A new flu strain is rising, while Polyrizon's PL-16 nasal spray offers a potential complementary preventive approach.
Quiver AI Summary
As the 2025-2026 flu season escalates in the United States, a mutated strain of influenza A is contributing to significant health impacts, with CDC reporting 4.6 million illnesses, 49,000 hospitalizations, and 1,900 deaths. Vaccination rates have declined, leaving many more vulnerable to illness. In response, Israeli biotech company Polyrizon Ltd. has developed a nasal spray called PL-16, which is designed to create a physical barrier in the nasal cavity to capture respiratory viruses like influenza. This innovative product is currently seeking FDA designation for potential over-the-counter availability, aiming to provide additional protection during flu season, especially for individuals who are either vaccinated or unvaccinated. The company emphasizes that PL-16 offers a drug-free layer of defense, forming part of a comprehensive approach to stay ahead of the flu.
Potential Positives
- Polyrizon's PL-16 Viral Blocker has demonstrated over 90% protection in preclinical studies, positioning the company as a promising player in the fight against respiratory viruses during a critical flu season.
- The submission of a Pre-Request for Designation to the FDA for PL-16 indicates progress towards potential over-the-counter status, which could enhance market access and consumer awareness of the product.
- PL-16 offers a complementary approach to existing flu prevention methods, which may increase its appeal to a broader audience, including those hesitant to receive vaccinations.
Potential Negatives
- Vaccination rates for the flu are down by about 3 million doses from the previous year, indicating potential public hesitancy or access issues regarding the vaccine, which could reflect negatively on the perceived efficacy of the company's product.
- The press release heavily emphasizes the experimental nature of Polyrizon's PL-16 product and its reliance on forward-looking statements, implying that the product is still in the development stage without guaranteed efficacy or regulatory approval.
- The mention of risks and uncertainties in forward-looking statements suggests potential challenges for the company, including market competition and the unpredictability of clinical outcomes that could affect its future performance.
FAQ
What strain is currently driving flu cases in the U.S.?
A mutated strain of influenza A is currently responsible for most flu cases across the United States.
How severe has the 2025-2026 flu season been?
The flu season has already led to at least 4.6 million illnesses, 49,000 hospitalizations, and 1,900 deaths nationwide.
What is Polyrizon's PL-16 Viral Blocker?
PL-16 is a hydrogel nasal spray that creates a protective barrier in the nasal mucosa to capture and contain respiratory viruses.
How does the PL-16 product prevent viral infections?
The product's physical mechanism offers over 90% protection from viral infections, without driving antiviral resistance.
What steps has Polyrizon taken for FDA approval of PL-16?
Polyrizon submitted a Pre-Request for Designation to the FDA, a step towards potential over-the-counter availability of PL-16.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
Raanana, Israel, Jan. 02, 2026 (GLOBE NEWSWIRE) -- As the 2025-2026 flu season intensifies across the United States, a mutated strain of influenza A is driving most cases, sparking concerns about a potentially tough winter ahead. According to the latest CDC estimates (as of late December 2025), flu has already caused at least 4.6 million illnesses, 49,000 hospitalizations, and 1,900 deaths nationwide.
Flu activity is rising sharply, with outpatient visits for influenza-like illness well above baseline in many states. Vaccination rates are lagging – over 47 million doses administered at pharmacies and offices so far, down about 3 million from last year – leaving more people vulnerable. While the vaccine remains the best defense, especially for preventing hospitalization, many choose not to vaccinate for various reasons, from personal beliefs to access issues.
According to the World Health Organization , which monitors the flu status all over the world, globally, influenza activity has increased since October 2025 with influenza A viruses predominant among the viruses detected globally. In many northern hemisphere countries, acute respiratory infection levels increase at this time of year. These increases are typically caused by seasonal epidemics of respiratory pathogens such as influenza, respiratory syncytial virus (RSV) and other common respiratory viruses.
This is where Israeli biotech company Polyrizon Ltd. (Nasdaq: PLRZ) offers a promising complementary approach. One of its leading product candidates, the PL-16 Viral Blocker, is a non-pharmaceutical hydrogel nasal spray based on the proprietary Capture & Contain (C&C) platform. It creates a thin, temporary physical barrier on the nasal mucosa that potentially capture and contains respiratory viruses – including influenza and common cold viruses – before they can infect cells.
Preclinical in-vitro studies have shown over 90% protection of cells from variable viral infections. Importantly, since the mechanism is purely physical, it doesn't drive antiviral resistance, unlike some medications and vaccines.
On December 19, 2025, Polyrizon announced the submission of a Pre-Request for Designation to the FDA for PL-16 – a key step toward potential over-the-counter status as a product to reduce exposure to respiratory viruses. Designed to complement vaccines, masks, and hygiene, PL-16 could be particularly valuable during high-activity seasons, providing a simple, non-invasive layer of defense.
In a season marked by early surges and a dominant drifted strain, experts stress layered protection. For the millions vaccinated and not vaccinated this year, innovations like Polyrizon's PL-16 has the potential to offer an additional, drug-free tool to help stay ahead of the flu.
About Polyrizon
Polyrizon is a development stage biotech company specializing in the development of innovative medical device hydrogels delivered in the form of nasal sprays, which form a thin hydrogel-based shield containment barrier in the nasal cavity that can provide a barrier against viruses and allergens from contacting the nasal epithelial tissue. Polyrizon’s proprietary Capture and Contain TM, or C&C, hydrogel technology, comprised of a mixture of naturally occurring building blocks, is delivered in the form of nasal sprays, and potentially functions as a “biological mask” with a thin shield containment barrier in the nasal cavity. Polyrizon are further developing certain aspects of our C&C hydrogel technology such as the bioadhesion and prolonged retention at the nasal deposition site for intranasal delivery of drugs. Polyrizon refers to its additional technology, which is in an earlier stage of pre-clinical development, that is focused on nasal delivery of active pharmaceutical ingredients, or APIs, as Trap and Target ™, or T&T. For more information, please visit https://polyrizon-biotech.com .
Forward Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses how innovations like Polyrizon's PL-16 has the potential offer an additional, drug-free tool to help stay ahead of the flu. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission (“SEC”), including, but not limited to, the risks detailed in the Company’s annual report filed with the SEC on March 11, 2025 and subsequent filings with the SEC. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Polyrizon is not responsible for the contents of third-party websites.
Contacts:
Michal Efraty
Investor Relations