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Players Health Partners with RealResponse to Enhance Athlete Safety and Wellbeing Through Real-Time Reporting

Players Health

Players Health, the leading provider of athlete safety and insurance solutions, today announced a partnership with RealResponse, a powerful web-based platform where athletes can anonymously report improper conduct through confidential two-way dialogue. Together, the two industry leaders will implement an innovative reporting platform for over five million athletes, leagues, and organizations in the Players Health specialty youth sports insurance ecosystem. This collaboration will blend RealResponse’s multi-channel communication technology into Players Health's sports-centric insurance, education, training, and compliance offerings, empowering kids, parents, guardians, and coaches to share feedback, ask questions, and access resources anonymously and in real-time. The RealResponse platform has already proven effective in facilitating rapid communication across amateur athletics, offering real-time anonymous visibility into critical situations, allowing for timely support for mental health needs. “Everything we do is centered around creating the safest and most accessible environments for amateur athletes to play the sports they love. RealResponse’s integration into our growing community allows us to provide our clients with the protected and secure communication tools needed to achieve clarity when investigating incidents,” said Tyrre Burks, CEO & Founder of Players Health. “This partnership creates a crucial framework for our clients to manage risk effectively and act promptly on valuable feedback.” As part of this partnership, Players Health becomes a preferred insurance, health and safety provider for RealResponse, ensuring that youth sports organizations have access to comprehensive coverage alongside innovative reporting solutions. Conversely, RealResponse will serve as a preferred feedback and anonymous reporting platform for Players Health, reinforcing its commitment to athlete safety and proactive risk management. This strategic alignment will enhance the resources available to organizations, and help foster a culture of safety and accountability across the youth sports ecosystem. “Players Health and RealResponse are committed to empowering amateur sports and educational institutions with innovative technological solutions that resonate with today's youth,” said David Chadwick, Founder and CEO of RealResponse. “By utilizing preferred communication channels—such as text, QR codes and WhatsApp—we're taking significant strides to prevent abuse and misconduct. Our advanced, seamless auto-routing capabilities streamline administrative processes, making it easier for organizations to uphold safety standards while supporting Players Health’s expanding network of clients.” Learn more about the partnership here: https://www.playershealth.com/ Players Health is a sports technology company providing digital risk management services, reporting tools and insurance products to sports organizations to empower them to stay ahead of their ever-changing safety and compliance responsibilities. Working towards establishing the safest environment for athletes, Players Health views the health and safety of athletes as a priority in today's sports landscape. ABOUT REALRESPONSE RealResponse is committed to elevating all voices in sports. The RealResponse community includes more than two million athletes, coaches, administrators, and staff, across college and professional sports, governing bodies, youth organizations, and integrity units. Founded in 2015, RealResponse empowers organizations and individuals to operate confidently in the high-risk world of sports – with real-time, two-way anonymous communications, surveys, compliance support, and data. For more information, visit realresponse.com. Contact Details Digital Sport by Hot Paper Lantern Jackson Gaskins playershealth@hotpaperlantern.com Company Website https://www.playershealth.com

July 24, 2024 08:00 AM Eastern Daylight Time

Heat Stroke and Heat-Related Illness Rapidly Rising as Global Temperatures Climb

Centre for Neuro Skills

The number of people exposed to extreme heat has grown exponentially due to climate change, according to the World Health Organization. The New York Times reported that June 2024 was the 13 th consecutive month to break the global heat record. In 2023, 32 million people across California, Texas and Nevada experienced the hottest summer ever recorded in the United States. Centre for Neuro Skills (CNS), a leading provider of traumatic and acquired brain injury rehabilitation services with seven locations in California and Texas, shares essential tips for heat stroke prevention. Taking proactive measures to avoid heat stroke can be the difference between life and death. To avoid heat stroke: Dress in lightweight, loose-fitting clothing Apply sunscreen to avoid sunburn and keep the body cool Drink plenty of water and avoid sugary or alcoholic drinks Limit time outside to when it is cooler or if you must go out when temperatures are high, rest often Avoid leaving children or animals in parked cars, even if the windows are cracked open Monitor loved ones who are at high risk for developing heat stroke Check local news for extreme heat alerts “Of all the heat-related illnesses, heat stroke is the most serious. Heat stroke occurs when the body is no longer able to regulate temperature and cool down,” said Dr. Gary Seale, Regional Director of Clinical Services at CNS. “Body temperatures can rise rapidly to 104 degrees or higher which can cause damage to organs, including the brain, and result in permanent disability. Heat stroke can cause brain swelling, seizures, and lead to chronic inflammation, all of which disrupt brain function.” Children under 4 years old, adults over 65 years old with illnesses or medications that prevent body temperature regulation and people that are clinically classified as obese are all at higher risk of heat stroke. Heat exhaustion can be caused by engaging in strenuous activity, overexposure to hot weather and humidity and wearing excessive clothing that does not allow sweat to evaporate. Symptoms of heat stroke include high body core temperature, flushed skin, dizziness, loss of consciousness for longer than a few seconds, rapid heart rate, difficulty breathing, muscle cramps, seizures, vomiting and diarrhea. If you or a loved one are showing signs of heat stroke, call 911 immediately or transport the person to the hospital. While waiting for help, keep the person in a cool environment, remove unnecessary clothing and apply ice packs or cool water to their skin. ### About Centre for Neuro Skills Centre for Neuro Skills (CNS) is an experienced and respected world leader that provides intensive rehabilitation and medical programs for those recovering from all types of brain injury. CNS covers a full spectrum of advanced acquired and traumatic brain injury rehabilitation care, from residential and assisted living programs to outpatient rehabilitation, day treatment and telehealth services. Founded by Dr. Mark Ashley in 1980, CNS has seven locations in California and Texas and has been recognized by the American Stroke Association for its work in stroke rehabilitation. For more information about Centre for Neuro Skills, visit: www.neuroskills.com, Instagram, Facebook, X (formerly known as Twitter), LinkedIn, and YouTube. Media, please note: To request an interview with CNS leadership or clinical staff, please contact Robin Carr at 415.766.0927 or CNS@landispr.com. Contact Details Landis Communications Inc. Robin Carr +1 415-766-0927 cns@landispr.com Company Website https://www.neuroskills.com/

July 23, 2024 08:01 AM Pacific Daylight Time

Classiq Transforms Quantum Computing with Qmod, The First High-Level Language for Quantum Programming

Classiq Technologies

Classiq today announced the general availability of Qmod (Quantum Modeling Language), the first high-level language (HLL) for quantum coding. Following successful pilot projects with enterprise partners, Qmod is now accessible to developers, researchers and enterprises worldwide and will transform quantum computing with its efficient, approachable method of programming. Qmod facilitates advanced quantum modeling and enables developers to describe quantum algorithms at a high level of abstraction. It supports unique quantum-computing concepts alongside conventional constructs found in high-level classical programming languages. This innovative approach allows developers to focus on the functional intent of their algorithms while Classiq’s powerful compiler and synthesis engine handle the intricate hardware-aware quantum implementation details. “To deliver a business or scientific value, quantum computing must be useful and accessible to scientists and engineers seeking to use quantum computing to solve real-world problems, which today it is not,” said Heather West, PhD, Research Manager, Quantum Computing at IDC. “Today, programming a quantum computer happens at the hardware level, making the technology only accessible to quantum physicists and other quantum specialists. As we begin to talk about quantum utility and near-term applications, abstraction-level application programming will become a necessity for wide-spread quantum adoption and usage.” Why The Qmod Language Is Different Declarative programming: Qmod’s declarative nature lets users define what their algorithm should achieve rather than how to achieve it; Classiq’s synthesis engine compiler optimizes for hardware and other constraints automatically. Flexibility and interoperability: Whether through native syntax, Python or graphical representation, Qmod descriptions are easily translatable and compatible across different formats and hardware. Industry-ready: Qmod is a tool for researchers and industry applications, providing robust scalable solutions for enterprise-grade quantum software development in an era of steadily growing qubit counts and the resulting coding complexity. “As we go further in building a complete quantum software stack, our groundbreaking Qmod language enables quantum experts to produce sophisticated programs while also allowing developers without a quantum background to innovate and solve complex problems across a variety of industry domains,” said Nir Minerbi, CEO and co-founder of Classiq. “By abstracting the complexities of quantum programming, Qmod delivers the ability to create and deploy dynamic quantum applications effortlessly. In some cases, it’ll use perhaps five lines of code instead of the traditional 100 lines of code. Like Java for the worldwide web or BASIC for PCs, Qmod is intended to open the gates to advanced quantum implementation.” Classiq’s platform ensures that quantum algorithms designed with Qmod can be seamlessly compiled for a broad range of hardware and simulation environments, as well as supporting seamless HPC integration. The platform's synthesis engine dynamically adapts implementations to different hardware configurations, allowing for rapid benchmarking and ensuring optimal implementations that make the very most of the available hardware. About Classiq Classiq Technologies, the leading quantum software company, provides an all-encompassing platform (IDE, compiler and OS) with a single point of entry into quantum computing, taking you from algorithm design to execution. The high-level descriptive quantum software development environment, tailored to all levels of developer proficiency, automates quantum programming. This ensures that a broad range of talents, including those with backgrounds in AI, ML and linear algebra, can harness quantum computing without requiring deep, specialized knowledge of quantum physics. Classiq democratizes access to quantum computing and equips its users to take full advantage of the quantum computing revolution, including access to a broad range of quantum hardware. Classiq’s core technology, algorithmic quantum circuit compilation, is engineered to power the quantum ecosystem of today and the future. Classiq works closely with quantum cloud providers and advanced computation hardware developers providing software for use with quantum computers, HPC, and quantum simulators. Backed by investors such as HPE, HSBC, Samsung, Intesa Sanpaolo and NTT, Classiq’s world-class team of scientists and engineers has distilled decades of quantum expertise into its groundbreaking quantum engine. Follow Classiq on LinkedIn, X (formerly Twitter) or YouTube, and visit the Slack community and https://www.classiq.io to learn more. Contact Details Rainier Communications Michelle Allard McMahon classiqPR@rainierco.com Company Website http://www.classiq.io/

July 23, 2024 08:00 AM Eastern Daylight Time

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Classiq and QuEra Announce Integration of Neutral-Atom Quantum Computers into Classiq Platform

Classiq Technologies

Classiq, the leader in quantum software development, and QuEra Computing, the leader in neutral-atom quantum computing, today announced a strategic collaboration to integrate QuEra’s cutting-edge neutral-atom quantum computers into the Classiq platform. This integration will enable customers to optimize a wide variety of quantum and hybrid quantum/classical algorithms for QuEra’s quantum computers, leveraging the unique capabilities of QuEra’s advanced quantum technology. With this collaboration, Classiq users will be able to exploit the distinctive features of QuEra’s neutral-atom quantum computers, such as the ability to simultaneously operate on multiple qubits and advanced qubit shuttling. Additionally, the integration provides access to Classiq’s extensive pre-written algorithmic blocks and allows customers to estimate the resources needed to run their algorithms. These capabilities enable the creation of highly resource-efficient algorithms with a large number of qubits and, in the future, for logical qubits as well. “Our partnership with QuEra represents a significant step forward in the quantum computing landscape,” said Nir Minerbi, CEO of Classiq. “By integrating QuEra’s neutral-atom technology into our platform, we are providing our users with unprecedented opportunities to enhance and optimize their quantum algorithms. This collaboration underscores our commitment to delivering the most versatile and powerful quantum computing solutions available.” “We are thrilled to collaborate with Classiq and bring the power of our neutral-atom quantum computers to a broader audience,” said Yuval Boger, Chief Commercial Officer of QuEra. “Classiq’s platform is renowned for its ease of use and flexibility, and by integrating our technology, we can help users unlock new potential and achieve groundbreaking results in their quantum computing projects.” The integration of QuEra’s quantum computers into the Classiq platform is expected to accelerate the development and deployment of quantum applications across various fields, including pharmaceuticals, finance, logistics and more. Customers who have purchased on-premises computers will be able to use the Classiq platform for the rapid development of quantum algorithms. This partnership highlights the ongoing commitment of both companies to drive innovation and make quantum computing more accessible and impactful. About Classiq Classiq Technologies, the leading quantum software company, provides an all-encompassing platform (IDE, compiler and OS) with a single point of entry into quantum computing, taking you from algorithm design to execution. The high-level descriptive quantum software development environment, tailored to all levels of developer proficiency, automates quantum programming. This ensures that a broad range of talents, including those with backgrounds in AI, ML and linear algebra, can harness quantum computing without requiring deep, specialized knowledge of quantum physics. Classiq democratizes access to quantum computing and equips its users to take full advantage of the quantum computing revolution, including access to a broad range of quantum hardware. Classiq’s core technology, algorithmic quantum circuit compilation, is engineered to power the quantum ecosystem of today and the future. Classiq works closely with quantum cloud providers and advanced computation hardware developers providing software for use with quantum computers, HPC, and quantum simulators. Backed by investors such as HPE, HSBC, Samsung, Intesa Sanpaolo and NTT, Classiq’s world-class team of scientists and engineers has distilled decades of quantum expertise into its groundbreaking quantum engine. Follow Classiq on LinkedIn, X (formerly Twitter) or YouTube, and visit the Slack community and https://www.classiq.io to learn more. About QuEra QuEra Computing is the leader in commercializing quantum computers using neutral atoms—widely recognized as a highly promising quantum modality. Based in Boston and built on pioneering research from nearby Harvard University and MIT, QuEra operates the world’s largest publicly accessible quantum computer, available over a major public cloud and for on-premises delivery. QuEra is developing large-scale, fault-tolerant quantum computers to tackle classically intractable problems, becoming the partner of choice in the quantum field. Simply put, QuEra is the best way to quantum. For more information, visit us at quera.com and follow us on X or LinkedIn. Contact Details Rainier Communications on behalf of Classiq Michelle Allard McMahon classiqPR@rainierco.com Merrill Freund on behalf of QuEra +1 415-577-8637 press@quera.com Company Website http://www.classiq.io/

July 23, 2024 08:00 AM Eastern Daylight Time

BestGrowthStocks.Com Issues Analysis on the Next Beneficiaries of the AI Revolution

SoundHound AI Inc.

NEW YORK, NY / NewsDirect / July 22nd, 2024 / Best Growth Stocks, a leading independent equity research and corporate access firm focused on finding and reporting on the best growth stocks utilizing exclusive ai-assisted research recently issued a comprehensive analysis of SoundHound AI, Inc. a pioneer in advanced voice-enabled AI and conversational intelligence technologies and a comprehensive analysis of the next beneficiaries of the AI revolution. SoundHound AI, Inc. (NASDAQ: SOUN) has garnered significant investor attention following multiple recent announcements that could prove to be significant catalysts for the AI company. Best Growth Stock's full report offers an analysis of SoundHound’s operations, potential upcoming catalysts, growth drivers, financials, share structure, chart, and more. Bonus content “The Next Beneficiaries of the AI Revolution” offers a comprehensive analysis of the next beneficiaries of the AI revolution, which ones stand to benefit near term, and stocks under $15/share to watch within each sector. Access this full analysis and bonus AI report with no obligation: https://bestgrowthstocks.com/soun-analysis/ Access this full analysis and bonus AI report with no obligation: https://bestgrowthstocks.com/soun-analysis/ About SoundHound AI SoundHound AI (Nasdaq: SOUN), a global leader in conversational intelligence, offers voice AI solutions that let businesses offer incredible conversational experiences to their customers. Built on proprietary technology, SoundHound’s voice AI delivers best-in-class speed and accuracy in numerous languages to product creators across automotive, TV, and IoT, and to customer service industries via groundbreaking AI-driven products like Smart Answering, Smart Ordering, and Dynamic Drive Thru, an AI-powered multimodal food ordering solution. Along with SoundHound Chat AI, a powerful voice assistant with integrated Generative AI, SoundHound powers millions of products and services, and processes billions of interactions each year for world class businesses. About Best Growth Stocks Best Growth Stocks is a leading independent equity research and corporate access firm focused on finding and reporting on the best growth stocks utilizing our exclusive ai-assisted research. BGS is also a financial news provider, focused on giving investors direct access to CEOs of promising, publicly-traded companies, and market experts. Our CEO interviews aim to answer the questions that rest on the minds of current and future shareholders. This is not to be construed as financial advice. Please consult with a licensed financial advisor before making any investment decisions. Media Contact Best Growth Stocks Senior Editor: Steve Macalbry Editor@BestGrowthStocks.com SOURCE: BestGrowthStocks.Com Contact Details Media Source LLC Steve Macalbry +1 989-274-7778 Editor@bestgrowthstocks.com

July 22, 2024 07:00 AM Eastern Daylight Time

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Tonix Pharmaceuticals Awarded potential 34 million dollar Contract with U.S. Department of Defence

Tonix Pharmaceuticals

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. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

July 19, 2024 12:48 PM Eastern Daylight Time

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LeadStar Marketplace Unleashes Groundbreaking Enhancements to Its Lead-Generation Platform

AmeriLife

LeadStar Marketplace, the proprietary, private leads platform created exclusively for AmeriLife -affiliated agents, announced today the launch of LeadStar 2.0, which features significant enhancements to its robust platform, designed to revolutionize how licensed insurance agents acquire quality leads for consumers seeking Medicare, Medicare Advantage, Affordable Care Act (ACA), and Final Expense (FE) insurance coverage. LeadStar 2.0 is available immediately to all existing customers. In collaboration with its customer base and affiliated health agencies, the LeadStar team has listened to what sales professionals value in today’s lead generation landscape, resulting in the upgraded LeadStar 2.0 platform. The platform’s enhanced approach to supplying leads features an extended lead catalog, multi-media channel capabilities, and advanced optimization technologies to set a new standard for lead generation efficiency and effectiveness. “At LeadStar, we are dedicated to pushing the boundaries of what's possible in lead generation,” said William DeCourcy, Chief Lead Generation Officer for AmeriLife. “These enhancements are a testament to our ongoing efforts to innovate and improve our services. We believe the new features will empower our clients to succeed even more in their marketing and sales endeavors.” The enhanced LeadStar 2.0 platform is designed to meet the demands of the evolving health and life insurance marketplace, ensuring licensed agents connect with the right prospects more efficiently than before. Extended Lead Catalog The extended lead catalog allows users to diversify and target a more comprehensive network of potential customers across various multimedia platforms and demographics. This expansion means agents can connect with the right prospects at the right time, which should dramatically increase conversion rates. LeadStar 2.0’s expansion targets social media, inbounds, direct mail, and transfers with real-time data across Medicare, MA, ACA, and FE. This deeper level of marketing funnel visibility offers more substantial visibility to each lead by understanding their customer journey before the sales process begins. Expanded Multimedia Channel Supply LeadStar 2.0 integrates a wealth of multi-media channel leads into its platform. Agents can now connect with potential customers through multiple touchpoints, including social media, email, and mobile, all within a unified system tailored to meet specific needs or strategies. This holistic approach streamlines the lead generation process, enhances user engagement and interaction, and aims to provide the lowest CPA possible. More Substantial Lead Delivery Moreover, LeadStar 2.0 introduces enhanced optimization capabilities to its platform. Advanced algorithms and machine learning power the platform and offer more intelligent lead matching and predictive lead scoring. These features ensure clients receive relevant and high-potential leads, reducing the time and effort they will spend on lead qualification and follow-up. For more information about LeadStar and the enhanced lead-generation platform, please email leadstar@leadstarhub.com or request access at LeadStarHub.com. ### About LeadStar LeadStar is an industry-leading enterprise leads program that delivers the compliant, reliable, and performative leads that today’s health and life insurance agents need to grow their books of business and maximize their success. Powered by AmeriLife and exclusively for the company’s affiliated agents, LeadStar’s suite of solutions includes LeadStar Marketplace, LeadStar Connect, and LeadStar Direct. For more information, contact an AmeriLife-affiliated marketing company or visit LeadStarHub.com. About AmeriLife AmeriLife’s strength is its mission: to provide insurance and retirement solutions to help people live longer, healthier lives. In doing so, AmeriLife has become recognized as the leader in developing, marketing, and distributing life and health insurance, annuities, and retirement planning solutions to enhance the lives of pre-retirees and retirees across the United States. For over 50 years, AmeriLife has partnered with top insurance carriers to provide value and quality to customers through a distribution network of over 300,000 insurance agents and advisors and 120 marketing organizations and insurance agency locations nationwide. For more information, visit AmeriLife.com and follow AmeriLife on Facebook and LinkedIn. Contact Details Media Jeff Maldonado Media@amerilife.com Company Website https://amerilife.com/

July 18, 2024 12:00 PM Eastern Daylight Time

News Release

ABVC BioPharma's CEO Discusses New Drug Development and AI Integration

ABVC BioPharma

After successfully completing Phase II clinical trials for their medication to treat Major Depressive Disorder, ABVC BioPharma Inc. and AiBtl BioPharma Inc. are now embarking on a groundbreaking clinical study focused on Depression in Cancer Patients. This new study will integrate AI-driven solutions to address the significant challenge of depression among cancer patients, a condition that often complicates treatment and adversely affects overall quality of life. Dr. Uttam Patil shared with Steve Darling from Proactive that the study aims to gain a deeper understanding of the prevalence and impact of depression in cancer patients. It will explore innovative therapeutic approaches by integrating real-time patient monitoring and enhanced patient analysis through an AI model. This advanced methodology is expected to increase the lead time for clinical trials, utilizing novel and sophisticated treatment protocols. The clinical study will be conducted at the renowned Cedars-Sinai Medical Center, involving cancer patients who experience depressive symptoms. By leveraging advanced AI technologies and employing cutting-edge diagnostic and therapeutic techniques, the study aims to monitor and treat depression in participants under meticulous medical supervision. Dr. Patil emphasized that the integration of AI-driven solutions in this clinical study represents a significant leap forward in the treatment of depression in cancer patients. The use of real-time patient monitoring and AI-based analysis is anticipated to provide valuable insights and improve patient outcomes, setting a new standard for clinical trials in this area. The collaboration between ABVC BioPharma and AiBtl BioPharma highlights their commitment to advancing healthcare through innovative solutions. This study is poised to make a substantial impact on the management of depression in cancer patients, offering hope for improved quality of life and better treatment outcomes. Through this pioneering study, ABVC BioPharma and AiBtl BioPharma are at the forefront of integrating technology with healthcare, paving the way for future advancements in the field. The companies are dedicated to utilizing AI to enhance patient care and accelerate the development of effective treatments for depression in cancer patients. Contact Details Proactive North America +1 604-688-8158 na-editorial@proactiveinvestors.com

July 18, 2024 10:31 AM Eastern Daylight Time

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Tonix Pharmaceuticals receives positive feedback from FDA on Tonmya™ for fibromyalgia management

Tonix Pharmaceuticals

Tonix Pharmaceuticals (NASDAQ:TNXP) 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 US 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. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

July 18, 2024 10:20 AM Eastern Daylight Time

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