Ra’anana, Israel, Dec. 11, 2025 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (Nasdaq: PLRZ) (“Polyrizon” or the “Company”), a biotechnology company focusing on the development of intranasal products, today announced new results from its ongoing preclinical evaluation of its proprietary intranasal naloxone hydrogel formulation, demonstrating promising permeation kinetics that complement the Company’s previously reported stability and mucoadhesion successes. Following the positive mucoadhesion findings-where Polyrizon’ ...

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]

Core Insights - Several companies have shown significant price movements, attracting investor attention, including Aclarion, Inc., Aeva Technologies, Polyrizon Ltd., SMX, and Synchronoss Technologies [1] Company Summaries - **Aclarion, Inc. (NASDAQ:ACONW)**: The stock price surged to $0.11, reflecting a 184.97% increase, driven by a trading volume of 369,174, focusing on healthcare technology solutions for degenerative pain biomarkers [2][7] - **Polyrizon Ltd. (NASDAQ:PLRZ)**: The stock price rose to $13.95, marking a 96.76% gain, with a trading volume of 23,290,576, attributed to its innovative nasal sprays aimed at blocking viruses and allergens, and a pivotal manufacturing milestone [3][7] - **SMX (Security Matters) Public Limited Company (NASDAQ:SMX)**: The stock price increased to $102.45, a 75.16% rise, with a trading volume of 3,851,727, reflecting market confidence in its proprietary marker system and blockchain technology for brand protection [4][7] - **Synchronoss Technologies, Inc. (NASDAQ:SNCR)**: The stock price climbed to $8.71, a 64.34% increase, with a trading volume of 1,740,890, following a definitive acquisition agreement by Lumine Group for approximately $116.4 million, enhancing its portfolio in communications and media software [5][7] Market Environment - The recent price movements indicate a dynamic market environment where technological advancements and innovative solutions are crucial in driving investor interest and stock performance [6]

Core Insights - Polyrizon Ltd. is advancing its development of non-pharmacological solutions for respiratory defense, particularly through its innovative hydrogel-based nasal spray technology [1][4][8] Company Overview - Founded by Tomer Izraeli, Polyrizon focuses on creating smarter nasal protection to address gaps in traditional nasal sprays, which often provide only temporary relief [2][4] - The company's proprietary Capture & Contain™ (C&C) platform utilizes a bio-adhesive hydrogel to form a protective barrier in the nasal cavity, effectively trapping airborne particles [2][4] Product Development - Polyrizon's flagship product, PL-14 Allergy Blocker, is designed to provide drug-free protection against allergens by forming a moisturizing barrier in the nasal cavity [3][4] - The company has achieved significant manufacturing milestones, successfully producing larger-scale batches of PL-14 under controlled conditions, confirming its ability to scale for clinical trials and future commercial production [5][6] Market Potential - The seasonal allergic rhinitis market is projected to grow from USD 11.14 billion in 2025 to USD 13.79 billion by 2032, with a CAGR of 3.1% [4] - The global influenza market is expected to grow at a CAGR of 7.2%, reaching USD 12.8 billion by 2029, indicating a strong demand for innovative respiratory solutions [4] Future Directions - Polyrizon aims to expand the applications of its C&C platform beyond allergies to include viral protection against respiratory pathogens [7] - The company is also developing its Trap & Target™ (T&T) technology for targeted delivery of active pharmaceutical ingredients, which could address various medical conditions [7][8]

Core Insights - Polyrizon Ltd. has announced new preclinical data indicating that its proprietary naloxone hydrogel demonstrates superior mucoadhesion compared to an existing intranasal naloxone spray product, which may enhance opioid overdose reversal in real-world emergencies [1][5]. Group 1: Product Performance - The study utilized an ex-vivo rabbit nasal mucosa model to compare the persistence of Polyrizon's hydrogel formulation against a commercial product, revealing that Polyrizon's hydrogel maintained significantly higher levels of a fluorescence marker, indicating stronger and more durable mucosal retention (p < 0.0001) [2]. - Polyrizon's Trap and Target ™ (T&T) hydrogel exhibited significantly higher mucoadhesion levels, suggesting prolonged contact at the nasal deposition site and potentially improved bioavailability [3]. Group 2: Importance of Mucoadhesion - Enhanced mucoadhesion is critical for intranasal drug delivery, especially for emergency treatments like opioid overdose reversal, as it supports more reliable absorption and potentially faster onset of action [4]. Group 3: Company Perspective - The CEO of Polyrizon emphasized that the results validate the potential of the T&T hydrogel platform and highlight its advantages in intranasal drug delivery, marking an important milestone in advancing the Naloxone program [5]. - The new dataset builds on previously reported stability results, reinforcing the robustness of Polyrizon's formulation under various storage conditions, which collectively supports the potential for a safer and more effective intranasal naloxone product [5]. Group 4: Company Overview - Polyrizon is a development-stage biotech company focused on innovative medical device hydrogels delivered as nasal sprays, which create a barrier against viruses and allergens while also enhancing drug delivery through improved bioadhesion and retention [6].

Group 1: YieldMax ETFs - YieldMax AI Option Income Strategy ETF (NYSE:AIYY) surged to $19.23, an increase of $17.33 or 912.37%, driven by its income-generating strategy and exposure to C3 ai, Inc. stock [1][7] - YieldMax Short TSLA Option Income Strategy ETF (NYSE:CRSH) rose to $28.17, up by $25.39 or 913.31%, attributed to investor interest in income strategies and speculative movements regarding Tesla's stock performance [2][7] - YieldMax Short COIN Option Income Strategy ETF (NYSE:FIAT) experienced a price increase to $25.91, with a change of $23.25 or 874.06%, reflecting growing interest in cryptocurrency-related financial products [3] Group 2: Polyrizon Ltd. - Polyrizon Ltd. (Nasdaq:PLRZ) saw its price increase to $7.52, up by $4.36 or 137.98%, driven by its development of nasal sprays as barriers against viruses and allergens [4][7] - The successful completion of a significant manufacturing upscaling milestone for Polyrizon's nasal spray platform is crucial for advancing clinical and regulatory activities [4] Group 3: Eventbrite, Inc. - Eventbrite, Inc. (NYSE:EB) experienced a price rise to $4.43, marking an increase of $1.95 or 78.83%, benefiting from the resurgence of live events post-pandemic [5] - An investigation into possible breaches of fiduciary duty related to Eventbrite's recent transaction could impact investor sentiment [5] Group 4: Market Trends - Significant price movements in these companies are attributed to innovative income-generating strategies, investor interest in specific sectors, and broader market trends [6] - The developments highlight diverse opportunities and risks present in the current financial market landscape [6]

Core Insights - Polyrizon Ltd. has successfully completed a significant manufacturing upscaling milestone for its proprietary nasal-spray product platform, which is crucial for future clinical and regulatory activities as well as potential commercial readiness [1][2] Manufacturing Upscaling - The company transitioned from small-batch laboratory production to larger-scale, controlled manufacturing to validate key parameters of the PL-14 formulation, demonstrating reliable production at increased batch volumes while maintaining high-quality specifications [2] - This manufacturing process will support the clinical trial material (CTM) needed for upcoming clinical trials expected to commence in 2026, adhering to USA and European regulatory standards [2] Product Overview - PL-14 is an innovative intranasal protective spray designed to create a fast-acting, moisturizing barrier in the nasal cavity, which helps trap, isolate, and neutralize airborne allergens before they reach the mucosa [3] - The product is based on a proprietary bio-adhesive formulation developed by Polyrizon's R&D team, aimed at providing extended protection and offering a non-pharmacological solution for allergy sufferers in high allergen environments [3] Company Background - Polyrizon specializes in developing innovative medical device hydrogels delivered as nasal sprays, forming a hydrogel-based shield that acts as a barrier against viruses and allergens [4] - The company's proprietary Capture and Contain (C&C) hydrogel technology is designed to function as a "biological mask," and it is also developing additional technology for nasal delivery of active pharmaceutical ingredients, referred to as Trap and Target (T&T) [4]

Core Viewpoint - Polyrizon Ltd. has announced positive in-vitro results for its PL-16 Viral Blocker, demonstrating strong protection against H1N1 influenza through a reversible physical barrier mechanism [1][4]. Group 1: Product Efficacy - The PL-16 formulation effectively blocked infection from multiple respiratory viruses, including H1N1, maintaining high cell viability and preventing viral-induced cytopathic effects [2][4]. - The formulation exhibited robust protection without cytotoxicity, confirming both safety and efficacy [2][4]. Group 2: Mechanism of Action - The antiviral effect is due to a reversible physical interaction rather than irreversible viral inactivation, as viruses regained infectivity after the formulation was removed [3][4]. - The formulation acts as a temporary physical barrier that prevents viral particles from entering host cells [3][4]. Group 3: Future Development - Polyrizon plans to advance the PL-16 formulation through clinical studies, subject to regulatory approvals, reinforcing its commitment to innovative respiratory protection solutions [4][5]. - The company is also developing additional aspects of its Capture and Contain hydrogel technology for enhanced nasal delivery of drugs [6].

Core Insights - Polyrizon Ltd. announced positive results from a pre-clinical study of its PL-14 Allergy Blocker formulation, demonstrating its effectiveness in blocking allergens, specifically the Der p 1 allergen from house dust mites [1][2][5] Company Overview - Polyrizon is a biotechnology company focused on developing intranasal products using its proprietary Capture & Contain (C&C) platform, which creates a hydrogel barrier to protect against allergens and viruses [6] Study Results - The pre-clinical study showed that PL-14 significantly limited allergen diffusion, with only 1.07% of the allergen penetrating after one hour, 1.14% after two hours, and 13.6% after four hours [8] - The allergen load used in the study was significantly higher than typical exposure levels, suggesting that PL-14 may provide strong protection even in extreme conditions [3] Market Potential - The Allergy Immunotherapy market is projected to grow from USD 1.9 billion in 2025 to USD 4.2 billion by 2035, with a CAGR of 7.9%, driven by the rising prevalence of allergies and advancements in treatment methodologies [4] Future Plans - Polyrizon plans to advance its preclinical development program and initiate clinical studies to support regulatory pathways for PL-14 and other candidates within the C&C platform [5][9]