Polyrizon Completes FDA Pre-Submission Meeting for PL-14 Allergy Blocker Nasal Spray
Polyrizon Ltd. - Ordinary Shares (PLRZ)
Company Research
Source: GlobeNewswire
Ra’anana, Israel, Dec. 08, 2025 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (Nasdaq: PLRZ) (“Polyrizon” or the “Company”), a biotechnology company focusing on the development of intranasal products, today announces that it has successfully completed a pre-submission meeting with the U.S. Food and Drug Administration (FDA) 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 disc
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- Polyrizon Submits Pre-Request for Designation to FDA for PL-16 Viral Blocker Designed to Reduce the Exposure to Influenza and Cold Viruses [Yahoo! Finance]Yahoo! Finance
- Polyrizon Submits Pre-Request for Designation to FDA for PL-16 Viral Blocker Designed to Reduce the Exposure to Influenza and Cold VirusesGlobeNewswire
- Polyrizon Announces Promising Permeation Kinetics Supporting Advancement of Its Intranasal Naloxone Hydrogel ProgramGlobeNewswire
- From Lab to Global Impact: Polyrizon's Journey to Potentially Redefining Next-Generation Nasal ProtectionGlobeNewswire
- Polyrizon Reports Positive Mucoadhesion Results for Intranasal Naloxone Hydrogel Compared to Marketed Intranasal Naloxone product [Yahoo! Finance]Yahoo! Finance
PLRZ
Sec Filings
- 12/19/25 - Form 6-K
- 12/12/25 - Form SCHEDULE
- 12/12/25 - Form SCHEDULE
- PLRZ's page on the SEC website