Core Insights - Polyrizon Ltd. has initiated a key usability study for its lead product candidate, NASARIX™, aimed at confirming alignment with FDA requirements and supporting clinical development [1][2] Group 1: Product Development - NASARIX™ is an innovative intranasal allergy blocker designed for broad consumer use, representing a significant advancement in Polyrizon's development roadmap [1][2] - The usability study is intended to de-risk downstream regulatory review and facilitate a streamlined path toward clinical trials [2][3] Group 2: Regulatory Milestones - Successful completion of the usability program will provide essential regulatory evidence for NASARIX™'s readiness for clinical evaluation, with trials expected to commence in Q3 2026 [3][4] - The study underscores the company's commitment to FDA-aligned development, patient safety, and user-centered solutions [4] Group 3: Company Overview - Polyrizon specializes in developing innovative medical device hydrogels delivered as nasal sprays, which create a barrier against viruses and allergens [4] - The proprietary Capture and Contain™ hydrogel technology aims to function as a "biological mask" in the nasal cavity, with ongoing development focused on enhancing bioadhesion and retention [4]

Core Insights - Polyrizon Ltd. is committed to advancing its core intranasal medical pipeline while exploring strategic investment opportunities in sectors such as aviation, AI, and defense [1][2][3] - The company is focusing on high-potential sectors for initial investment efforts, while continuing to develop its medical devices, including products like PL-14 and PL-16 [2][3] - Polyrizon's Board of Directors has approved selective investments aimed at generating near-term revenues and enhancing financial stability, leveraging the company's strong cash position and debt-free balance sheet [3] Company Overview - Polyrizon is a development-stage biotech company specializing in innovative medical device hydrogels delivered as nasal sprays, which create a barrier against viruses and allergens [4] - The proprietary Capture and Contain TM hydrogel technology is designed to function as a "biological mask" in the nasal cavity, with ongoing development to improve bioadhesion and drug delivery [4]

As part of the branding process, Polyrizon conducted comprehensive trademark screening across the U.S. and European markets Raanana, Israel, Jan. 08, 2026 (GLOBE NEWSWIRE) -- Polyrizon Ltd. Polyrizon Ltd. (Nasdaq: PLRZ) (“Polyrizon” or the “Company”), a pre-clinical-stage biotechnology company developing intranasal protective solutions, today announced that it has completed the branding process for its PL-14 allergy blocker, which will be marketed under the brand name NASARIX™. NASARIX™ is based on Polyriz ...

Core Insights - Polyrizon Ltd. announced positive results from a pre-clinical study evaluating its PL-14 Allergy Blocker formulation, demonstrating its effectiveness in blocking allergens compared to hydroxypropyl methylcellulose (HPMC) [1][5]. Study Findings - The study utilized a validated in-vitro Transwell permeability system to assess PL-14's ability to inhibit the transfer of Der p 1, a significant house dust mite allergen associated with allergic rhinitis and asthma [2]. - PL-14 significantly reduced allergen transfer at all time points compared to HPMC, with statistical significance (p-values ≤ 0.0042) observed at 1, 2, 4, 6, and 24 hours [3][9]. - At 1 hour, PL-14 showed a mean allergen concentration of approximately 20.6 ng, while HPMC had a concentration of about 1354.4 ng. By 24 hours, HPMC's concentration rose to around 5201.2 ng, indicating limited barrier function [9]. Product Development - The results support the continued advancement of PL-14 as a preventive approach for allergic rhinitis by reducing allergen penetration through a synthetic surface [6]. - Polyrizon is advancing its preclinical development program and plans to support future clinical studies to establish PL-14's regulatory pathway and clinical benefits for allergy prevention [6]. Company Overview - Polyrizon is a development-stage biotechnology company focused on innovative medical device hydrogels delivered as nasal sprays, creating a barrier against viruses and allergens [7]. - The company's proprietary Capture and Contain TM hydrogel technology aims to function as a "biological mask" in the nasal cavity, with ongoing development to enhance bioadhesion and retention for drug delivery [7].

Raanana, Israel, Jan. 02, 2026 (GLOBE NEWSWIRE) -- As the 2025-2026 flu season intensifies across the United States, a mutated strain of influenza A is driving most cases, sparking concerns about a potentially tough winter ahead. According to the latest CDC estimates (as of late December 2025), flu has already caused at least 4.6 million illnesses, 49,000 hospitalizations, and 1,900 deaths nationwide. Flu activity is rising sharply, with outpatient visits for influenza-like illness well above baseline in ma ...

Core Viewpoint - Polyrizon Ltd. is advancing its core medical pipeline while exploring investment opportunities in revenue-generating assets to enhance shareholder value [1][3]. Product Development - The company is committed to its core medical device activities, focusing on the development of products such as PL-14 (allergy blocker), PL-16 (viral blocker), and the Trap & Target platform for intranasal drug delivery [2][3]. Strategic Initiatives - The Board of Directors has authorized the exploration of investments in assets expected to generate revenues, aiming to utilize the company's resources efficiently for growth and long-term shareholder value [3]. Technology Overview - Polyrizon specializes in innovative medical device hydrogels delivered as nasal sprays, which create a barrier against viruses and allergens in the nasal cavity [4]. - The proprietary Capture and Contain TM hydrogel technology is designed to function as a "biological mask" and is being further developed for enhanced bioadhesion and drug delivery [4].

Core Insights - Polyrizon Ltd. has submitted a Pre-Request for Designation (Pre-RFD) to the FDA for its PL-16 Viral Blocker, which has shown over 90% efficacy in protecting cells against viruses [1][2][7] - The PL-16 product is designed to create a physical barrier in the nasal cavity to reduce exposure to airborne respiratory viruses, addressing a significant public health challenge during the flu season [3][4][8] Product Overview - PL-16 is a metered-dose intranasal spray that forms a muco-adhesive hydrogel layer, mechanically reducing contact between airborne particles and the nasal epithelium [4][10] - The product is intended for local use only, with no systemic exposure or pharmacological activity [4] Supporting Evidence - The Pre-RFD submission is backed by in-vitro studies demonstrating that PL-16 preserves cell viability against influenza A and human coronavirus by preventing viral access [7] - Studies confirm that PL-16 acts purely as a mechanical barrier, with viruses remaining infective after being recovered from the hydrogel [7] Market Opportunity - The global nasal spray market was valued at USD 29.83 billion in 2024 and is projected to grow to USD 58.90 billion by 2032, with a CAGR of 8.9% [6] - Seasonal respiratory infections represent a recurring global market with significant economic impact due to lost productivity [6][8] Strategic Context - The PL-16 program is part of Polyrizon's broader strategy to develop non-medicated intranasal solutions, building on its Capture and Contain technology platform [5] - The company aims to address multiple respiratory indications through scalable, drug-free nasal technologies [5] Next Steps - Following feedback from the FDA on the Pre-RFD, Polyrizon will align on the next development steps for PL-16 and continue advancing its intranasal platform [9]

Core Insights - Polyrizon Ltd. has announced promising results from its preclinical evaluation of an intranasal naloxone hydrogel formulation, highlighting its potential for improved drug delivery in emergency situations [1][4]. Group 1: Product Development - The company has demonstrated significantly enhanced mucoadhesion of its formulation on ex-vivo nasal tissue compared to a marketed product, with a p-value of less than 0.0001 [2]. - Permeation studies indicate that despite improved mucoadhesion, the hydrogel maintains rapid permeation kinetics comparable to existing naloxone products, ensuring fast action in emergencies [3][8]. - The results from stability, mucoadhesion, and permeability studies collectively position Polyrizon's naloxone hydrogel for further development stages [8]. Group 2: Market Context - The opioid crisis is escalating, with over 80,000 deaths annually in the U.S. due to opioid overdoses, necessitating improved naloxone delivery systems [5]. - The global naloxone market is projected to reach several billion dollars in the coming years, driven by public health initiatives and regulatory support for innovative products [5]. - Intranasal formulations are preferred for their ease of use and rapid action, making technologies like Polyrizon's hydrogel critical for enhancing treatment reliability during overdose events [5]. Group 3: Company Overview - Polyrizon specializes in developing innovative medical device hydrogels for intranasal delivery, aiming to create a barrier against viruses and allergens while enhancing drug retention [6]. - The company's proprietary technologies include Capture and Contain™ and Trap and Target™, focusing on improving bioadhesion and prolonged retention for drug delivery [6].

Core Viewpoint - Polyrizon Ltd. has successfully completed a pre-submission meeting with the FDA for its PL-14 Allergy Blocker product, marking a significant milestone in its development process [1][5]. Company Overview - Polyrizon is a biotechnology company focused on developing intranasal products, specifically nasal sprays that create a protective barrier against allergens and viruses [7]. - The company's proprietary technology, Capture and Contain TM (C&C), utilizes naturally occurring building blocks to form a hydrogel-based shield in the nasal cavity [7]. Development Program - During the FDA meeting, Polyrizon presented its development program for PL-14, including the manufacturing process, quality controls, and stability program [2]. - The company discussed its biocompatibility assessment and preclinical studies in line with FDA guidelines for nasal spray products [2]. Clinical Development Strategy - Polyrizon outlined its clinical development strategy for PL-14, with clinical trials expected to begin in 2026, detailing study designs and endpoints to evaluate safety and performance [3]. Market Potential - The global allergen blocker market is projected to reach USD 210 million by 2033, driven by the increasing incidence of allergies and demand for allergy relief products [4]. Regulatory Alignment - The pre-submission meeting with the FDA is seen as a crucial step for Polyrizon, providing early regulatory alignment and clarity on requirements, which may facilitate efficient advancement of the PL-14 program [5][6].

Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential trading opportunities before the market opens [1] Premarket Gainers - Cemtrex, Inc. (CETX) has increased by 284% to $11.79 - Treasure Global Inc. (TGL) has risen by 135% to $59.83 - Top Wealth Group Holding Limited (TWG) is up 95% at $11.73 - Fulcrum Therapeutics, Inc. (FULC) has gained 49% to $13.29 - MetaVia Inc. (MTVA) is up 33% at $10.90 - Kymera Therapeutics, Inc. (KYMR) has increased by 31% to $87.58 - Confluent, Inc. (CFLT) is up 27% at $29.40 - Immix Biopharma, Inc. (IMMX) has risen by 23% to $6.85 - Nurix Therapeutics, Inc. (NRIX) is up 18% at $21.46 - SU Group Holdings Limited (SUGP) has increased by 15% to $6.44 [3] Premarket Losers - SMX (Security Matters) Public Limited Company (SMX) has decreased by 27% to $242.01 - Meihua International Medical Technologies Co., Ltd. (MHUA) is down 27% at $10.20 - Polyrizon Ltd. (PLRZ) has declined by 16% to $10.90 - Fly-E Group, Inc. (FLYE) is down 16% at $6.90 - Sensei Biotherapeutics, Inc. (SNSE) has decreased by 14% to $8.29 - Kentucky First Federal Bancorp (KFFB) is down 10% at $4.00 - Arteris, Inc. (AIP) has declined by 7% to $16.27 - Fusion Fuel Green PLC (HTOO) is down 6% at $3.89 - Kamada Ltd. (KMDA) has decreased by 5% to $6.69 - iOThree Limited (IOTR) is down 5% at $3.11 [4]