Group 1 - Tonix Pharmaceuticals presented promising preclinical data for its investigational mpox and smallpox vaccine candidate, TNX-801, at the World Vaccine Congress Europe 2025 [1][2] - The TNX-801 vaccine demonstrated strong immune responses, long-term protection for at least 14 months, and favorable safety across multiple animal models [2] - The company is pursuing a Phase I clinical trial in collaboration with the Kenya Medical Research Institute and is exploring microneedle patch technology for vaccine administration [2] Group 2 - Tonix Pharmaceuticals is currently unprofitable, with analysts not expecting profitability this year [2] - The company focuses on developing therapies and vaccines for central nervous system disorders, immunology, infectious diseases, and rare diseases [2] - Tonix also markets existing products for the treatment of acute migraine headaches, such as Zembrace SymTouch and Tosymra [2]

Company Overview - Tonix Pharmaceuticals Holding Corp. is a fully-integrated commercial biopharmaceutical company with marketed products and a pipeline of development candidates [3] - The company has received FDA approval for Tonmya™, a first-in-class, non-opioid analgesic for the treatment of fibromyalgia, marking the first approval for a new prescription medicine for this condition in over 15 years [3] - Tonix also markets two treatments for acute migraine in adults and focuses on central nervous system disorders, immunology, immuno-oncology, rare diseases, and infectious diseases [3] Pipeline and Development - The company’s development portfolio includes TNX-102 SL for acute stress reaction and major depressive disorder, funded by the U.S. Department of Defense [3] - Tonix's immunology portfolio features TNX-1500, a monoclonal antibody for preventing organ transplant rejection and treating autoimmune diseases [3] - The rare disease portfolio includes TNX-2900 for Prader-Willi syndrome, while the infectious disease portfolio includes TNX-801 for mpox and smallpox, and TNX-4800 for Lyme Disease prevention [3] - TNX-4200 is a broad-spectrum antiviral agent with a contract from the U.S. DoD for up to $34 million over five years [3] Upcoming Events - Seth Lederman, M.D., CEO of Tonix Pharmaceuticals, will present at BIO-Europe 2025 on November 4, 2025, highlighting the company's strategy and pipeline [1][2]

Group 1 - U.S. stock futures showed mixed results, with S&P 500 futures declining approximately 0.1% [1] - Fabrinet reported better-than-expected fourth-quarter financial results for fiscal 2025, with expected first-quarter revenue between $910 million and $950 million, slightly below estimates of $916.72 million [2] - Fabrinet's expected first-quarter adjusted earnings are projected to be between $2.75 and $2.90 per share, slightly above the estimate of $2.74 per share [2] Group 2 - Fabrinet shares fell 9.7% to $295.54 in pre-market trading following the earnings report [2] - Xunlei Limited experienced a decline of 8.4% to $8.05 in pre-market trading after a significant increase of around 38% on the previous day [4] - Precigen, Inc. shares dipped 5.8% to $2.78 in pre-market trading after the FDA approved PAPZIMEOS [4] - Adecoagro S.A. shares fell 4.5% to $8.79 in pre-market trading after reporting disappointing quarterly results [4] - Immatics NV shares decreased by 3.9% to $5.97 in pre-market trading [4] - Tonix Pharmaceuticals Holding Corp shares fell 3.9% to $38.51 in pre-market trading following FDA approval of Tonmya for fibromyalgia in adults [4]

Group 1 - The core point of the article is that Tonix Pharmaceuticals (TNXP.US) experienced a pre-market increase of over 10% following the FDA's approval of its drug for treating chronic pain-related symptoms [1] Group 2 - The FDA approval is a significant milestone for Tonix, potentially enhancing its market position in the biopharmaceutical industry [1]

Group 1 - U.S. stock futures are lower, with Dow futures dropping over 250 points [1] - Oxford Industries reported adjusted EPS of $1.82, meeting estimates, and quarterly sales of $392.86 million, exceeding expectations of $384.77 million [2] - Oxford Industries shares fell 10.1% to $44.99 in pre-market trading after issuing second-quarter earnings guidance below estimates and lowering FY25 guidance [2] Group 2 - Tonix Pharmaceuticals Holding Corp. shares dipped 17% to $31.32 as the company may sell up to $150 million in common stock [5] - GameStop Corp. shares fell 12.4% to $24.97 following the announcement of a $1.75 billion proposed private offering of convertible senior notes [5] - The Boeing Company shares decreased 7.4% to $198.10 after an Air India Boeing 787-8 Dreamliner crashed near Ahmedabad airport [5]

Core Insights - Tonix Pharmaceuticals will present at the World Vaccine Congress Washington 2025, focusing on a novel mpox vaccine and leading a panel discussion on vaccine development and biosecurity policy [1][2][3] Company Overview - Tonix Pharmaceuticals is a fully integrated biopharmaceutical company with a focus on pain management therapies and vaccines for public health challenges [4] - The company is advancing TNX-102 SL for fibromyalgia management, with a PDUFA goal date of August 15, 2025, and has received Fast Track designation from the FDA [4] - Tonix's CNS portfolio includes TNX-1300 for cocaine intoxication, which has FDA Breakthrough Therapy designation, and TNX-1500 for organ transplant rejection and autoimmune diseases [4] - The infectious disease portfolio includes TNX-801, a vaccine for mpox and smallpox, and TNX-4200, a broad-spectrum antiviral agent with a contract worth up to $34 million with the U.S. DoD [4] Upcoming Events - The oral presentation will be led by Dr. Farooq Nasar on April 23, 2025, at 10:10 a.m., discussing a single-dose mpox vaccine [2] - A panel discussion moderated by Dr. Zeil Rosenberg will take place on the same day at 3:25 p.m., addressing mpox and smallpox threats [3]

Core Viewpoint - The collaboration between Tonix Pharmaceuticals and Makana Therapeutics aims to utilize Tonix's TNX-1500 monoclonal antibody in conjunction with Makana's genetically engineered pig organs to enhance organ compatibility and reduce rejection in xenotransplantation [1][2]. Group 1: Collaboration Details - Tonix and Makana have established a research agreement to study TNX-1500 in combination with Makana's human-compatible organs for organ failure treatment [1]. - The collaboration will support preclinical studies for kidney, heart, and islet cell transplant programs, aiming for regulatory filings for potential human use [1][2]. - The goal is to submit an investigational new drug application (IND) to the FDA for compassionate use in patients undergoing xenotransplantation [1]. Group 2: Product and Technology Insights - TNX-1500 is an investigational humanized monoclonal antibody targeting CD40L, which plays a crucial role in immune system activation and transplant immunomodulation [2][8]. - Makana's genetically engineered pigs, particularly the SLA DR knockout pig, have shown improved compatibility and potential for producing viable organs for transplantation [2][3][4]. - The collaboration aims to leverage the best-in-class pharmacokinetics and pharmacodynamics of TNX-1500, which has demonstrated effectiveness in preventing rejection in animal studies [2][7]. Group 3: Industry Context - The field of xenotransplantation faces challenges in organ compatibility and rejection, making this collaboration significant for advancing clinical applications [2][5]. - Makana's focus on antigen discovery and deletion, rather than relying on transgenic modifications, positions it favorably for future commercialization of xenotransplantation products [6][5]. - The partnership is expected to streamline the development of safer and more effective transplantation solutions, addressing the critical shortage of available human organs [2][4].

CHATHAM, N.J., April 02, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that Seth Lederman M.D., Chief Executive Officer of Tonix Pharmaceuticals, will present at the 2025 Jones Trading Healthcare and Innovation Conference on Wednesday, April, 9, 2025, at 10:00 a.m. PT (1:00 p.m. ET) in Las Vegas, Nev. Investors interested in arranging a meeting with the ...

CHATHAM, N.J., April 01, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with a portfolio of marketed products and a pipeline of development candidates, today announced the launch of TONIX ONE™, a fully-integrated digital platform designed to help patients better understand and manage their migraine condition. Through a series of strategic partnerships with UpScript Telemedicine, ProModRx, Blink Health and a leading mobile application specializing in ...

Core Viewpoint - Tonix Pharmaceuticals has launched TONIX ONE™, a digital platform aimed at improving the management of migraine conditions for patients through strategic partnerships and integrated services [1][2][4]. Group 1: Product Launch and Features - TONIX ONE™ is designed to provide a comprehensive digital solution that guides patients from tracking their migraine symptoms to prescription fulfillment within hours [2][3]. - The platform offers educational resources about migraines and connects patients with specialists via telehealth services, enhancing access to treatment [3][4]. - The integration of services from partners like UpScript Telemedicine and Blink Health aims to streamline the patient journey and improve overall care [1][5][6]. Group 2: Company Positioning and Strategy - The launch of TONIX ONE™ reinforces Tonix Pharmaceuticals' position as an innovator in the biopharmaceutical industry, addressing inefficiencies in migraine treatment [4]. - The platform not only enhances patient access to medications but also creates value across Tonix's existing product portfolio and future business development opportunities [4][8]. - Tonix Pharmaceuticals is focused on transforming therapies for pain management and CNS disorders, with a development pipeline that includes products for fibromyalgia and other conditions [8][9]. Group 3: Partnerships and Technology - ProModRx offers a digital solution for e-prescription requests, while UpScript provides access to a network of migraine clinicians for patients without established care [5]. - Blink Health utilizes advanced technology to improve patient access to branded medications, further supporting the goals of TONIX ONE™ [6]. - A third-party mobile application integrated into the platform empowers patients with data-driven insights for better self-management of their migraine symptoms [7].