Polyrizon completes FDA pre-submission meeting for PL-14 nasal spray

Polyrizon (PLRZ) completed a pre-submission meeting with the U.S. Food and Drug Administration regarding its PL-14 Allergy Blocker product, a novel nasal spray designed to provide protective intranasal barrier functionality. During the meeting, Polyrizon presented the general development program plan for PL-14, including the proposed manufacturing process, analytical and quality controls, and the structure of the stability program that will support future regulatory submissions. The Company also reviewed its planned biocompatibility assessment package and additional preclinical studies aligned with the FDA’s “Guidance for Nasal Spray and Inhalation Drug Products,” ensuring that all critical safety and performance elements are addressed. In addition, Polyrizon discussed the clinical development strategy for PL-14, towards the clinical trials that are expected to commence 2026, outlining the intended study designs and endpoints to support evaluation of safety and performance in accordance with FDA expectations. The Company believes that this pre-submission meeting represents a significant milestone, providing potential early regulatory alignment and clarity on key requirements. The constructive dialogue with the FDA will potentially enable Polyrizon to advance the PL-14 program efficiently and in full compliance with the high regulatory standards required for nasal spray products.