Ready-to-use sepsis therapy marks new advancement in time-critical treatment 1 LONDON, Dec. 8, 2025 /PRNewswire/ -- Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, today announces the launch of the first-of-its-kind, ready-to-use vancomycin premix with room-temperature stability under the brand name TYZAVANâ"¢ (vancomycin injection, USP). TYZAVANâ"¢ is offered in pre-filled ready-to-use bags that will help hospitals, pharmacists, doctors, and nurses treat patients faster, more e ...

Core Insights - Spectral Medical Inc. reported significant progress in its Tigris trial, achieving positive topline results for its PMX treatment for endotoxic septic shock, with a 95.3% posterior probability of benefit for 28-day all-cause mortality and a 17.4% absolute mortality reduction for 90-day mortality [2][4][7] - The company is targeting a Premarket Approval (PMA) submission for Q1 2026, following ongoing discussions with the FDA to ensure a comprehensive submission [4][6][9] - Financial results for Q3 2025 showed a 34% increase in total revenue year-over-year, driven by higher product revenue, while operating expenses rose significantly due to non-cash adjustments related to derivative liabilities [9][11][15] Tigris Trial Results - The Tigris trial met its primary endpoint with a 95.3% posterior probability of benefit for 28-day all-cause mortality, and a >99% probability for 90-day mortality, indicating a clinically meaningful survival benefit [2][3][7] - The trial utilized Bayesian statistical methods, reinforcing the robustness of PMX as a life-saving therapy [3][4] Regulatory and Corporate Updates - The PMA submission is now targeted for Q1 2026, reflecting ongoing feedback from the FDA regarding non-clinical components [4][6][9] - The company is in discussions with the FDA to finalize the regulatory submission package, ensuring a high-quality and efficient review process [4][6] Financial Performance - Total revenue for Q3 2025 was $675,000, up from $502,000 in Q3 2024, marking a 34% increase [9][10] - For the nine months ended September 30, 2025, total revenue reached $2,060,000, a 26% increase from $1,641,000 in the same period of 2024 [9][10] - Operating expenses for Q3 2025 were $30.8 million, a 196% increase from $10.4 million in Q3 2024, primarily due to non-cash fair value adjustments [11][15][17] Cash Position and Financing - The company ended Q3 2025 with cash of $5.892 million, an increase from $2.988 million at the end of 2024 [19] - The balance sheet was strengthened by proceeds from warrant exercises and advances from Vantive, providing additional flexibility for regulatory and commercialization efforts [11][12][19] Market and Product Development - PMX is positioned as the first targeted therapy for endotoxic septic shock, with ongoing commercialization efforts in collaboration with Vantive [9][10][23] - The company aims to align its market readiness efforts with potential FDA approval timelines, enhancing its commercialization strategy [12][23]

Core Insights - CytoSorbents Corporation emphasizes the critical role of CytoSorb® therapy in treating sepsis and septic shock, showcasing new studies that indicate improved clinical outcomes when used early and intensively [1][2][12] - The company is hosting a World Sepsis Day Global Webinar on September 10, 2025, to discuss best practices and the impact of CytoSorb therapy in combating sepsis [1][12] Sepsis and Septic Shock Overview - Sepsis affects approximately 49 million people globally each year, resulting in 11 million deaths, which accounts for up to 20% of all global deaths [3] - Standard treatments for septic shock often fall short, with mortality rates ranging from 30% to 50%, especially in cases of multiple organ failure [4] CytoSorb Therapy - CytoSorb® is a first-in-class blood purification therapy approved in the EU, with nearly 300,000 treatments administered across over 70 countries [5][15] - The therapy utilizes advanced porous polymer beads to remove a variety of toxic substances from the bloodstream, including inflammatory cytokines and bacterial toxins [5][14] - CytoSorb's broad-spectrum approach addresses multiple aspects of sepsis, aiming to break the cycle of inflammation, restore blood flow, repair blood vessels, manage fluid overload, and prevent organ failure [6][11] Clinical Evidence - Clinical studies support the efficacy of early and intensive use of CytoSorb, with a 74% survival rate reported in a study of critically ill COVID-19 patients [8] - A retrospective study indicated that early and intensive CytoSorb use nearly doubled survival rates in septic shock patients [9] - A meta-analysis involving 744 patients demonstrated significant improvements in hemodynamics and survival rates when CytoSorb was used alongside standard care [10] Company Mission and Future Directions - CytoSorbents aims to improve treatment outcomes for sepsis and septic shock, guided by clinical insights and a growing body of evidence [12] - The company is actively engaged in regulatory processes for its DrugSorb™-ATR system in the U.S. and Canada, which aims to reduce perioperative bleeding [16][17]