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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.
Posted In: PLRZ
