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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PLRZ
Sec Filings
- 2/6/26 - Form 6-K
- 2/4/26 - Form 6-K
- 1/22/26 - Form 6-K
- PLRZ's page on the SEC website