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Hello!
We wanted to give you a quick intraday update on our new alert, Polyrizon Ltd. (NASDAQ: PLRZ).
PLRZ opened at 16.47, a 12% gap up from the previous day’s close and so far the high of the day.
PLRZ is building a potential base for what could be a significant breakout opportunity.
PLRZ has a 20 and 50 day moving average of 13.92 and 13.58.
A breakout and close above its recent high of 17.95 could present increased upside potential.
In addition, PLRZ has announced multiple growth catalysts recently.
In June, the company announced:
“Polyrizon Makes Strong Progress: Receives Central IRB Approval for its Allergy Blocker Clinical Trial”
PLRZ announced it has “received central IRB approval to begin its first human clinical trial for NASARIX™, the Company's innovative nasal spray designed to block airborne allergens.”
Importantly:
“This approval from BRANY Institutional Review Board (granted June 18, 2026) is a key regulatory milestone for the Company. It confirms that the study protocol, patient consent forms, and trial materials have been reviewed and approved by the central IRB and satisfy applicable ethical and participant protection requirements.”
As the company further explains:
“The approved study, titled "Evaluation of the Efficacy, Safety, and Tolerability of NASARIXTM Allergy Blocker Compared to Saline Spray in Patients with Seasonal Allergic Rhinitis," is designed to assess the efficacy, safety, and tolerability of NASARIXTM in patients suffering from seasonal allergic rhinitis. The study will compare NASARIXTM against a saline spray control to evaluate symptom relief and overall patient outcomes.”
“The IRB reviewed and approved the clinical protocol (PL14-CTP-01), associated instructions for use, informed consent documents, quality-of-life assessments, and electronic diary tools that will be used during the study.”
Here are some of the company’s comments from this press release:
"This IRB approval represents an important milestone in the advancement of our NASARIXTM clinical development program," said Tomer Izraeli, CEO. "We are pleased to have received approval for the study master file and look forward to progressing toward site activation and patient enrollment following completion of site-specific IRB approvals."
In addition, earlier this month, the company announced:
“Polyrizon Announces Successful Results for NASARIX™ Biocompatibility Program, Supporting Advancement Towards First in Human Clinical Trial”
PLRZ announced “successful results from its biocompatibility evaluation program for its proprietary NASARIXTM Allergy Blocker nasal spray, with all required biological safety tests meeting their predetermined acceptance criteria.”
As the company further explains:
“The comprehensive evaluation program was designed in accordance with internationally recognized standards for biological safety assessment of medical devices, including the ISO 10993 series, FDA guidance, and applicable European regulatory requirements. The program was developed to assess the safety and biocompatibility profile of NASARIXTM, a drug-free mucoadhesive nasal spray intended to help reduce exposure to airborne allergens associated with seasonal allergic rhinitis.”
“The completed testing program evaluated key biological safety endpoints identified for the device, including:
Cytotoxicity
Sensitization
Irritation / Intracutaneous Reactivity
Material-Mediated Pyrogenicity
Acute Systemic Toxicity”
In addition, “long-term systemic toxicity was assessed through a toxicological risk assessment conducted in accordance with ISO 10993-17, demonstrating substantial safety margins across the product's constituent materials under intended conditions of use.”
“The biocompatibility evaluation was based on the final NASARIXTM product configuration and supported by extensive toxicological assessments of the formulation components, manufacturing processes, packaging materials, and intended patient exposure. According to the Biological Evaluation Plan, the product consists of well-characterized materials with established safety profiles and utilizes a manufacturing process designed to minimize biological risk.”
Furthermore:
“The biocompatibility evaluation program was developed under a risk-management framework consistent with ISO 10993-1 and ISO 14971 and included assessment of physical and chemical characteristics, material safety data, toxicological literature, manufacturing controls, and endpoint-specific biological testing.”
Plus:
“The successful completion of the biocompatibility program further strengthens the non-clinical package supporting NASARIXTM and represents an important step toward potential commercialization of the product as a novel nasal barrier technology designed to help individuals suffering from seasonal allergies.”
We are continuing to monitor PLRZ for a sustainable breakout higher.
Happy Trading!
SmallCapStocks Team
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