acquired 1,000 shares of the business's stock in a transaction dated Thursday, August 20th. The stock was acquired at an average cost of $12.60 per share, with a total value of $12,600.00. Following the purchase, the director directly owned 1,000 shares in the company, valued at $12,600. This represents a ∞ increase in their position. The transaction was disclosed in a filing with the SEC, which can be accessed through this link.

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Tonix Pharmaceuticals (NASDAQ:TNXP) is focusing its near-term strategy on the commercial launch of TONMYA for fibromyalgia while advancing development programs in Lyme disease prevention and major depressive disorder, Chief Executive Officer Seth Lederman said during a Canaccord Genuity conference p

TONMYA sales hit $11 million in its second quarter on market.

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BERKELEY HEIGHTS, N.J., Aug. 05, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial-stage biotechnology company, today announced that the management team will participate in two upcoming investor conferences in August and September 2026. Canaccord Genuity 46th Annual Growth Conference Fireside ChatPresenter: Seth Lederman, M.D., President and Chief Executive Officer of Tonix PharmaceuticalsLocation: Boston, Massa

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BERKELEY HEIGHTS, N.J., July 27, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial-stage biotechnology company, today announced that it will host a conference call and webcast to report second quarter 2026 financial results and operational highlights on Monday, August 10, 2026, at 8:30 a.m. ET. To listen to the conference call, register at this link. To view the webcast, register at this link. A replay will be a

Data show clade IIb from 2022 outbreak is 100 to 100,000-fold less virulent than clade IIa from 2003 outbreak

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Tonix Pharmaceuticals announces management participation at BTIG Infectious Disease Day 2026, with a spotlight on its growing clinical portfolio and imminent Phase 2 trials for a variety of unmet medical needs. The article delves into Tonix’s diversified development strategy and highlights their forward-looking R&D priorities.

BERKELEY HEIGHTS, N.J., June 11, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) ("Tonix" or the "Company"), a fully-integrated, commercial-stage biotechnology company, today announced that the management team will participate in 1x1 meetings at BTIG’s Infectious Disease Day 2026, held virtually on June 16, 2026.

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Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP – Get Free Report) CEO Seth Lederman purchased 5,000 shares of the business’s stock in a transaction on Tuesday, June 9th. The shares were bought at an average cost of $11.79 per share, with a total value of $58,950.00. Following the acquisition, the chief executive officer directly owned 9,005 shares […]

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Tonix announced a second commercial payer agreement for Tonmya, its fibromyalgia treatment.

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Phase 1 data support TNX-1500 as a potentially first-in-class, best-in-class, third-generation anti-CD40L monoclonal antibody for the prevention of kidney transplant rejection

By David Bautz, PhD NASDAQ: TNXP READ THE FULL TNXP RESEARCH REPORT Business Update Tonmya™ Update Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) is continuing the commercial launch of Tonmya® following its approval in November 2025. Sales metrics for the first quarter of 2026, which is the first full quarter of sales since the launch, include: 2,145 unique healthcare providers prescribed

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Tonix Pharmaceuticals is set to share data analyzing real-world fibromyalgia patients in the U.S. at ISPOR 2026, building on TONMYA’s status as the first new fibromyalgia treatment approved in over 15 years. Here’s how this presentation may impact both the company’s clinical outlook and investor interest.

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