Polyrizon Submits Pre-Sub Package to the FDA for PL-14 Allergy Blocker

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.