Podcasts about tonix pharmaceuticals

Tonix Pharmaceuticals is making waves in the healthcare industry with the launch of TONIX ONE™ a fully integrated digital platform designed to empower migraine patients with better tools for understanding and managing their condition. In an exclusive discussion with Proactive's Steve Darling, Dr. Seth Lederman, CEO of Tonix Pharmaceuticals, unveiled the platform's innovative features and strategic partnerships aimed at transforming migraine care. By collaborating with UpScript Telemedicine, ProModRx, Blink Health, and a leading mobile application specializing in disease tracking, symptom reporting, and management, TONIX ONE offers a comprehensive, patient-centric solution. Dr. Lederman highlighted that TONIX ONE™ beyond conventional migraine education by providing critical insights into the limitations of oral medications, which can sometimes result in delayed or ineffective symptom relief. The platform bridges the gap between patients and healthcare providers, offering direct access to migraine specialists via telehealth consultations and seamless e-prescription requests—ensuring a faster, more effective pathway to treatment. With this initiative, Tonix Pharmaceuticals aims to not only educate and empower patients in their treatment journey but also eliminate the barriers to care that many migraine sufferers face. By integrating advanced digital health solutions,TONIX ONE™ stands at the forefront of a new era in migraine management, offering patients greater control over their health and well-being. #proactiveinvestors #tonixpharmaceuticalsholdingcorp #nasdaq #tnxp #Biotech #MigraineTreatment #TonixOne #DigitalHealth #Telemedicine #ZembraceSymTouch #Tosymra #HealthcareInnovation #PharmaNews #ProactiveInvestors

Tonix Pharmaceuticals CEO Dr. Seth Lederman joined Steve Darling from Proactive to announce that the company has been awarded a grant from the Medical CBRN Defense Consortium to support the continued development of its next-generation vaccine candidate. MCDC is a consortium comprising industrial, academic, and non-profit organizations that assist the U.S. government in advancing medical solutions to protect against chemical, biological, radiological, and nuclear threats. Dr. Lederman explained that the vaccine candidate is being developed as an improved immunization option for mpox and smallpox, with the potential for delivery via innovative alternative methods designed to enhance patient compliance, ease of administration, and overall tolerability. The MCDC grant will support comprehensive market analyses, target market identification, and commercialization planning for both private and government sectors. The investigational vaccine is a minimally replicating live-virus formulation based on a modified orthopoxvirus. It has demonstrated the ability to provide single-dose immune protection against mpox in preclinical studies while offering improved tolerability compared to traditional live-virus vaccines. Previous studies have also shown its effectiveness in protecting animals from lethal intratracheal exposure to a more virulent strain of the mpox virus. Tonix is currently preparing for Phase 1 clinical trials in both the United States and Kenya. Kenya, which is on the outskirts of an MPOX outbreak in Africa, presents an opportunity to test the vaccine in an area with a growing case burden. #proactiveinvestors #tonixpharmaceuticalsholdingcorp #nasdaq #tnxp #Biotech #MPOXVaccine #Smallpox #TNX801 #VaccineDevelopment #ClinicalTrials #PharmaceuticalNews #MedicalResearch #WHO #GlobalHealth #InfectiousDiseases #Biopharma #ProactiveInvestors

Tonix Pharmaceuticals CEO Dr. Seth Lederman joined Steve Darling from Proactive to discuss promising topline results from the company's Phase 1, single ascending dose trial of TNX-1500 in healthy participants. The trial evaluated safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous TNX-1500 and was designed to support dosing for an upcoming Phase 2 trial in kidney transplant recipients. Two published studies in the American Journal of Transplantation demonstrated that TNX-1500 can prevent rejection, prolong survival, and preserve graft function in non-human primate renal and heart allografts, either as a single agent or in combination with other therapies. Dr. Lederman shared that Phase 1 results showed TNX-1500 at 10 mg/kg and 30 mg/kg doses effectively blocked both primary and secondary antibody responses to a test antigen. Pharmacokinetic data suggest that monthly dosing at 10 mg/kg or higher could be effective. These findings reinforce the company's confidence in TNX-1500's potential to prevent organ transplant rejection and improve graft survival with a lower long-term toxicity burden compared to existing immunosuppressive therapies. Tonix plans to present these results to the U.S. Food and Drug Administration (FDA) in an End-of-Phase 1 meeting. Pending FDA alignment, the company will move forward with a Phase 2 efficacy study in kidney transplant recipients. #proactiveinvestors #tonixpharmaceuticalsholdingcorp #nasdaq #tnxp #TonixPharmaceuticals #Biotech #FDA #FDAApproval #TNX1500 #MonoclonalAntibodies #OrganTransplant #AutoimmuneDisease #MedicalResearch #PharmaNews #HealthcareInnovation

Tonix Pharmaceuticals CEO Dr. Seth Lederman joined Steve Darling from Proactive to announce an important milestone for the company's New Drug Application (NDA) for a novel fibromyalgia treatment. The U.S. Food and Drug Administration (FDA) has set a Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025, marking the anticipated timeline for a decision on marketing approval. The treatment is a non-opioid, centrally acting therapy designed to address fibromyalgia, a chronic and debilitating pain condition that disproportionately affects women and impacts over 10 million adults in the United States. Highlighting the significance of the FDA collaboration, Dr. Lederman stated, “We believe this therapy has the potential to become the first in a new class of medicines for managing fibromyalgia.” Data from pivotal Phase 3 trials demonstrated meaningful pain reduction with a favorable safety profile, addressing an urgent unmet need in the fibromyalgia patient community. The NDA submission is supported by data from two 14-week, double-blind, randomized, placebo-controlled Phase 3 clinical trials, which confirmed the treatment's efficacy and tolerability with no new safety concerns. Previously granted Fast Track designation by the FDA in July 2024, the therapy is recognized for its potential to transform the fibromyalgia treatment landscape. If approved, this innovative therapy would be the first new drug for fibromyalgia in more than 15 years, offering hope to millions of patients seeking effective and tolerable treatment options. #proactiveinvestors #tonixpharmaceuticalsholdingcorp #nasdaq #tnxp #FibromyalgiaTreatment #FDAApproval #TNX102SL #NonOpiateTherapy #PharmaNews #DrugDevelopment #ProactiveInvestors#invest #investing #investment #investor #stockmarket #stocks #stock #stockmarketnews

Dr. Seth Lederman, CEO of Tonix Pharmaceuticals, joined Steve Darling from Proactive to unveil promising results at the ACR Convergence 2024 Annual Meeting from the company's Phase 3 RESILIENT trial of its proprietary sublingual bedtime medication for fibromyalgia. The trial met its primary endpoint, achieving a statistically significant reduction in daily pain compared to a placebo. Additionally, the treatment demonstrated comprehensive benefits, achieving statistical significance across six key secondary measures: improved sleep quality, reduced fatigue, enhanced physical function, better overall symptoms, and increased patient satisfaction. The medication, which was generally well-tolerated with no new safety concerns, represents a potential breakthrough for fibromyalgia patients. Tonix submitted a New Drug Application (NDA) to the FDA in October 2024, with an anticipated decision in 2025. If approved, this would mark the first new fibromyalgia treatment in over 15 years, offering a novel approach by addressing sleep disturbances. Dr. Lederman also highlighted other recent milestones, including Fast Track designation from the FDA and a $34 million Department of Defense contract for antiviral research. With $28 million in cash reserves reported at the close of Q3, Tonix Pharmaceuticals is well-positioned for continued innovation and growth. #proactiveinvestors #tonixpharmaceuticalsholdingcorp #nasdaq #tnxp #FibromyalgiaTreatment #FDAApproval #PharmaNews #DrugDevelopment #SethLederman #PharmaceuticalInnovation #MedicalBreakthrough #FastTrackDesignation #invest #investing #investment #investor #stockmarket #stocks #stock #stockmarketnews

Dr. Seth Lederman, CEO of Tonix Pharmaceuticals joined Steve Darling from Proactive to share news about the company's submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration for its drug TNX-102 SL, a non-opioid analgesic designed to treat chronic pain associated with fibromyalgia. TNX-102 SL demonstrated statistically significant pain reduction in two Phase 3 studies and was well tolerated by patients. Dr. Lederman highlighted that the drug was granted Fast Track designation by the FDA in July 2024, a process aimed at speeding up the review of new treatments for serious conditions that address unmet medical needs. If approved, TNX-102 SL would be the first new class of fibromyalgia medication in over 15 years, offering hope to a large patient population that has struggled with limited treatment options. The drug, designed to be taken at bedtime on a daily basis, targets the non-restorative sleep characteristic of fibromyalgia, which Tonix believes is key to alleviating the condition's widespread pain. The company has also announced it has received its first payment from the Defense Threat Reduction Agency within the U.S. Department of Defense, to develop small molecule broad-spectrum antiviral agents for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. The previously announced award is for up to 34 million dollars over five years. #proactiveinvestors #tonixpharmaceuticalsholdingcorp #nasdaq #tnxp #FibromyalgiaTreatment #SethLederman #NDA #FDAApproval #DrugDevelopment #BiotechNews #TNX102SL #AntiviralDrugs #PharmaNews #DODContract #ClinicalTrials #invest #investing #investment #investor #stockmarket #stocks #stock #stockmarketnews

Dr. Seth Lederman, CEO of Tonix Pharmaceuticals, recently shared key findings with Steve Darling from Proactive following the company's presentations at the 11th Global Conference on Pharmaceutics and Novel Drug Delivery Systems in Rome. The presentations detailed the eutectic formation of cyclobenzaprine HCl and mannitol, highlighting its stability and rapid dissolution, allowing for efficient transmucosal delivery of cyclobenzaprine into the bloodstream. This innovative formulation protects the drug from interacting with the basifying agent needed for absorption, offering a more effective delivery system. Dr. Lederman emphasized the ongoing unmet need for fibromyalgia treatments, with many patients unsatisfied with current options. Tonix's lead candidate, TNX-102 SL, has shown significant potential as a once-daily bedtime treatment that could provide broad-spectrum symptom relief for fibromyalgia patients. With promising results from two Phase 3 studies, TNX-102 SL is positioned to become the first new treatment for fibromyalgia in 15 years, offering hope to millions of patients seeking better management of their symptoms. #proactiveinvestors #tonixpharmaceuticalsholdingcorp #nasdaq #tnxp #Fibromyalgia #TNX102SL #FDAApproval #DrugDevelopment #PharmaceuticalInnovation #BiotechNews #ClinicalTrials #invest #investing #investment #investor #stockmarket #stocks #stock #stockmarketnews

Dr. Seth Lederman, CEO of Tonix Pharmaceuticals, recently joined Steve Darling from Proactive to discuss the company's collaboration with Bilthoven Biologicals (BBio) to advance TNX-801, Tonix's promising vaccine candidate for mpox. TNX-801 is a live, replicating, attenuated virus vaccine based on horsepox, currently in preclinical development to prevent both mpox and smallpox. TNX-801 leverages cutting-edge technology with the potential to serve as a viral vector platform, enabling the development of recombinant versions to protect against other infectious diseases. BBio, a global leader in vaccine production, was selected by the European Union for its pandemic preparedness program, making them an ideal partner for this collaboration. Dr. Lederman shared that TNX-801 has shown remarkable results in preclinical studies, demonstrating immune protection in animal models with better tolerability compared to vaccines based on 20th-century vaccinia viruses. Specifically, TNX-801 has been shown to protect non-human primates against a lethal challenge with intratracheal Clade 1 monkeypox virus. Following a single-dose vaccination, the vaccine not only prevented clinical disease and lesions but also significantly decreased viral shedding in the mouth and lungs, suggesting strong mucosal immunity and the potential to block forward transmission. This collaboration between Tonix Pharmaceuticals and BBio represents a significant step forward in the fight against mpox and smallpox, and the technology behind TNX-801 may pave the way for future vaccines against a range of infectious diseases. #proactiveinvestors #tonixpharmaceuticalsholdingcorp #nasdaq #tnxp #invest #investing #investment #investor #stockmarket #stocks #stock #stockmarketnews

Tonix Pharmaceuticals CEO Seth Lederman speaks with with Proactive's Stephen Gunnion about the company's accelerated efforts to develop a single-dose vaccine for Mpox, TNX-801, in light of the World Health Organization's declaration of a global health emergency. Lederman highlighted the vaccine's promising results in animal studies, which showed protection against lethal challenges with Clade 1 Mpox virus and prevention of skin lesions, potentially blocking forward transmission. As the threat of more lethal strains like Clade 1 emerges, Tonix is ramping up its development process, focusing on producing GMP material suitable for human trials. The vaccine, based on Tonix's RPV platform, is designed for rapid distribution and could play a critical role in managing the public health crisis. Lederman also discussed the potential risks associated with Clade 1's spread beyond Africa, stressing the need for quick and effective solutions. With a single dose, this vaccine could provide a durable defense against Mpox, akin to vaccines for smallpox. The company's efforts reflect the urgency of the situation and the importance of innovative solutions in pandemic preparedness. Visit Proactive's YouTube channel for more videos, and don't forget to give this video a like, subscribe to the channel, and enable notifications for future content. #TonixPharmaceuticals #MpoxVaccine #SethLederman #TNX801 #PublicHealth #WHO #Monkeypox #Biotech #Pharmaceuticals #PandemicPreparedness#ProactiveInvestors #InvestmentStrategy #ProactiveInvestors ##invest #investing #investment #investor #stockmarket #stocks #stock #stockmarketnews

Tonix Pharmaceuticals CEO Seth Lederman joins Proactive's Stephen Gunnion after the company received FDA Fast Track designation for its drug candidate, TNX-102, aimed at managing fibromyalgia. Lederman expressed delight at the FDA's recognition of TNX-102, highlighting that this designation will expedite interactions with the FDA as they seek marketing approval, expected in 2025. He explained that fibromyalgia is a serious chronic pain condition affecting mostly women, with about 10 million patients in the United States alone. Discussing the market opportunity, Lederman mentioned that over 2 million people are currently diagnosed and treated for fibromyalgia, indicating a significant market potential. TNX 102 stands out in the market due to its impact on pain, sleep, and fatigue, with fewer side effects compared to existing treatments. Recent trials showed statistically significant improvements in these areas, positioning TNX 102 as a promising treatment. Tonix Pharmaceuticals is preparing a new drug application, aiming for a submission in the second half of 2024 and anticipating FDA approval in 2025. The Fast Track designation may also lead to a priority review, potentially reducing the review time to six months. For more updates and detailed insights, visit Proactive's YouTube channel, give the video a like, subscribe to the channel, and enable notifications for future content. #TonixPharmaceuticals #FibromyalgiaTreatment #TNX-102 #FDAFastTrack #ChronicPain #PharmaNews #MedicalResearch #DrugApproval #HealthcareInnovation #ProactiveInterviews #ProactiveInvestors #invest #investing #investment #investor #stockmarket #stocks #stock #stockmarketnews

Dr. Seth Lederman, CEO of Tonix Pharmaceuticals, recently joined Steve Darling from Proactive to discuss the implications of a groundbreaking report from the US National Academies of Sciences, Engineering, and Medicine on long Covid. The report defines long Covid as a chronic condition encompassing multiple diagnosable disorders, thus paving the way for better understanding and treatment approaches. A particularly significant finding in the report is the acknowledgment that fibromyalgia can now be diagnosed in patients with long Covid, which eliminates previous diagnostic uncertainties. This development is especially beneficial for Tonix Pharmaceuticals, as the company is advancing TNX-102 SL, a drug designed to treat fibromyalgia. Dr. Lederman pointed out that this new diagnostic clarity could substantially broaden the addressable market for TNX-102 SL, which already targets approximately 10 million American adults diagnosed with fibromyalgia. Tonix Pharmaceuticals is in the final stages of developing TNX-102 SL, having received FDA Fast Track designation in recognition of its significant potential. The company has completed two statistically significant studies and is preparing a new drug application for submission. Dr. Lederman, who has nearly 30 years of experience researching fibromyalgia, emphasized the potential impact of this report on the estimated 14 million Americans suffering from long Covid. This new diagnostic criterion could enable these individuals to access effective treatments for fibromyalgia, representing a significant advancement in patient care. #proactiveinvestors #tonixpharmaceuticalsholdingcorp #nasdaq #tnxp #TonixPharmaceuticals, #SethLederman, #LongCovid, #Fibromyalgia, #NationalAcademies, #USScience, #TNX102SL, #DrugDevelopment, #FDA, #FastTrack, #Pharmaceuticals, #Health, #MedicalResearch, #Covid19, #ChronicIllness, #Medicine, #Healthcare, #ScientificResearch, #NewDrugApplication, #FibromyalgiaTreatment#invest #investing #investment #investor #stockmarket #stocks #stock #stockmarketnews

Tonix Pharmaceuticals CEO Dr. Seth Lederman joined Steve Darling from Proactive to share exciting news about a significant achievement for the company. Tonix Pharmaceuticals has been awarded a potential contract worth up to $34 million over five years by the Defense Threat Reduction Agency (DTRA), an agency within the U.S. Department of Defense. This contract aims to develop small molecule broad-spectrum antiviral agents for the prevention or treatment of infections, thereby enhancing the medical readiness of military personnel in biological threat environments. Dr. Lederman explained that Tonix's program will concentrate on the optimization and development of its TNX-4200 program. The goal is to develop an orally available CD45 antagonist with broad-spectrum efficacy against various viral families through extensive preclinical evaluation. The program is expected to establish essential physicochemical properties, pharmacokinetics, and safety attributes to support an Investigational New Drug (IND) submission, ultimately funding a first-in-human Phase 1 clinical study. The agreement with DTRA is a strategic move to address the DoD's objective of protecting U.S. Joint Forces from potential biological weapon threats. The DoD announced in December 2022 that it aims to move beyond the traditional ‘one bug, one drug' approach and is seeking broad-spectrum drugs, as predicting which viruses or how many may be deployed in a biological threat scenario is challenging. Dr. Lederman emphasized that the collaboration with DTRA underscores Tonix Pharmaceuticals' commitment to advancing medical readiness and protection for military personnel. By developing a broad-spectrum antiviral agent, Tonix aims to provide a versatile and robust solution to potential viral threats, enhancing the preparedness and resilience of the U.S. military in diverse and unpredictable biological threat environments. The TNX-4200 program's focus on creating an effective, orally available antiviral agent highlights Tonix's innovative approach to addressing complex medical challenges. The successful development of this broad-spectrum antiviral could significantly impact the way viral infections are managed in military and potentially civilian populations, offering a proactive measure against a wide array of viral threats. Tonix Pharmaceuticals continues to be at the forefront of medical innovation, dedicated to developing cutting-edge solutions that meet the evolving needs of the healthcare and defense sectors. The support from the DoD through this substantial contract is a testament to the potential and importance of Tonix's TNX-4200 program in safeguarding the health and readiness of military personnel against biological threats. #proactiveinvestors #tonixpharmaceuticalsholdingcorp #nasdaq #tnxp #BroadSpectrumAntiviral, #USDepartmentOfDefense, #BiologicalWarfare, #DrugDevelopment, #ImmuneSystem, #SyntheticBiology, #VirusResearch, #InfectiousDisease, #R&D, #FrederickMaryland, #PharmaceuticalInnovation, #HealthcareTechnology, #Biotech, #MedicalResearch, #DefenseContract, #AntiviralAgent, #Healthcare, #PandemicPreparedness, #ScientificResearch#invest #investing #investment #investor #stockmarket #stocks #stock #stockmarketnews

Tonix Pharmaceuticals CEO Dr. Seth Lederman joined Steve Darling from Proactive to announce the receipt of formal minutes from a pre-New Drug Application (NDA) meeting with the U.S. FDA regarding Tonmya sublingual tablets, which is aimed at managing fibromyalgia. This significant development marks a crucial step forward in the regulatory process for Tonmya™. During the meeting, both the Company and the FDA concurred that the proposed data package is comprehensive and sufficient to support the NDA submission. Tonix Pharmaceuticals has reaffirmed its plan to submit the NDA for Tonmya to the FDA in the second half of 2024. If the submission proceeds as planned, it could pave the way for a potential FDA approval in the second half of 2025. Dr. Lederman highlighted the promising potential of Tonmya to benefit fibromyalgia patients, a demographic that frequently expresses dissatisfaction with existing treatment options. Many patients currently resort to using off-label treatments, including addictive and detrimental opioids, due to the lack of effective alternatives. The positive outcomes from the pre-NDA meeting underscore the robustness and completeness of the data package that supports the registration of Tonmya for the management of fibromyalgia. Tonix Pharmaceuticals is optimistic about the impact that Tonmya could have on the fibromyalgia treatment landscape. The company's focus remains on advancing this promising therapy through the regulatory process and ultimately providing a new, effective option for patients struggling with this challenging condition. #proactiveinvestors #tonixpharmaceuticalsholdingcorp #nasdaq #tnxp #Fibromyalgia, #FDAApproval, #DrugDevelopment, #ClinicalTrials, #TanMeyer, #Phase3Studies, #NDA, #NewDrugApplication, #FibromyalgiaTreatment, #MedicalResearch, #PharmaceuticalNews, #Biotechnology, #ChronicPain, #InnovativeTherapies, #HealthNews, #SethLederman, #FDAFeedback, #MedicalBreakthrough, #DrugApprovalProcess#invest #investing #investment #investor #stockmarket #stocks #stock #stockmarketnews

Tonix Pharmaceuticals CEO Dr. Seth Lederman joined Steve Darling from Proactive to announce the completion of the initial phase of an assessment conducted by EVERSANA® Life Science Services, LLC on the U.S. market opportunity for Tonmya. Tonmya represents a potential groundbreaking first-line therapy for fibromyalgia management, positioning itself as a non-opioid, centrally-acting alternative in a market dominated by opioids. Lederman highlighted the concerning dominance of opioids in the fibromyalgia prescription market, despite well-documented risks of dependency. Tonmya aims to address this gap by offering a safer, non-addictive option for fibromyalgia patients. EVERSANA's primary market research indicates promising interest from physicians, with a median interest rating of 4.0 on a 5-point scale and an intended use of Tonmya in 40% of fibromyalgia patients upon approval. The analysis also noted that approximately 50% of fibromyalgia patients in the U.S. are on Medicare. The Inflation Reduction Act, effective in 2025, will cap out-of-pocket prescription drug costs for Medicare patients, which could improve access to Tonmya if approved. With the submission of the New Drug Application (NDA) for Tonmya slated for the second half of the year, Tonix Pharmaceuticals anticipates an FDA decision on approval by 2025. #proactiveinvestors #tonixpharmaceuticalsholdingcorp #nasdaq #tnxp #TonixPharmaceuticals, #FibromyalgiaTreatment, #NewDrugApplication, #TunMyo, #NonOpiateAnalgesic, #ChronicPain, #MarketAssessment, #SanaLifeSciences, #PhaseThreeStudies, #Cyclobenzaprine, #FibromyalgiaAwareness, #BiotechNews, #DrugDevelopment, #PainManagement, #HealthcareInnovation, #Medicare, #InflationReductionAct, #PrescriptionDrugCosts, #PharmaceuticalResearch, #FDAApproval #invest #investing #investment #investor #stockmarket #stocks #stock #stockmarketnews

Tonix Pharmaceuticals CEO Dr. Seth Lederman joined Steve Darling from Proactive to share significant news regarding the company's latest development: the clearance of the Investigational New Drug application by the U.S. Food and Drug Administration for the Phase 2 investigator-initiated OASIS trial. This trial aims to evaluate the efficacy of TNX-102 SL in reducing the severity of acute stress reaction and the frequency of acute stress disorder and post traumatic stress disorder. Dr. Lederman explained that the trial is sponsored by The University of North Carolina Institute for Trauma Recovery and is supported by a substantial 3 million dollar grant from the U.S. Department of Defense. The primary objective of the trial is to assess the safety and efficacy of TNX-102 SL in mitigating adverse posttraumatic neuropsychiatric effects among patients who present to the emergency department following a motor vehicle collision. The trial is expected to enroll approximately 180 trauma survivors across various emergency department study sites throughout the United States. Participants will be randomly assigned to receive either TNX-102 SL 5.6 mg or a placebo for a two-week course. Notably, there is currently a lack of medication available at or near the point-of-care to effectively address the needs of patients suffering from traumatic events and support their long-term health. This development underscores Tonix Pharmaceuticals' commitment to addressing unmet medical needs in the field of trauma recovery and psychiatric disorders. With the initiation of the OASIS trial, the company aims to contribute to the advancement of treatment options for individuals experiencing acute stress reactions and related neuropsychiatric sequelae following traumatic events. Stay tuned for further updates as the trial progresses and Tonix Pharmaceuticals continues its efforts to improve patient outcomes in this critical area of healthcare. #proactiveinvestors #tonixpharmaceuticalsholdingcorp #nasdaq #tnxp #clinicaltrial, #PTSD, #fibromyalgia, #FDAapproval, #healthcare, #medicalresearch, #mentalhealth, #trauma, #pharmaceuticals, #drugdevelopment, #USDepartmentofDefense, #emergencyrooms, #UNC, #longCOVID, #innovation, #treatment, #medicine, #healthtech, #wellness, #researchstudy, #biotech, #drugdiscovery #invest #investing #investment #investor #stockmarket #stocks #stock #stockmarketnews #invest #investing #investment #investor #stockmarket #stocks #stock #stockmarketnews

Tonix Pharmaceuticals CEO Dr. Seth Lederman joined Steve Darling from Proactive to share significant news regarding the company's latest development: the clearance of the Investigational New Drug application by the U.S. Food and Drug Administration for the Phase 2 investigator-initiated OASIS trial. This trial aims to evaluate the efficacy of TNX-102 SL in reducing the severity of acute stress reaction and the frequency of acute stress disorder and posttraumatic stress disorder. Dr. Lederman explained that the trial is sponsored by The University of North Carolina Institute for Trauma Recovery and is supported by a substantial 3 million dollar grant from the U.S. Department of Defense. The primary objective of the trial is to assess the safety and efficacy of TNX-102 SL in mitigating adverse posttraumatic neuropsychiatric effects among patients who present to the emergency department following a motor vehicle collision. The trial is expected to enroll approximately 180 trauma survivors across various emergency department study sites throughout the United States. Participants will be randomly assigned to receive either TNX-102 SL 5.6 mg or a placebo for a two-week course. Notably, there is currently a lack of medication available at or near the point-of-care to effectively address the needs of patients suffering from traumatic events and support their long-term health. This development underscores Tonix Pharmaceuticals' commitment to addressing unmet medical needs in the field of trauma recovery and psychiatric disorders. With the initiation of the OASIS trial, the company aims to contribute to the advancement of treatment options for individuals experiencing acute stress reactions and related neuropsychiatric sequelae following traumatic events. Stay tuned for further updates as the trial progresses and Tonix Pharmaceuticals continues its efforts to improve patient outcomes in this critical area of healthcare. #proactiveinvestors #tonixpharmaceuticalsholdingcorp #nasdaq #tnxp #clinicaltrial, #PTSD, #fibromyalgia, #FDAapproval, #healthcare, #medicalresearch, #mentalhealth, #trauma, #pharmaceuticals, #drugdevelopment, #USDepartmentofDefense, #emergencyrooms, #UNC, #longCOVID, #innovation, #treatment, #medicine, #healthtech, #wellness, #researchstudy, #biotech, #drugdiscovery #invest #investing #investment #investor #stockmarket #stocks #stock #stockmarketnews #invest #investing #investment #investor #stockmarket #stocks #stock #stockmarketnews

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in the Pharma and Biotech world. Sarepta Therapeutics has released data on its new drug for Duchenne muscular dystrophy, showing potent boosting of dystrophin protein production. However, some side effects, including electrolyte imbalances, were also highlighted. Astrazeneca and Daiichi are seeking FDA approval for their drug Enhertu as a "tumor agnostic" treatment, and the FDA is currently reviewing their application. Bristol Myers has received positive data from a trial of a subcutaneous formulation of Opdivo in kidney cancer, showing similar efficacy to the intravenous formulation. Biotech IPOs continue to be an important source of funding for the industry, with Alto Neuroscience and Fractyl Health preparing for initial stock offerings. Merck Manuals is focusing on a "one health" approach, integrating human, animal, and environmental health in medical education and practice.Philips has announced that it will stop selling sleep and respiratory devices in the US due to a consent decree from the FDA. This decision comes as Philips faces regulatory scrutiny and potential legal action related to quality issues with its sleep apnea devices. Medical device companies Stryker, Boston Scientific, and BD are set to post their earnings this week. Absolutions has received FDA breakthrough designation for its abdominal wall closure device, aiming to reduce the risk of hernia by distributing suture tension over a large area of tissue. Globus has laid off employees from NuVasive following their merger. Masimo has forced Apple to redesign its smartwatches in a long-running patent dispute.The pharmaceutical industry is in a race to develop groundbreaking drugs for pain relief. Tanezumab, developed by Eli Lilly and Pfizer, was dropped due to safety concerns. Attention has turned to Vertex Pharmaceuticals' candidate vx-548, which has shown positive results in phase 2 trials for chronic nerve pain. South Rampart Pharma has won fast track designation for its novel drug that activates pain signaling pathways without causing liver and kidney toxicities. Tonix Pharmaceuticals is repurposing an existing technology for the treatment of fibromyalgia, with positive late-stage results. These developments offer hope for patients suffering from chronic pain conditions and could generate significant revenue for the companies involved.Overall, these developments highlight ongoing challenges and changes in the medtech industry, including regulatory scrutiny, mergers, and patent disputes. Medtech companies must navigate these complexities while leveraging connected ecosystems, data, and strategic planning to drive innovation in healthcare.Thank you for tuning in to Pharma and Biotech daily. Stay informed, stay ahead.

Tonix Pharmaceuticals CEO Dr. Seth Lederman joined Steve Darling from Proactive to share additional safety and tolerability data from RESILIENT, the second positive Phase 3 study evaluating TNX-102 SL for the management of fibromyalgia. Dr. Lederman reported that the results from the study showed that TNX-102 SL treatment was not associated with increases in systolic or diastolic blood pressure or body weight. Additionally, there were no reported sexual side effects. In fact, when systematically investigated using the Changes in Sexual Functioning Questionnaire short form, women who received the study drug had a higher CSFQ-14 score compared to those who received a placebo, indicating improved sexual function. These findings are significant for fibromyalgia patients who require long-term therapies, particularly since weight gain is associated with gabapentinoids, negative sexual side effects are linked to serotonin-reuptake inhibiting medications, and increased blood pressure is a concern with potent noradrenergic-reuptake inhibiting medications. Dr. Lederman highlighted that Tonix Pharmaceuticals' work in this field may present an opportunity to launch the first FDA-approved drug for fibromyalgia in more than a decade. This news underscores the potential for TNX-102 SL to offer improved treatment options and quality of life for individuals suffering from fibromyalgia, a condition with limited therapeutic choices. #proactiveinvestors #tonixpharmaceuticalsholdingcorp #nasdaq #tnxp #FibromyalgiaTreatment, #TandX102SL, #MedicalInnovation, #HealthcareNews, #FDAApproval, #ChronicPainRelief, #ClinicalTrials, #HealthTech, #InnovativeMedicine, #PainManagement, #MedicalBreakthrough, #FibromyalgiaAwareness, #HealthResearch, #DrugDevelopment, #PatientCare, #MedicalScience, #WellnessJourney, #HealthUpdates, #MedicalAdvancements, #CEOInterview, #HealthIndustry, #DrugSafety, #MedicalResults, #HealthTechRevolution #invest #investing #investment #investor #stockmarket #stocks #stock #stockmarketnews

Tonix Pharmaceuticals CEO Dr. Seth Lederman recently recently shared groundbreaking news during an interview with Steve Darling from Proactive. The company has achieved highly positive results in their clinical trial targeting Fibromyalgia, a chronic pain disorder affecting approximately 10 million Americans and for which satisfactory treatments are often lacking. TNX 102 SL, Tonix's drug candidate, demonstrated remarkable efficacy in the second phase three clinical trial. The primary pain endpoint achieved an exceptionally low p-value of 0.00005. What's even more promising is that TNX 102 SL is a non-opioid medication with no recognized addictive potential. In addition to addressing pain, the drug also effectively tackled other Fibromyalgia symptoms such as fatigue and sleep disturbances. Lederman informed Proactive that the company's next steps involve filing a new drug application (NDA) for FDA approval. They anticipate a pre-NDA meeting scheduled for the first half of 2024. This groundbreaking development places Tonix Pharmaceuticals at the forefront of Fibromyalgia treatment innovation, providing hope to millions of individuals suffering from the condition. Further updates on this transformative drug are eagerly anticipated in 2024. #proactiveinvestors #tonixpharmaceuticalsholdingcorp #nasdaq #tnxp #FibromyalgiaTreatment #HealthcareInnovation #ChronicPainRelief #TNX102SL #MedicalBreakthrough #ClinicalTrialSuccess #FDAApprovalJourney #PainManagement #HealthTechNews #DrugDevelopment #MedicalResearchUpdate #InnovativeMedicine #FightingFibromyalgia #NonOpioidSolution #MedicalAdvancements #PatientCare #HopeForHealth #PainFreeLiving #WellnessJourney #FutureOfMedicine #ScientificDiscovery #ClinicalTrialResults #CEOInterview #2025LaunchDate#invest #investing #investment #investor #stockmarket #stocks #stock #stockmarketnews

Tonix Pharmaceuticals CEO Dr. Seth Lederman recently joined Steve Darling from Proactive to delving into the significant development involving the U.S. Food and Drug Administration's (FDA) clearance of the Investigational New Drug (IND) application for TNX-2900. This innovative drug represents a proprietary magnesium-enhanced formulation of intranasal oxytocin, designed to address Prader-Willi syndrome (PWS) in children and adolescents. Dr. Lederman was quick to highlight the importance of this milestone, noting that TNX-2900 had already been granted Orphan Drug designation by the FDA back in 2022. The IND clearance paves the way for a crucial Phase 2 study, aimed at determining the optimal dosage for TNX-2900 in treating PWS. This study will involve approximately 36 PWS patients, thoughtfully divided into four distinct groups, each comprising around nine patients. Within these groups, one will receive a placebo, while the remaining three will be administered varying dosage regimens of TNX-2900. Tonix Pharmaceuticals' strategic plan includes the intention to collaborate with a partner to further advance TNX-2900 through its clinical development for PWS. This collaborative effort underscores the commitment to addressing a pressing medical need, as PWS stands out as the most common genetic cause of life-threatening childhood obesity. Importantly, PWS affects both males and females equally, spanning all races and ethnicities. This complex syndrome arises due to the absence of expression of specific genes located on the paternally acquired chromosome 15. In essence, this groundbreaking development in the treatment of Prader-Willi syndrome represents a significant step forward in the pursuit of better outcomes for children and adolescents grappling with this challenging condition, demonstrating Tonix Pharmaceuticals' dedication to advancing medical science and improving the lives of those affected by rare diseases. #proactiveinvestors #tonixpharmaceuticalsholdingcorp #nasdaq #tnxp #PraderWilliSyndrome #MedicalInnovation #HealthcareNews #ClinicalTrials #DrugDevelopment #OxytocinResearch #MagnesiumFormulation #RareDiseaseAwareness #OrphanCondition #HealthTech #PediatricHealth #GeneticDisorders #SethLetterman #Phase2Trial #InnovativeMedicine #MedicalBreakthrough #PatientCare #ScientificAdvancements #HealthScience #TreatmentOptions #WellnessJourney #ResearchUpdate #MedicalDiscovery #FutureOfMedicine #invest #investing #investment #investor #stockmarket #stocks #stock #stockmarketnews

Tonix Pharmaceuticals CEO Dr. Seth Lederman recently joined Steve Darling from Proactive to share exciting news about their COVID vaccine, TNX-1800, selected for testing in Project Next Gen, a White House initiative managed by the Department of Health and Human Services, NIH, and NIAID. The vaccine is based on a live virus platform, providing a unique approach to waking up the immune system. Live virus vaccines, like TNX-1800, offer more durable immunity that lasts a long time and can potentially block virus transmission, addressing limitations seen in mRNA vaccines. This choice of TNX-1800 is a testament to Tonix's nearly decade-long dedication to vaccine development. The technology platform can also be adapted to protect against other infectious diseases, such as monkeypox, smallpox, and tuberculosis, making it a versatile solution for future pandemics. This development highlights the significance of vaccine platforms for tackling various infectious threats. Tonix's approach promises to offer more robust, long-lasting immunity and potential transmission prevention, which could revolutionize our approach to infectious disease control. The platform's adaptability positions it as a valuable tool for future vaccine strategies. #proactiveinvestors #tonixpharmaceuticalsholdingcorp #nasdaq #tnxp#TonixPharmaceuticals #COVIDVaccine #TNX1800 #NextGenVaccines #LiveVirusVaccine #DurableImmunity #InfectiousDisease #PandemicResponse #VaccineTechnology #PublicHealth #HealthcareInnovation #VaccineDevelopment #NIAID #NIH #HealthNews #MedicalResearch #VaccinePlatform #ImmuneResponse #InfectiousThreats #LongLastingProtection #ViralTransmission #SethLetterman #MedicalInnovation #ScienceNews #FutureVaccines #PandemicPrevention #invest #investing #investment #investor #stockmarket #stocks #stock #stockmarketnews

Tonix Pharmaceuticals CEO Dr. Seth Lederman recently joined Steve Darling from Proactive to shed light on the latest developments in their research efforts. The company has successfully concluded the clinical phase of a Phase 3 registration-quality study for TNX-102 SL, a drug developed for the management of fibromyalgia. This study, which is double-blind and placebo-controlled, saw the enrollment of 457 patients across various sites in the United States. Lederman conveyed to Proactive that the topline results from this study are anticipated by late December. Should the results be favorable, this trial is expected to be the conclusive well-controlled efficacy trial needed for the submission of a New Drug Application to the U.S. Food and Drug Administration. The urgency and importance of this development are underscored by the fact that an estimated 6-12 million individuals in the U.S. are afflicted with fibromyalgia, a condition that predominantly affects women. In addition to the TNX-102 study, Lederman also discussed another significant milestone: the enrollment of the first participant in a Phase 2 study, supported by the Department of Defense, focusing on TNX-1900 for the improvement of bone health in children with autism spectrum disorder. This investigator-initiated trial represents a foray into addressing the complex needs of children with autism, potentially offering a new therapeutic avenue to enhance their quality of life. #proactiveinvestors #tonixpharmaceuticalsholdingcorp #nasdaq #tnxp #FibromyalgiaTreatment, #TNX102, #MedicalBreakthroughs, #HealthcareInnovation, #ClinicalTrialsUpdate, #AutismResearch, #BoneHealth, #DrugDevelopment, #FDAApprovalProcess, #HealthNews, #MedicalAdvancements, #PharmaceuticalIndustry, #IntranasalOxytocin, #CEOInterview, #MedicalScience, #ResearchUpdate, #HealthTech, #FutureOfMedicine, #DrugDiscovery, #ScienceAndHealth, #ClinicalStudies, #InnovationInMedicine, #MedicalBreakthroughs2023 #invest #investing #investment #investor #stockmarket #stocks #stock #stockmarketnews

On this week's Biotech Hangout, guest Frank David, Tufts Professor & Author, joins Daphne Zohar, Chris Garabedian, Dawn Bell and Brian Skorney to discuss the latest biotech news. Following recent news from several “Hub & Spoke” companies, including raises from Apollo, Nimbus & Star Therapeutics, the hosts discuss this innovative business model. They also cover M&A news, including the FTC's approval of Amgen's acquisition of Horizon Therapeutics and Nestle's decision to sell the peanut allergy drug it acquired for $2.6B for an undisclosed upfront payment. Other big topics include the 10 drugs announced for Medicare negotiations. Additional themes include the IPO landscape from the ECM, private and crossover perspectives, CymaBay data, Applied Therapeutics FDA meeting & implications for orphan diseases, and Tonix Pharmaceuticals' data. *This episode aired on September 8, 2023

Tonix Pharmaceuticals CEO Seth Lederman joins Natalie Stoberman from the Proactive studios to discuss the acquisition of two migraine products from Upsher-Smith Laboratories. Lederman says Tonix is acquiring Zembrace SymTouch 3 mg and Tosymra 10 mg. He explains that for adults needing acute treatment of migraine, Zembrace SymTouch and Tosymra have the potential to be first-line treatments or ‘rescue' medications for breakthrough migraines due to their fast onset of action and high pain-relief rates. Lederman adds that this strategic move aligns with plans to develop a commercial organization for the company's Fibromyalgia program. #ProactiveInterview #TonixPharmaceuticals #MigraineTreatment #Fibromyalgia #HealthcareNews #PharmaceuticalIndustry #AcuteMigraines #Sumatriptan #MedicalBreakthrough #MigraineRelief #PharmaceuticalAcquisition #DrugDevelopment #CommercialOrganization #HealthTech #MigraineAwareness #MedicationOptions #ChronicMigraines #InnovationInMedicine #MedicalResearch #PatientCare #HeadacheRelief #HealthandWellness #Neurology #MedicalAdvancements #HealthScience #MigrainePrevention #HealthcareSolutions #invest #investing #investment #investor #stockmarket #stocks #stock #stockmarketnews

Tonix Pharmaceuticals CEO Seth Lederman joins Natalie Stoberman from the Proactive newsroom to discuss the recent publication of the company's Phase 3 study on TNX-102 SL for fibromyalgia management in the American College of Rheumatology. Lederman says the article outlined how the study's results showed improvements in widespread pain and fatigue, which are significant symptoms of fibromyalgia. He explains that TNX-102 SL, a sublingual tablet taken at bedtime, targets sleep quality to enhance overall fibromyalgia symptoms. With the upcoming confirmatory Phase 3 trial results, Lederman says Tonix aims to file a new drug application for TNX-102 SL. #ProactiveInvestors #TonixPharmaceuticals #FibromyalgiaTreatment #MedicalBreakthrough #TNX102SL #ChronicPainRelief #FibromyalgiaAwareness #SleepQualityImprovement #PatientSatisfaction #InnovativeMedicine #RheumatologyResearch #FibromyalgiaManagement #NewDrugApplication #PhaseThreeStudy #HealthcareAdvancements #SublingualTablet #ImprovedQualityofLife #AlternativeFibromyalgiaTreatment #FibromyalgiaSupport #PatientCare #ClinicalTrials #MedicalInnovation #HolisticHealth #PainManagement #BrainFogRelief #FatigueReduction #MedicalJournalPublication #TonixPharmaceuticals #invest #investing #investment #investor #stockmarket #stocks #stock #stockmarketnews

Parder-Willi syndrome is a rare, genetic disease that is characterized, in part, by hyperphagia—an intense and insatiable hunger. People with the condition are driven to constantly eat and seek out food. The syndrome is associated with severe obesity and obesity-related mortality. Tonix Pharmaceuticals is developing an experimental oxytocin nasal spray to treat hyperphagia in people with Prader-Willi syndrome. The approach, to date, has shown promise in animal models. We spoke to Seth Lederman, CEO of Tonix, about Prader-Willi syndrome, the unmet need for treatments, and why he believes an oxytocin nasal spray has potential to treat the condition.

On this week's Tech Nation, Moira speaks with Dr. Seth Lederman, the Co-Founder and CEO of Tonix Pharmaceuticals, about Long Covid – and it potential relation to another medical condition, Fibromyalgia. Tonix is now recruiting subjects for advanced Human Clinical Trials in both. Then neuroscientist and psychologist Lisa Feldman Barrett gives us a lesson or two from her book, “7½ Lessons about the Brain”.

This is the latest episode of the free DDW podcast, which covers three articles written for Volume 22, Issue 4 – Fall 2021 of DDW, narrated by DDW Multimedia Editor Megan Thomas. They are called “The potential of small molecules and biologics for new therapeutics”, “AE reporting turnarounds and the translation issue” and “Why we are on the cusp of a golden age of medicine”. Dr Seth Lederman is a physician-scientist, entrepreneur, and CEO of Tonix Pharmaceuticals. In the first article, he talks to Lu Rahman about Tonix Pharmaceuticals' mission to research and manufacture small molecules and biologics for the treatment of CNS and immunological conditions. In the second article, Kathleen O'Brien of Amplexor Life Sciences lays out a blueprint for centralising global AE reporting. In the third article, Panna Sharma, the President and CEO of Lantern Pharma, a clinical-stage oncology biotech using AI and genomics to innovate the rescue, revitalisation, and development of precision cancer therapeutics, spoke to Lu Rahman about this biotech and explains why he believes AI is about to change the drug development landscape.

Tonix Pharmaceuticals (NASDAQ:TNXP) CEO Seth Lederman joins Proactive's Stephen Gunnion with the news that the US Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application to support a Phase 2 clinical trial with TNX-601 ER. Lederman explains that TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily formulation of tianeptine as a potential treatment for major depressive disorder (MDD). He said the IND application is an important milestone as the company advances TNX-601 ER into clinical development, with the phase Phase 2 trial in MDD expected to start in the first quarter of 2023. #ProactiveInvestors #TonixPharmaceuticals #MajorDepressiveDisorder #TNX601 #Nasdaq

Tonix Pharmaceuticals CEO Seth Lederman joined Proactive's Stephen Gunnion with news that the company has a monkeypox vaccine in development. Declared a public health emergency by the US government last week, Lederman told Proactive that Tonix has been working on TNX-801, which prevents smallpox and monkeypox, for 10 years. "We are excited about the prospect of getting involved in the monkeypox crisis right now," Lederman said. Lederman also discuss recent news that Tonix Pharmaceuticals has received a grant from the National Institute on Drug Abuse to support development of its treatment of cocaine intoxication.

What is monkeypox and how did it get here?We're talking about the monkeypox virus: its incubation period, symptoms, transmission, how contagious it is, treatment and mortality rate. It's similar to smallpox, which only two countries are officially in possession of WHO authorized smallpox repositories of. Iraq, North Korea and France are also believed to possess “illegal” stockpiles. If you enjoy our content, become a patron and unlock our premium episodes. 1 We discuss how Russia produced tons of biological weapons using similar plagues. As Pulitzer Prize winner Ed Yong of The Atlantic said, “The US has spent decades thinking about how to handle smallpox bioterrorism. The two cases of monkeypox in 2021 provided handy test runs for those plans.” The State Centre for Research on Virology and Biotechnology in Novosibirsk called Vector is in possession of smallpox and anthrax, as well as more recent pathogens like Ebola. 2 Smallpox had a 30% fatality rate at its peak. Monkeypox is between 1-10% depending on the strain and care available. The COVID SARS 2 R0 is 8. Monkeypox's R naught is less than 1 (average) so far. R0 is the average number of people who will contract a disease from one person with that disease. Although it's rare, if you have swollen lymph nodes, fever, headaches, pustules, puss filled blisters, or lesions on your hands and feet, extremities, and face you should probably head to the ER... Monkeypox is transmitted by bodily fluids. It is not an airborne virus like COVID, monkeypox is also a DNA virus so it doesn't mutate easily. The virus is mostly carried by rodents. In 2003 USA had a monkeypox outbreak in Illinois after an import of rodents from Ghana. What's different now is so many cases without a clear prime source. Rarely, monkeypox makes away from it's endemic areas in Nigeria, Ghana, and Congo. When it does,outbreaks are usually in the single digits, not this time. On May 20th confirmed cases were in the US, UK, Spain, and Portugal. As we record on May 24, monkeypox is in all NATO countries plus a few. Those first affected were men who have sex with men. It is important to not stigmatize any group of people. Early narratives about a disease can become lore. And narratives turned stigma can stop people from reporting symptoms. Stigma and disinformation is exactly what evangelical Republicans and the Russian orthodox church will likely do, though. We discuss Russian experiments with Marburg, Ebola, bubonic plague, anthrax, HIV, and camelpox. Catherine the Great was the first Russian vaccinated for smallpox, and all these years later this outbreak has the stocks of companies with an interest in vaccines like TPOXX and TEMBEXA such as Siga, Tonix Pharmaceuticals, Emergent BioSolutions, and Bavarian Nordic soaring. We discuss Vektor Labs in Koltsovo, Siberia (as well as its predecessor, Biopreparat) where Putin's doctors work on the latest vaccines... they say... maybe also bioweapons. Ilya Drozdov was in charge of Vector, but he's now the world's most famous missing scientist, either accidentally or on purpose. If there is still a Russian bioweapons program they're in volation of the Biological Weapons Convention. Vector is the second largest such facility in the world behind the Wuhan Institute of Virology in China. Our Russian bioweapons history knowledge mostly comes from defector Ken Alibek who testified about his time in Russian bioweapons research before Congress. 1. Mary G. Reynolds et al. ...Risk Factors for Human Monkeypox.... Emerging Infectious Diseases. Vol 13, November 2007. ⇤2. Ed Yong. So Have You Heard About Monkeypox?. The Atlantic. May 2022. ⇤

As COVID-19 cases climb yet again,  the Business of Biotech catches up with Tonix Pharmaceuticals CEO Seth Lederman, M.D. for a conversation on his company's multi-pronged strategy to advance vaccine and therapeutic candidates to address the disease and its variants. In addition to sharing on his journey from academia to industry, Dr. Lederman discusses his company's approach to grabbing its share of the highly competitive, and highly lucrative, vaccine market.

Tonix Pharmaceuticals Holding Corp. CEO Seth Lederman talks to Proactive about the New Jersey-based clinical-stage biopharmaceutical company's 2021 highlights. Lederman says the group ended the year with $179 million in cash and cash equivalents, entering 2022 'poised for growth.' Lederman highlights the FDA's recent award of Orphan-Drug designation for Tonix's TNX-2900 to treat Prader Willi syndrome, among other milestones.

Dr. Seth Lederman, CEO and Chairman of Tonix Pharmaceuticals, discusses the need for a diversity of approaches when developing Covid vaccines. Bloomberg Businessweek Editor Joel Weber and Bloomberg News Senior Management and Workplace Reporter Matt Boyle talk about Matt's Businessweek Magazine story RTO Industrial Complex Is Best Thing for Consultants Since Y2K. David Riedel, President of Riedel Research Group, shares his thoughts on China drafting regulations to effectively ban Chinese companies from going public on foreign markets. Bloomberg News Senior Editor Chris Anstey explains why Peter Lynch says all-in on passive investing is all wrong. And we Drive to the Close with Ken Van Leeuwen, CEO of Van Leeuwen & Company. Hosts: Carol Massar and Tim Stenovec. Producer: Paul Brennan. Learn more about your ad-choices at https://www.iheartpodcastnetwork.com

Dr. Seth Lederman, CEO and Chairman of Tonix Pharmaceuticals, discusses the need for a diversity of approaches when developing Covid vaccines. Bloomberg Businessweek Editor Joel Weber and Bloomberg News Senior Management and Workplace Reporter Matt Boyle talk about Matt's Businessweek Magazine story RTO Industrial Complex Is Best Thing for Consultants Since Y2K. David Riedel, President of Riedel Research Group, shares his thoughts on China drafting regulations to effectively ban Chinese companies from going public on foreign markets. Bloomberg News Senior Editor Chris Anstey explains why Peter Lynch says all-in on passive investing is all wrong. And we Drive to the Close with Ken Van Leeuwen, CEO of Van Leeuwen & Company. Hosts: Carol Massar and Tim Stenovec. Producer: Paul Brennan. Learn more about your ad-choices at https://www.iheartpodcastnetwork.com

Seth Lederman is the CEO of Tonix Pharmaceuticals and a physician scientist with a two decades of research experience. Prior to becoming an entrepreneur, he was an Associate Professor at Columbia University. Dr. Lederman's groundbreaking research led to the discovery of the CD-40 ligand and its role in T cell helper function. Currently, Dr. Lederman oversees Tonix Pharmaceuticals and its diverse programs that are aimed to develop therapeutics for chronic CNS and immunologic conditions, that include indications like fibromyalgia, Covid-19 and Long Covid, amongst others. Dr. Lederman earned an AB from Princeton University in Chemistry and an MD from Columbia University's College of Physicians and Surgeons. Dr. Lederman trained in internal medicine and rheumatology at Columbia's Presbyterian Hospital.https://www.tonixpharma.com/

Dr. Seth Lederman, CEO of Tonix Pharmaceuticals, discusses U.S. regulators granting full approval of the Covid-19 vaccine made by Pfzier and BioNtech, a milestone expected to help bolster the immunization drive. Bloomberg Law Health Care Reporter Shira Stein shares her story Pregnant, Unvaccinated and Intubated: Doctors Alarmed by Rise. Bloomberg Businessweek Editor Joel Weber and Bloomberg Opinion Columnist Brooke Sutherland break down the battle for aerospace and defense supplier Meggitt. Bloomberg News Economics Reporter Rich Miller explains his Bloomberg Big Take story about the Fed's new inflation framework. And we Drive to the Close with Mitch Rubin, Portfolio Manager at RiverPark Funds.  Hosts: Tim Stenovec and Katie Greifeld. Producer: Paul Brennan.  Learn more about your ad-choices at https://www.iheartpodcastnetwork.com

Dr. Seth Lederman, CEO of Tonix Pharmaceuticals, discusses U.S. regulators granting full approval of the Covid-19 vaccine made by Pfzier and BioNtech, a milestone expected to help bolster the immunization drive. Bloomberg Law Health Care Reporter Shira Stein shares her story Pregnant, Unvaccinated and Intubated: Doctors Alarmed by Rise. Bloomberg Businessweek Editor Joel Weber and Bloomberg Opinion Columnist Brooke Sutherland break down the battle for aerospace and defense supplier Meggitt. Bloomberg News Economics Reporter Rich Miller explains his Bloomberg Big Take story about the Fed's new inflation framework. And we Drive to the Close with Mitch Rubin, Portfolio Manager at RiverPark Funds.  Hosts: Tim Stenovec and Katie Greifeld. Producer: Paul Brennan.  Learn more about your ad-choices at https://www.iheartpodcastnetwork.com

Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) CEO Dr Seth Lederman talks to Proactive about how the clinical-stage biopharmaceutical company plans to develop TNX-102 SL as a potential treatment for Long COVID Syndrome, known officially as Post-Acute Sequelae of COVID-19. Dr Lederman says Tonix plans to meet with the FDA in the third quarter of 2021 fo the design of a potential Phase 2 pivotal study for Long COVID.

Dr. Seth Lederman, CEO of Tonix Pharmaceuticals, discusses vaccine development and durability. Bloomberg Businessweek Editor Joel Weber and Bloomberg News Reporter Jim Wyss explain how Cuba is readying homegrown Covid vaccines. IMAX CEO Richard Gelfond talks about stepping up efforts to draw people back into theaters. And we Drive to the Close with Cole Smead, President and Portfolio Manager at Smead Capital. Hosts: Carol Massar and Tim Stenovec. Producer: Paul Brennan. Learn more about your ad-choices at https://www.iheartpodcastnetwork.com

Dr. Seth Lederman, CEO of Tonix Pharmaceuticals, discusses vaccine development and durability. Bloomberg Businessweek Editor Joel Weber and Bloomberg News Reporter Jim Wyss explain how Cuba is readying homegrown Covid vaccines. IMAX CEO Richard Gelfond talks about stepping up efforts to draw people back into theaters. And we Drive to the Close with Cole Smead, President and Portfolio Manager at Smead Capital. Hosts: Carol Massar and Tim Stenovec. Producer: Paul Brennan.

Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) Dr Seth Lederman tells Proactive the clinical-stage biopharmaceutical company has formed an exclusive licensing agreement develop a potential coronavirus treatment, TNX-3500, from OyaGen, Inc. a pre-clinical biotechnology research company. Dr Lederman says in TNX-3500 is '65 times more potent' than Gilead's Remdesivir, in-vitro, at inhibiting the coronavirus. He adds the group is very excited to move TNX-3500 into animal studies, and later clinical testing in humans.

Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) CEO Dr Seth Lederman tells Proactive the clinical-stage biopharmaceutical company has revealed preliminary results of its COVID-19 vaccine candidate. Lederman says its vaccine candidate TNX-1800 had undetectable SARS-CoV-2 within animal models, within upper and lower airways 6 days after injected with SARS-CoV-2.

Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) Dr Seth Lederman spoke to Proactive on the group's financial results for the fourth quarter and full year, along with an update on its second Phase 3 study of fibromyalgia. Dr Lederman says it recently enrolled the first 50% of patients in its RALLY study. The RALLY study uses the same design as the company's first positive Phase 3 study, RELIEF, but with an additional 200 patients. Top-line results are expected by the end of 2021.

Dr. Seth Lederman, CEO at Tonix Pharmaceuticals, discusses continuing clinical trials for Covid vaccines. Bloomberg Businessweek Editor Joel Weber and Bloomberg News U.S. Economy Reporter Olivia Rockeman talks about the unemployment system being plagued by $63 billion in fraud and dysfunction. Nobel Laureate Economist and Columbia University Professor Joseph Stiglitz shares his insight on vaccine equity, debt relief, and fiscal capacity in the developing world. And we Drive to the Close with Kathy Boyle, President at Chapin Hill Advisors. Hosts: Carol Massar and Tim Stenovec. Producer: Doni Holloway. Learn more about your ad-choices at https://www.iheartpodcastnetwork.com

Dr. Seth Lederman, CEO at Tonix Pharmaceuticals, discusses continuing clinical trials for Covid vaccines. Bloomberg Businessweek Editor Joel Weber and Bloomberg News U.S. Economy Reporter Olivia Rockeman talks about the unemployment system being plagued by $63 billion in fraud and dysfunction. Nobel Laureate Economist and Columbia University Professor Joseph Stiglitz shares his insight on vaccine equity, debt relief, and fiscal capacity in the developing world. And we Drive to the Close with Kathy Boyle, President at Chapin Hill Advisors. Hosts: Carol Massar and Tim Stenovec. Producer: Doni Holloway.

The Bitterroot Valley is welcoming a third biotech company: vaccine-developer Tonix Pharmaceuticals announced its plans to build a facility near Hamilton late last year. But to local officials, it's more than a new company. Tonix is the latest development in a decade-long effort to turn this southwest Montana valley into a biotech corridor.

Dr. Seth Lederman, CEO at Tonix Pharmaceuticals, provides a coronavirus and vaccine update. Bloomberg News Health Care Reporter Emma Court talks about why missed doctor visits have created Covid's shadow health crisis. Bloomberg Businessweek Editor Joel Weber and Bloomberg News Technology Reporter Austin Carr discuss the story “Apple Is the $2.3 Trillion Fortress That Tim Cook Built.” Bloomberg News Congressional Tax Reporter Laura Davison walks through Democrats cutting off relief checks at $200,000 in household income. And we Drive to the Close with Eric Clark, Portfolio Manager at Rational Dynamic Brands Fund. Hosts: Carol Massar and Tim Stenovec. Producer: Doni Holloway.  Learn more about your ad-choices at https://www.iheartpodcastnetwork.com

Dr. Seth Lederman, CEO at Tonix Pharmaceuticals, provides a coronavirus and vaccine update. Bloomberg News Health Care Reporter Emma Court talks about why missed doctor visits have created Covid’s shadow health crisis. Bloomberg Businessweek Editor Joel Weber and Bloomberg News Technology Reporter Austin Carr discuss the story “Apple Is the $2.3 Trillion Fortress That Tim Cook Built.” Bloomberg News Congressional Tax Reporter Laura Davison walks through Democrats cutting off relief checks at $200,000 in household income. And we Drive to the Close with Eric Clark, Portfolio Manager at Rational Dynamic Brands Fund. Hosts: Carol Massar and Tim Stenovec. Producer: Doni Holloway. 

Computer Scientist Dr. Lorien Pratt about “Link … How Decision Intelligence Connects Data, Actions, and Outcomes for a Better World.” Then Dr. Seth Lederman, the CEO of Tonix Pharmaceuticals, tells us about how PTSD affects the brain, its relation to sleep, and how it may treated some 9 years after the initial trauma. If you have experienced trauma, and PTSD, you may qualify for one of their clinical studies.

Computer Scientist Dr. Lorien Pratt about “Link … How Decision Intelligence Connects Data, Actions, and Outcomes for a Better World.” Then Dr. Seth Lederman, the CEO of Tonix Pharmaceuticals, tells us about how PTSD affects the brain, its relation to sleep, and how it may treated some 9 years after the initial trauma. If you have experienced trauma, and PTSD, you may qualify for one of their clinical studies.

Dr. Seth Lederman, Co-Founder and CEO of Tonix Pharmaceuticals, details COVID vaccine developments. Bloomberg News Corporate Influence Reporter Naomi Nix talks about Facebook’s monopoly lawsuit. Bloomberg Businessweek Editor Joel Weber and Bloomberg News Technology Reporter Kurt Wagner discuss the story “Facebook’s Next Trick Is to Turn WhatsApp Into a Real Business.” Bloomberg News Congressional Reporter Erik Wasson shares his insight on US Treasury Secretary Steven Mnuchin pitching a $916 billion relief plan including state aid. And we Drive to the Close with Tom Plumb, CIO at Plumb Funds. Host: Carol Massar and Tim Stenovec. Producer: Doni Holloway.

Dr. Seth Lederman, Co-Founder and CEO of Tonix Pharmaceuticals, details COVID vaccine developments. Bloomberg News Corporate Influence Reporter Naomi Nix talks about Facebook's monopoly lawsuit. Bloomberg Businessweek Editor Joel Weber and Bloomberg News Technology Reporter Kurt Wagner discuss the story “Facebook's Next Trick Is to Turn WhatsApp Into a Real Business.” Bloomberg News Congressional Reporter Erik Wasson shares his insight on US Treasury Secretary Steven Mnuchin pitching a $916 billion relief plan including state aid. And we Drive to the Close with Tom Plumb, CIO at Plumb Funds. Host: Carol Massar and Tim Stenovec. Producer: Doni Holloway. Learn more about your ad-choices at https://www.iheartpodcastnetwork.com

In this fireside chat brought to you by Conversations in Healthcare, Mike Ward, Global Head of Thought Leadership at DRG talks to Seth Lederman, co-founder, CEO and chairman of Tonix Pharmaceuticals. Seth and Mike explored the two programs Tonix are currently developing in pain and psychiatry, areas where many larger companies have turned their back due to subjective endpoints. Tonix believes they have developed invaluable expertise to counter these challenges and Seth explains that the difficulty of the endpoints, will be compensated by the importance of bringing new medicines to market that will be significant to the pharmacopeia. Tonix is also working on a vaccine candidate for COVID-19 that is one of only a handful which is a live replicating virus vector platform. Seth discussed what the vaccine landscape might look like once COVID vaccines come to market and the adoption challenges we may face as a society. Seth also touched on the trend currently in the industry of biotechnology companies choosing to commercialise their products, how Tonix intend to do just this and discusses how technology has eroded big pharma's advantage in this area. See acast.com/privacy for privacy and opt-out information.

Dr. Seth Lederman, CEO and Chairman of Tonix Pharmaceuticals, discusses working to develop a COVID-19 vaccine for clinical trials. Bloomberg Businessweek Editor Joel Weber and Bloomberg Finance reporter Michelle Davis walk through the story “PPP Scammers Made Fintech Companies Their Lenders of Choice.” We get Businessweek Economics with Bloomberg New Economy Editorial Director Andy Browne. And we Drive to the Close with JJ Kinahan, Chief Market Strategist at TD Ameritrade. Hosts: Carol Massar and Jason Kelly. Producer: Doni Holloway.  Learn more about your ad-choices at https://www.iheartpodcastnetwork.com

Dr. Seth Lederman, M.D., co-founder, CEO, and chairman of Tonix Pharmaceuticals Holding Corp., discusses their COVID-19 vaccine program based on their proprietary synthetic horsepox vaccine platform, and how they are currently collaborating with Southern Research, Columbia University, and others. Their vaccine is on course to Phase 1 in early 2021.

Dr. Seth Lederman, CEO and Chairman of Tonix Pharmaceuticals, discusses working to develop a COVID-19 vaccine for clinical trials. Bloomberg Businessweek Editor Joel Weber and Bloomberg Finance reporter Michelle Davis walk through the story “PPP Scammers Made Fintech Companies Their Lenders of Choice.” We get Businessweek Economics with Bloomberg New Economy Editorial Director Andy Browne. And we Drive to the Close with JJ Kinahan, Chief Market Strategist at TD Ameritrade. Hosts: Carol Massar and Jason Kelly. Producer: Doni Holloway. 

Seth Lederman is a physician, scientist and founder and executive officer of innovative biopharmaceuticals companies. Prior to founding Tonix, among the companies Dr. Lederman founded was Targent Pharmaceuticals, which developed late-stage oncology drugs, including pure-isomer levofolinic acid (levoleucovorin). Targent’s assets were sold to Spectrum Pharmaceuticals, which marketed levoleucovorin as Fusilev® for advanced colorectal cancer, where it gained significant market acceptance. Dr. Lederman served as an Associate Professor at Columbia University from 1996 until April 13, 2017. He joined the faculty of Columbia University's College of Physicians and Surgeons in 1985, became Assistant Professor of Medicine in 1988, and Associate Professor with tenure in 1996 and Director of the Laboratory of Molecular Immunology in 1997. From 1988 to 2002, Dr. Lederman directed basic science research at Columbia in molecular immunology, infectious diseases and the development of therapeutics for autoimmune diseases. Dr. Lederman is author of numerous scientific articles, and inventor of technologies recognized by a number of issued patents. His fundamental work on the CD40-Ligand (CD154) elucidated the molecular basis of T cell helper function and has led to the development of therapeutic candidates for autoimmune diseases and organ transplant rejection in collaboration with Biogen and UCB. The successful defense of his CD154 patents has led to important precedents in defining the relationship of therapeutics and molecular targets. In collaboration with Prof. David Baltimore (then at Rockefeller University and later MIT), Dr. Lederman identified and functionally characterized the CD40 signaling molecule, TRAF-3. His early work on HIV contributed to the understanding of how the V3 loop of HIV gp120 was involved in fusion with CD4 cell membranes, an early and essential event in viral entry and infection. In addition to his research, Dr. Lederman served as attending physician in the Edward Daniels Arthritis and Autoimmunity Clinic on the Medical Service at Columbia Presbyterian Hospital from 1988-1996. Dr. Lederman represented U.S. Biotechnology at a Beijing Summit in September 2015 with China’s President Xi Jinping. The Summit was organized by the U.S. Chamber of Commerce and involved a delegation of U.S. CEOs, former U.S. Cabinet officials and leading academic experts. Dr. Lederman earned an AB from Princeton in Chemistry cum laude in 1979 and an MD from Columbia University's College of Physicians and Surgeons in 1983. Dr. Lederman trained in internal medicine and rheumatology at Columbia's Presbyterian Hospital. He was an NIH Physician-Scientist 1985-1990 at Columbia.

Dr. Seth Lederman, CEO at Tonix Pharmaceuticals, discusses working on a COVID-19 vaccine. Bloomberg Businessweek Editor Joel Weber and Bloomberg News U.S. Real Estate Reporter Prashant Gopal share their insight on urban exiles fueling a suburban housing boom across the U.S. We get Businessweek Economics with Bloomberg Economics Senior U.S. Economist Yelena Shulyatyeva. She breaks down monthly jobless claims data. And we Drive to the Close with Tom Plumb, Chief Investment Officer at Plumb Funds. Hosts: Carol Massar and Jason Kelly. Producer: Doni Holloway.  Learn more about your ad-choices at https://www.iheartpodcastnetwork.com

Dr. Seth Lederman, CEO at Tonix Pharmaceuticals, discusses working on a COVID-19 vaccine. Bloomberg Businessweek Editor Joel Weber and Bloomberg News U.S. Real Estate Reporter Prashant Gopal share their insight on urban exiles fueling a suburban housing boom across the U.S. We get Businessweek Economics with Bloomberg Economics Senior U.S. Economist Yelena Shulyatyeva. She breaks down monthly jobless claims data. And we Drive to the Close with Tom Plumb, Chief Investment Officer at Plumb Funds. Hosts: Carol Massar and Jason Kelly. Producer: Doni Holloway. 

Seth Lederman, MD, Chief Executive Officer and Founder, Tonix Pharmaceuticals brings us up to speed on the work at Tonix in developing new COVID-19 vaccines based on their live, synthetic horsepox vector system with a focus on vaccinating the subgroup of healthy people who are not pregnant and have a working immune system. Seth talks about the advantages of using live replicating virus vaccines as well as how immuno-oncology is informing their approach to stimulating T-cells to fight infectious diseases. In addition, new medicines are being developed to treat fibromyalgia and PTSD. @TonixPharma #COVID19 #vaccines #PTSD #fibromyalgia #pain TonixPharma.com Download the transcript here

Seth Lederman, MD, Chief Executive Officer and Founder, Tonix Pharmaceuticals brings us up to speed on the work at Tonix in developing new COVID-19 vaccines based on their live, synthetic horsepox vector system with a focus on vaccinating the subgroup of healthy people who are not pregnant and have a working immune system. Seth talks about the advantages of using live replicating virus vaccines as well as how immuno-oncology is informing their approach to stimulating T-cells to fight infectious diseases. In addition, new medicines are being developed to treat fibromyalgia and PTSD. @TonixPharma #COVID19 #vaccines #PTSD #fibromyalgia #pain TonixPharma.com Listen to the podcast here

Dr. Seth Lederman, CEO of Tonix Pharmaceuticals, discusses working to manufacture a COVID-19 vaccine for clinical trial supply. Bloomberg News Vancouver Bureau Chief Natalie Obiko Pearson shares her insight on Shopify enjoying a big moment and and the company's hopes that it will last. Bloomberg News Editor Dimitra Kessenides joins with the Businessweek Small Business Survival Guide, along with Iyesata Marsh, Owner of Studio Phenomenon hair salon. And we Drive to the Close with David Dietze, Chief Investment Strategist at Point View Wealth Management. Hosts: Carol Massar and Jason Kelly. Producer: Doni Holloway. 

Dr. Seth Lederman, CEO of Tonix Pharmaceuticals, discusses working to manufacture a COVID-19 vaccine for clinical trial supply. Bloomberg News Vancouver Bureau Chief Natalie Obiko Pearson shares her insight on Shopify enjoying a big moment and and the company's hopes that it will last. Bloomberg News Editor Dimitra Kessenides joins with the Businessweek Small Business Survival Guide, along with Iyesata Marsh, Owner of Studio Phenomenon hair salon. And we Drive to the Close with David Dietze, Chief Investment Strategist at Point View Wealth Management. Hosts: Carol Massar and Jason Kelly. Producer: Doni Holloway.  Learn more about your ad-choices at https://www.iheartpodcastnetwork.com

On this week’s Tech Nation, Moira speaks with Computer Scientist Dr. Lorien Pratt about “Link … How Decision Intelligence Connects Data, Actions, and Outcomes for a Better World.” Then Dr. Seth Lederman, the CEO of Tonix Pharmaceuticals, tells us about how PTSD affects the brain, its relation to sleep, and how it may treated some 9 years after the initial trauma. If you have experienced trauma, and PTSD, you may qualify for one of their clinical studies.

Pharm Exec editors talk with Seth Lederman, co-founder, CEO and chairman of Tonix Pharmaceuticals about how to navigate creating drugs for conditions such as PTSD and AIDS, running a business, and academia.

On this week’s Tech Nation Health, Moira speaks with … Dr. Seth Lederman from Tonix Pharmaceuticals about military-related PTSD. Their drug has been fast-tracked by the FDA. Then on Tech Nation Health, Chief Correspondent Daniel Kraft with Jordan Amadio about the emergent technology in the field of neurosurgery, and Dr. Elliot Goldstein from ProMIS Neurosciences the particular kind of plaque that brings about Alzheimer’s.

Today in FirstWord: