Polyrizon Submits Pre-Sub Package to the FDA for PL-14 Allergy Blocker
Polyrizon (NASDAQ:PLRZ) has submitted a pre-submission package to the FDA for its PL-14 Allergy Blocker, marking a significant regulatory milestone. The novel nasal spray creates a physical barrier to block allergens and provide relief from allergic rhinitis symptoms.
The comprehensive submission includes manufacturing plans, clinical development strategies, and regulatory pathways. PL-14 is designed to alleviate mild nasal irritation symptoms caused by various airborne allergens, including environmental pollens, house dust, animal hairs, and dust mites.
Polyrizon (NASDAQ:PLRZ) ha presentato un pacchetto pre-sottomissione alla FDA per il PL-14 Allergy Blocker, segnando una tappa regolatoria significativa. Il nuovo spray nasale crea una barriera fisica per bloccare gli allergeni e offrire sollievo dai sintomi della rinite allergica.
La submission completa include
Polyrizon (NASDAQ:PLRZ) ha presentado un paquete de preenvío a la FDA para su PL-14 Allergy Blocker, marcando un hito regulatorio significativo. El novedoso spray nasal crea una barrera física para bloquear los alérgenos y proporcionar alivio de los síntomas de la rinitis alérgica.
La presentación integral incluye planes de fabricación, estrategias de desarrollo clínico y rutas regulatorias. PL-14 está diseñado para aliviar los síntomas leves de irritación nasal causados por varios alérgenos presentes en el aire, incluyendo polen ambiental, polvo doméstico, pelos de animales y ácaros del polvo.
Polyrizon (NASDAQ:PLRZ)은 PL-14 알레르기 차단제에 대한 FDA 사전제출 패키지를 제출했으며, 이는 중요한 규제 이정표를 나타낸다. 이 혁신적 비강 스프레이는 알레르겐을 차단하고 알레르기성 비염 증상을 완화하기 위한 물리적 장벽을 만든다.
포괄적인 제출물에는 제조 계획, 임상 개발 전략 및 규제 경로가 포함된다. PL-14는 환경적 꽃가루, 가정먼지, 동물 털, 집먼지 진드기 등 다양한 공기 중 알레르겐으로 인한 경미한 비강 자극 증상을 완화하도록 설계되었다.
Polyrizon (NASDAQ:PLRZ) a soumis un dossier de pré-soumission à la FDA pour son PL-14 Allergy Blocker, marquant une étape réglementaire majeure. Le nouveau spray nasal crée une barrière physique pour bloquer les allergènes et soulager les symptômes de la rhinite allergique.
La soumission complète comprend des plans de fabrication, des stratégies de développement clinique et des voies réglementaires. Le PL-14 est conçu pour atténuer les symptômes légers d'irritation nasale causés par divers allergènes présents dans l'air, notamment les pollens environnementaux, la poussière domestique, les poils d'animaux et les acariens.
Polyrizon (NASDAQ:PLRZ) hat der FDA ein Vorab-Einreichungspaket für PL-14 Allergy Blocker vorgelegt, was einen bedeutenden regulatorischen Meilenstein darstellt. Das neuartige Nasenspray schafft eine physische Barriere gegen Allergene und lindert Symptome der allergischen Rhinitis.
Die umfassende Einreichung umfasst Herstellungspläne, Strategien zur klinischen Entwicklung und regulatorische Wege. PL-14 soll milde Nasenreizungen durch verschiedene luftübertragene Allergene lindern, darunter Umweltpollen, Hausstaub, Tierhaare und Hausstaubmilben.
Polyrizon (NASDAQ:PLRZ) قدمت حزمة ما قبل التقديم إلى هيئة الغذاء والدواء الأمريكية FDA لمنتج PL-14 Allergy Blocker، مما يمثل علامة تنظيمية مهمة. الرذاذ الأنفي الجديد يخلق حاجزاً مادياً لعرقلة المسببات المرتبطة بالحساسية وتخفيف أعراض التهاب الأنف التحسسي.
يتضمن التقديم الشامل خطط التصنيع، واستراتيجيات التطوير العلاجي، ومسارات التنظيم. صُمم PL-14 لتخفيف الأعراض الخفيفة لتهيج الأنف الناتجة عن مجموعة من المسببات الجوية، بما في ذلك الغبار pollen البيئي، وغبار المنزل، وفراء الحيوانات، وعث الغبار.
Polyrizon (NASDAQ:PLRZ) 已向FDA提交了PL-14过敏阻断剂的预提交包，标志着重要的监管里程碑。新型鼻喷雾通过创造物理屏障来阻挡过敏原并缓解过敏性鼻炎症状。
完整提交包括制造计划、临床开发策略和监管路径。PL-14旨在缓解由多种空气传播的过敏原引起的轻度鼻腔刺激症状，包括环境花粉、家尘、动物毛发和尘螨。
- Submission of FDA pre-submission package represents regulatory progress
- Product addresses large market with hundreds of millions of potential users worldwide
- Non-invasive solution targeting multiple types of airborne allergens
- Product still in early regulatory phase without FDA approval
- No clinical efficacy data disclosed in the announcement
Insights
Polyrizon's FDA pre-submission for PL-14 Allergy Blocker marks a modest regulatory milestone, though still early in approval journey.
Polyrizon's FDA pre-submission package for PL-14 represents a preliminary regulatory step in the company's commercialization journey. While this is procedurally important, investors should understand that a pre-submission is primarily a consultation mechanism with the FDA—not an approval application.
The company's PL-14 product employs a physical barrier approach to allergic rhinitis treatment, differentiating it from traditional pharmacological interventions. This mechanistic strategy could potentially offer advantages in the safety profile, as physical barriers typically raise fewer systemic safety concerns than drug-based approaches.
The market opportunity here is substantial—allergic rhinitis affects hundreds of millions globally, creating a large addressable market. However, this is also a competitive landscape with numerous over-the-counter and prescription options already available.
From a regulatory perspective, the company appears to be pursuing a medical device pathway rather than a drug approval process, suggested by the "marketing clearance" language. This typically involves a less rigorous review process than new drug applications, potentially enabling a faster path to market if successful.
This milestone indicates Polyrizon is executing on its development strategy, but represents an early step in a multi-stage regulatory process. Significant development hurdles remain before commercialization becomes possible, including potential clinical trials and manufacturing validation.
Ra’anana, Israel, Sept. 19, 2025 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (Nasdaq: PLRZ) (“Polyrizon” or the “Company”), a biotechnology company focusing on the development of intranasal products, today announced the submission of its full pre-submission (Pre-Sub) package to the U.S. Food and Drug Administration (FDA) for its PL-14 product, designed to help individuals suffering from nasal allergies. The submission includes comprehensive documentation covering manufacturing plans, clinical development strategies, and regulatory pathways. This submission represents a significant progress in Polyrizon’s regulatory strategy, paving the way for potential marketing clearance and addressing a critical unmet need in allergy treatment.
Polyrizon’s PL-14 Allergy Blocker is a novel, non-invasive nasal spray that forms a physical barrier designed to provide rapid, long-lasting relief from allergic rhinitis symptoms by blocking allergen entry. The PL-14 Allergy Blocker is intended to treat allergy sufferers by promoting the alleviation of mild allergic symptoms (i.e., mild nasal irritation including itchy, runny, or congested nasal passages) triggered by the inhalation of various airborne allergens including indoor and outdoor environmental pollens, house dust, animal hairs, and dust mites.
“We are pleased to submit this Pre-Sub to the FDA, a crucial step in our journey to bring PL-14 Allergy Blocker to market,” said Tomer Izraeli, CEO of Polyrizon. “Allergic rhinitis affects hundreds of millions of people worldwide, and we believe that our innovative approach has the potential to transform treatment options. This submission positions Polyrizon for accelerated development in this high-demand therapeutic area.”
About Polyrizon
Polyrizon is a development stage biotech company specializing in the development of innovative medical device hydrogels delivered in the form of nasal sprays, which form a thin hydrogel-based shield containment barrier in the nasal cavity that can provide a barrier against viruses and allergens from contacting the nasal epithelial tissue. Polyrizon’s proprietary Capture and Contain TM, or C&C, hydrogel technology, comprised of a mixture of naturally occurring building blocks, is delivered in the form of nasal sprays, and potentially functions as a “biological mask” with a thin shield containment barrier in the nasal cavity. Polyrizon are further developing certain aspects of our C&C hydrogel technology such as the bioadhesion and prolonged retention at the nasal deposition site for intranasal delivery of drugs. Polyrizon refers to its additional technology, which is in an earlier stage of pre-clinical development, that is focused on nasal delivery of active pharmaceutical ingredients, or APIs, as Trap and Target ™, or T&T. For more information, please visit https://polyrizon-biotech.com.
Forward Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses how this submission represents significant progress in Polyrizon’s regulatory strategy, paving the way for potential marketing clearance and addressing a critical unmet need in allergy treatment, its journey to bring PL-14 Allergy Blocker to market, its belief that its innovative approach has the potential to transform treatment options and how this submission positions Polyrizon for accelerated development in this high-demand therapeutic area. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission (“SEC”), including, but not limited to, the risks detailed in the Company’s annual report filed with the SEC on March 11, 2025 and subsequent filings with the SEC. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Polyrizon is not responsible for the contents of third-party websites.
Contacts:
Michal Efraty
Investor Relations
FAQ
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