Polyrizon Ltd.
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Polyrizon to Explore Revenue-Generating Real Asset Opportunities, Leveraging Strong Cash Position and Debt-Free Balance Sheet
Globenewswire· 2025-12-29 12:20
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].
Polyrizon Submits Pre-Request for Designation to FDA for PL-16 Viral Blocker Designed to Reduce the Exposure to Influenza and Cold Viruses
Globenewswire· 2025-12-19 13:20
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]
Polyrizon Announces Promising Permeation Kinetics Supporting Advancement of Its Intranasal Naloxone Hydrogel Program
Globenewswire· 2025-12-11 13:15
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].
Polyrizon Completes FDA Pre-Submission Meeting for PL-14 Allergy Blocker Nasal Spray
Globenewswire· 2025-12-08 13:55
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].
Crude Oil Gains Over 1%; Kroger Shares Slide After Q3 Results
Benzinga· 2025-12-04 17:15
Market Overview - U.S. stocks showed mixed performance with the Nasdaq Composite gaining approximately 0.2% while the Dow decreased by 0.04% [1] - Industrials sector saw a rise of 0.7% on Thursday, contrasting with a 1.2% decline in consumer staples stocks on Wednesday [1] Company Performance - Kroger Company (NYSE:KR) experienced a stock decline of around 6% following mixed quarterly results, with adjusted earnings per share of $1.05 surpassing the analyst consensus of $1.03, but quarterly sales of $33.859 billion fell short of the expected $34.155 billion [2] Commodity Market - Oil prices increased by 1.5% to $59.85, while gold rose by 0.2% to $4,241.30; however, silver and copper saw declines of 2% to $57.475 and 0.5% to $5.3650, respectively [5] International Markets - European shares were generally higher, with the eurozone's STOXX 600 rising by 0.45% and Spain's IBEX 35 Index increasing by 0.97% [6] - Asian markets closed mostly higher, highlighted by Japan's Nikkei gaining 2.33% and Hong Kong's Hang Seng rising by 0.68% [7] Notable Stock Movements - Polyrizon Ltd. (NASDAQ:PLRZ) shares surged by 92% to $13.59 following positive preclinical test data [8] - Science Applications International Corp (NASDAQ:SAIC) saw an 18% increase to $103.34 after raising FY2026 EPS and sales guidance [8] - UiPath Inc (NYSE:PATH) shares rose by 22% to $18.08 after reporting better-than-expected third-quarter results [8] - Genesco Inc. (NYSE:GCO) shares fell by 30% to $24.69 due to worse-than-expected third-quarter results and lowered FY26 guidance [8] - Cross Country Healthcare, Inc. (NASDAQ:CCRN) shares dropped by 19% to $7.65 after terminating a merger agreement [8] - Nauticus Robotics, Inc. (NASDAQ:KITT) shares decreased by 17% to $1.29 following announcements regarding exchange agreements [8] Economic Indicators - U.S. initial jobless claims decreased by 27,000 to 191,000 in the last week of November [11] - Job cuts announced by U.S.-based employers rose to 71,321 in November, up from 57,727 in the previous year [11] - New orders for U.S. manufactured goods increased by 0.2% month-over-month in September [11] - U.S. natural-gas stocks declined by 12 billion cubic feet during the week ending November 28 [11]
US Stocks Edge Higher; Dollar General Shares Jump After Upbeat Earnings - Cross Country Healthcare (NASDAQ:CCRN), Able View Global (NASDAQ:ABLV)
Benzinga· 2025-12-04 14:56
Market Overview - U.S. stocks experienced a slight increase, with the Dow Jones up 0.1% to 47,930.00, NASDAQ rising 0.01% to 23,454.19, and S&P 500 gaining 0.1% to 6,856.66 [1] - Financial shares saw a rise of 0.4%, while health care stocks fell by 0.6% [1] Company Performance - Dollar General Corporation's shares surged over 7% after reporting Q3 earnings of $1.28 per share, exceeding the analyst consensus estimate of 95 cents, and quarterly sales of $10.649 billion, surpassing the estimate of $10.639 billion [2] Commodity Market - Oil prices decreased by 0.2% to $58.86, while gold prices increased by 0.1% to $4,234.70. Silver fell by 1.5% to $57.74, and copper dropped 0.5% to $5.3620 [5] International Markets - European shares rose, with the eurozone's STOXX 600 up 0.5%, Spain's IBEX 35 Index up 0.5%, London's FTSE 100 up 0.2%, Germany's DAX 40 gaining 0.9%, and France's CAC 40 rising 0.5% [6] - Asian markets closed mostly higher, with Japan's Nikkei gaining 2.33% and Hong Kong's Hang Seng rising 0.68% [7] Notable Stock Movements - Polyrizon Ltd. shares increased by 134% to $16.61 following positive preclinical test data [8] - KALA BIO, Inc. shares surged 50% to $1.39 after Oxford Finance LLC acquired a significant stake [8] - Genesco Inc. shares dropped 28% to $25.84 after reporting disappointing Q3 results and lowering FY26 guidance [8] - Cross Country Healthcare, Inc. shares fell 20% to $7.57 after terminating a merger agreement [8]
From Lab to Global Impact: Polyrizon's Journey to Potentially Redefining Next-Generation Nasal Protection
Globenewswire· 2025-12-04 12:32
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]
Why UiPath Shares Are Trading Higher By Around 9%; Here Are 20 Stocks Moving Premarket - Axogen (NASDAQ:AXGN), Addex Therapeutics (NASDAQ:ADXN)
Benzinga· 2025-12-04 09:48
Group 1: UiPath Financial Performance - UiPath Inc. reported third-quarter adjusted earnings of 16 cents per share, surpassing the Street estimate of 15 cents per share [1] - The company's quarterly revenue reached $411.11 million, exceeding the consensus estimate of $392.97 million and showing an increase from $354.65 million in the same period last year [1] Group 2: Stock Market Reaction - Following the positive financial results, UiPath shares rose 8.7% to $16.18 in pre-market trading [2]
Polyrizon Reports Positive Mucoadhesion Results for Intranasal Naloxone Hydrogel Compared to Marketed Intranasal Naloxone product
Globenewswire· 2025-12-03 14:28
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].
Polyrizon Announces Successful Completion of Key Manufacturing Upscaling Milestone for Its Nasal Spray Platform
Globenewswire· 2025-12-02 12:55
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]