Polyrizon Ltd. (Nasdaq: PLRZ) completed a pre‑submission meeting with the U.S. Food and Drug Administration on December 8, 2025, to discuss its PL‑14 Allergy Blocker nasal spray. The meeting covered the company’s development program plan, manufacturing process, analytical and quality controls, and the stability program that will support future regulatory submissions. Polyrizon also reviewed its biocompatibility assessment package and additional preclinical studies aligned with the FDA’s “Guidance for Nasal Spray and Inhalation Drug Products.”
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Polyrizon Ltd. reported that its Trap & Target (T&T) intranasal naloxone hydrogel achieved markedly higher mucoadhesion than the currently marketed intranasal naloxone spray in an ex‑vivo rabbit nasal mucosa study. The hydrogel retained significantly more residual fluorescence after 30 minutes of washing with simulated nasal electrolyte solution, with a p‑value of less than 0.0001, indicating a robust statistical difference.
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Polyrizon Ltd. (Nasdaq: PLRZ) completed a critical manufacturing upscaling milestone for its PL‑14 intranasal spray platform on December 2 2025. The company’s CEO, Tomer Izraeli, highlighted that the transition from small‑batch laboratory production to a larger‑scale, controlled manufacturing run validated the PL‑14 formulation and confirmed that the product can be reliably produced at increased batch volumes while maintaining high‑quality specifications.
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