Polyrizon Ltd Stock Price, News & Analysis

Polyrizon (Nasdaq: PLRZ) reported in-vitro pre-clinical results for its PL-14 Allergy Blocker showing significantly reduced transfer of the house dust mite allergen Der p 1 versus the standard comparator HPMC in a validated Transwell permeability model.

Key data: PL-14 reduced Der p 1 transfer at all time points (1, 2, 4, 6, 24 hours) with p ≤ 0.0042. At 1 hour mean Der p 1 was ~20.6 ng for PL-14 versus ~1,354.4 ng for HPMC; HPMC rose to ~5,201.2 ng at 24 hours while PL-14 peaked at ~141.2 ng at 4 hours. The company said it will advance PL-14 toward clinical studies to define regulatory pathway and real-world benefit.

Polyrizon (Nasdaq: PLRZ) highlighted its PL-16 Viral Blocker nasal spray as a complementary, non-pharmaceutical layer of protection during the intensifying 2025–2026 U.S. flu season. Public-health context includes CDC estimates of at least 4.6 million illnesses, 49,000 hospitalizations, and 1,900 deaths, and a reported ~3 million fewer vaccine doses administered compared with last year.

Polyrizon describes PL-16 as a hydrogel that forms a temporary physical barrier on nasal mucosa; preclinical in‑vitro studies reportedly showed over 90% protection of cells from varied viruses. On Dec 19, 2025 the company submitted a Pre-Request for Designation to the FDA as an OTC product to reduce viral exposure.

Polyrizon (Nasdaq: PLRZ) said on Dec 29, 2025 that its board has authorized exploration of realistic investments in revenue-generating real assets while maintaining focus on its core intranasal medical pipeline.

The company reiterated commitment to product development, preclinical and clinical studies, and regulatory progress for programs including PL-14 (allergy blocker), PL-16 (viral blocker), and the Trap & Target intranasal drug-delivery platform. The board cited the company’s strong cash position and debt-free balance sheet as enabling factors and said updates will be provided if material developments occur.

Polyrizon (PLRZ) said on Dec 19, 2025 it submitted a Pre-Request for Designation (Pre-RFD) to the U.S. FDA for PL-16 Viral Blocker, a non‑pharmacological intranasal product designed to form a temporary physical barrier on the nasal mucosa to reduce exposure to influenza and cold viruses.

The company reported that PL-16 showed over 90% protection in cell-based tests and that the Pre-RFD opens a formal regulatory dialogue about the appropriate pathway based on formulation and physical mode of action.

The release cites CDC model estimates for the 2025–2026 flu season (at least 2.9M symptomatic illnesses, 1.4M medical visits, 30,000 hospitalizations, and 1,200 deaths) as context for respiratory‑infection risk.

Polyrizon (Nasdaq: PLRZ) reported preclinical results for its intranasal naloxone hydrogel on December 11, 2025, showing three supporting data pillars: stability, superior mucoadhesion versus a marketed product (p < 0.0001), and rapid permeation comparable to the commercial benchmark.

The company completed permeation studies in a validated artificial membrane system and found no statistically significant difference in naloxone diffusion rates versus the reference product, indicating enhanced nasal residence time did not delay drug permeation. Polyrizon says these results support potential advancement of the candidate and highlight its Trap & Target™ hydrogel as a way to combine mucosal retention with fast onset.

Polyrizon (Nasdaq: PLRZ) completed an FDA pre-submission meeting on Dec 8, 2025 for its PL-14 Allergy Blocker intranasal spray.

The company presented its proposed manufacturing process, analytical and quality controls, stability program, biocompatibility package, and additional preclinical studies aligned with FDA guidance for nasal spray products. Polyrizon outlined a clinical development strategy with trials expected to commence in 2026. A market report projects the global allergen blocker market to reach USD $210M by 2033.

Polyrizon (Nasdaq: PLRZ) announced a pivotal manufacturing milestone on December 2, 2025, producing larger-scale batches of its flagship intranasal hydrogel, PL-14 Allergy Blocker, with runs meeting specifications for consistency, stability, and quality.

The successful CDMO production validates the company’s Capture & Contain™ (C&C) platform manufacturing strategy, enables supply for planned clinical trials in 2026, and supports potential future commercial scale-up. The company highlights market opportunities in seasonal allergic rhinitis (estimated USD 11.14B in 2025) and influenza markets while noting continued R&D on Trap & Target™ (T&T) for nasal drug delivery.

Polyrizon (Nasdaq: PLRZ) reported preclinical ex-vivo results on Dec 3, 2025 showing its proprietary naloxone Trap and Target (T&T) hydrogel adhered to rabbit nasal mucosa longer than a marketed intranasal naloxone spray.

In a 30-minute simulated nasal wash study using residual fluorescence quantification, the hydrogel retained significantly higher fluorescence than the commercial product (p < 0.0001, two-way ANOVA), indicating stronger mucoadhesion that may support prolonged nasal residence and potentially improved intranasal absorption.

Polyrizon (Nasdaq: PLRZ) announced the successful completion of a key manufacturing upscaling milestone for its intranasal C&C platform on Dec 2, 2025. The company and its CDMO transitioned PL-14 from small-batch lab production to a larger-scale controlled run that validated key formulation parameters and showed the PL-14 formulation can be reliably produced at increased batch volumes while maintaining quality.

The batch is intended to support clinical trial material (CTM) for a clinical trial expected to commence in 2026 and is described as produced in line with U.S. and European regulatory standards, advancing readiness for clinical and regulatory activities and potential future commercial manufacturing.