Polyrizon Ltd Stock Price, News & Analysis

Polyrizon (Nasdaq: PLRZ) has initiated preclinical studies for intranasal Naloxone, targeting opioid overdose treatment using its proprietary Trap and Target™ (T&T) platform. The study will be conducted in collaboration with Professor Fabio Sonvico from the University of Parma, focusing on key parameters like drug loading capacity, release kinetics, nasal deposition, and stability.

The company aims to enhance intranasal Naloxone delivery by improving bioavailability and optimizing drug release profiles for rapid opioid reversal in emergency situations. This development addresses the ongoing global opioid crisis, particularly driven by fentanyl and synthetic opioids.

Market projections indicate significant growth potential:

• Global Naloxone market expected to reach $2.47 billion by 2032 (11% CAGR)
• Naloxone intranasal spray market projected to hit $1.4 billion by 2030

Polyrizon (PLRZ) has filed a divisional patent application in Israel for its Trap & Target (T&T) platform technology, focusing on advanced intranasal drug delivery systems. This follows their recent U.S. patent application covering both T&T and Capture and Contain (C&C) platforms.

The T&T platform aims to enhance medication effectiveness through improved nasal residence time and mucosal contact. Key features include prolonged residence time, improved bioavailability, controlled release, drip prevention, biodegradable components, and compatibility with various drug types including small molecules, proteins, peptides, and antibodies.

The technology leverages nasal cavity vascularization for both local and systemic drug delivery, targeting applications such as corticosteroids for allergic rhinitis, benzodiazepines for epileptic seizures, and naloxone for opioid overdose.

Polyrizon has initiated preliminary Good Manufacturing Practice (GMP) manufacturing process for its PL-14 allergy blocker in preparation for planned 2025 clinical trials. The company has partnered with Eurofins CDMO Amatsiaquitaine S.A.S. as their GMP manufacturer to support future commercialization efforts.

The designated manufacturing facility is equipped to meet clinical trial material requirements, ensuring high-quality production and regulatory compliance. The upcoming trial will evaluate PL-14's safety and efficacy as an innovative allergy blocker, delivered through proprietary nasal spray solutions.

According to CEO Tomer Izraeli, the global nasal spray market is projected to exceed $23 billion by 2029. The company aims to address growing market demand with their novel intranasal solution, which they believe could enhance current allergy treatment options.

Polyrizon (PLRZ) has announced the publication of a national phase patent application by the USPTO for its intranasal hydrogel technologies. The patent application covers two core platforms: Capture and Contain (C&C™) and Trap and Target (T&T™).

The C&C™ platform features a natural 3D polymeric network that adheres to nasal mucosa, creating a physical barrier against airborne biological threats like allergens, viruses, and molds. The T&T™ platform is designed for enhanced drug delivery, offering prolonged residence time and close mucosal contact for improved therapeutic efficacy. The technology can be customized for various molecules and medical applications.

Polyrizon (Nasdaq: PLRZ) has appointed Dr. Michal Meir as Senior Director of Regulatory and Clinical Affairs. This strategic appointment comes as the company prepares for its PL-14 clinical trial, scheduled to begin in 2025. Dr. Meir, currently a Senior Consultant at MedTech SME , brings over a decade of experience in medical device and pharmaceutical industries. Her expertise spans regulatory strategy, clinical affairs management, and product development, with previous leadership roles at Medtech SME , Keystone Heart, and Alma Lasers. The appointment aligns with Polyrizon's focus on developing innovative intranasal hydrogels and strengthening its regulatory compliance and clinical excellence capabilities.

Polyrizon has entered into a manufacturing agreement with Eurofins CDMO Amatsiaquitaine S.A.S, a European-based GMP manufacturer, to produce Clinical Trial Material for its PL-14 allergy blocker. The collaboration aims to prepare for a clinical trial expected to begin in 2025.

The EU-based facility offers large-scale commercial production capabilities and will support Polyrizon's future commercialization efforts. The manufacturer will provide CTM production that meets both USA and European regulatory standards, marking a significant step in the company's preparation for evaluating PL-14's safety and efficacy as an allergy blocker delivered through nasal spray technology.

Polyrizon (Nasdaq: PLRZ), a development stage biotech company focused on innovative intranasal hydrogels, has appointed Asaf Azulay as Vice President of Regulatory Affairs and Quality Assurance (RA/QA). Azulay, currently Managing Director of Eurofins' Li-Med team, brings over 20 years of experience in the medical devices industry.

The appointment aligns with Polyrizon's commitment to maintaining high industry standards while advancing its product pipeline. CEO Tomer Izraeli emphasized that Azulay's expertise will be important in navigating complex regulatory environments and advancing the company's product portfolio. The role aims to ensure innovation progress while maintaining patient safety as regulations become more stringent.

Polyrizon has signed a manufacturing agreement with Eurofins CDMO Amatsiaquitaine S.A.S, a European-based GMP manufacturer, to produce Clinical Trial Material for its PL-14 allergy blocker. The collaboration aims to support the upcoming clinical trial scheduled for 2025, which will evaluate PL-14's safety and efficacy as an intranasal hydrogel for allergy protection. The EU-based facility offers large-scale commercial production capabilities and complies with USA and European regulatory standards, positioning Polyrizon for future commercialization efforts.

Aegis Capital Corp has successfully served as the Sole Bookrunner for Polyrizon 's Initial Public Offering (IPO) on the NASDAQ under the symbol PLRZ. The IPO raised a total of $4.2 million. The offering marks Polyrizon's debut on the public markets, with the transaction completed on October 30, 2024.