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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.
Polyrizon (PLRZ) has successfully closed its initial public offering (IPO) of 958,903 units at $4.38 per unit, raising gross proceeds of $4.2 million. Each unit consists of one ordinary share and three warrants, with each warrant exercisable at $4.38 per share. The company granted Aegis Capital Corp. a 45-day option to purchase up to 143,835 additional units for over-allotments, potentially increasing total gross proceeds to $4.82 million. Proceeds will fund preclinical and clinical development, research, debt repayment, working capital, and possible acquisitions.
Polyrizon has announced the pricing of its initial public offering on the Nasdaq Capital Market under the symbol 'PLRZ'. The company is offering 958,903 units at $4.38 per unit, with each unit consisting of one ordinary share and three warrants. The offering is expected to raise $4.2 million in gross proceeds, potentially reaching $4.82 million if the underwriter's over-allotment option is exercised. Trading is set to begin on October 29, 2024. The company plans to use proceeds for preclinical and clinical development, research, debt repayment, working capital, and potential acquisitions.
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