As Flu Surge Continues, Polyrizon's Nasal Spray Emerges as Potential Extra Shield Solution for Both Vaccinated and Unvaccinated

Rhea-AI Summary

Polyrizon (Nasdaq: PLRZ) highlighted its PL-16 Viral Blocker nasal spray as a complementary, non-pharmaceutical layer of protection during the intensifying 2025–2026 U.S. flu season. Public-health context includes CDC estimates of at least 4.6 million illnesses, 49,000 hospitalizations, and 1,900 deaths, and a reported ~3 million fewer vaccine doses administered compared with last year.

Polyrizon describes PL-16 as a hydrogel that forms a temporary physical barrier on nasal mucosa; preclinical in‑vitro studies reportedly showed over 90% protection of cells from varied viruses. On Dec 19, 2025 the company submitted a Pre-Request for Designation to the FDA as an OTC product to reduce viral exposure.

Positive

• Preclinical efficacy reported as over 90% cell protection
• Submitted Pre-Request for Designation to FDA on Dec 19, 2025
• Non-drug physical mechanism that the company says avoids antiviral resistance

Negative

• No clinical human data reported in the announcement
• Regulatory status remains preliminary after a pre-request, not an approval

Key Figures

Flu illnesses 4.6 million CDC estimate for 2025–2026 U.S. season as of late Dec 2025

Flu hospitalizations 49,000 CDC estimate for 2025–2026 U.S. season

Flu deaths 1,900 CDC estimate for 2025–2026 U.S. season

Vaccine doses 47 million Flu vaccine doses administered in U.S. so far this season

Dose shortfall 3 million Decline in administered flu doses vs prior year

PL-16 protection over 90% Preclinical in-vitro protection of cells from viral infections

Market Reality Check

$12.75 Last Close

Volume Volume 44,544 is 0.02x the 20-day average of 2,109,901, indicating muted trading interest pre‑news. low

Technical Shares at $8.49 are trading below the $140.05 200-day MA and about 99.8% under the $4,200 52-week high.

Peers on Argus 1 Up

PLRZ is up 3.35% while key biotech peers show mixed moves, with several down (e.g., ADTX -6.24%, ENSC -4.17%) and no clear sector-wide catalyst.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 29	Capital allocation update	Positive	-1.4%	Board explores revenue-generating real assets while highlighting strong cash and no debt.
Dec 19	PL-16 FDA Pre-RFD	Positive	-6.7%	Submission of FDA Pre-RFD for PL-16 viral blocker with >90% protection in tests.
Dec 11	Naloxone hydrogel data	Positive	+11.5%	Preclinical intranasal naloxone results show stability, mucoadhesion and rapid permeation.
Dec 08	PL-14 FDA meeting	Positive	-15.7%	Completed FDA pre-submission meeting and outlined PL-14 clinical strategy for 2026.
Dec 04	PL-14 scale-up milestone	Positive	+104.0%	Larger-scale PL-14 batches meet quality specs, validating C&C platform manufacturing.

Pattern Detected

Recent news has been largely positive, yet price reactions often diverged, with 3 negative and 2 positive moves on upbeat updates, including one triple‑digit spike.

Recent Company History

Over the last month, Polyrizon has reported several milestones around its intranasal platforms. On Dec 4, 2025, a manufacturing milestone for PL‑14 and validation of the Capture & Contain™ platform preceded a 104.02% move. Subsequent PL‑14 regulatory interactions and naloxone hydrogel data on Dec 8 and Dec 11 showed mixed price follow‑through. Later in December, PL‑16 regulatory progress and a capital allocation update drew negative reactions, framing today’s flu‑season PL‑16 spotlight against a volatile response history.

Regulatory & Risk Context

Active S-3 Shelf Registration 2025-11-07

$50,000,000 registered capacity

An effective-date-pending Form F-3 filed on Nov 7, 2025 allows Polyrizon to offer up to $50,000,000 of securities, including ordinary shares, warrants and units, via methods such as at-the-market offerings or negotiated deals. With 0 recorded takedowns so far, the shelf provides capacity for future capital raises that could support operations, development, and strategic opportunities once effective.

Market Pulse Summary

The stock surged +50.2% in the session following this news. A strong positive reaction aligns with the flu-season context highlighting PL‑16’s potential role as a non-pharmaceutical barrier offering over 90% in‑vitro protection. Past news showed volatile responses, including a 104.02% spike on a PL‑14 milestone and several selloffs on positive updates. The existing $50,000,000 Form F‑3 capacity also framed expectations for possible future capital raises alongside clinical and regulatory progress.

Key Terms

pre-request for designation regulatory

"Polyrizon announced the submission of a Pre-Request for Designation to the FDA"

A pre-request for designation is an early, informal inquiry a company sends to regulators to check whether a product might qualify for a special regulatory status before filing a formal application. It matters to investors because it signals the company is probing a faster or more favorable review pathway that can shorten timelines, lower development risk, and potentially increase the asset’s value—much like asking a store clerk if an item qualifies for a discount before buying.

fda regulatory

"submission of a Pre-Request for Designation to the FDA for PL-16"

The FDA is the U.S. federal agency that evaluates and approves medical drugs, devices, biological therapies and certain foods; think of it as the gatekeeper that decides whether a medical product is safe and effective for patients. For investors, FDA decisions determine whether a company can sell a product, affect expected revenue and introduce regulatory risk, so approvals, rejections or safety warnings can quickly move a company's valuation and stock price.

over-the-counter regulatory

"a key step toward potential over-the-counter status as a product"

Over-the-counter describes securities or trades that occur directly between buyers and sellers rather than on a formal stock exchange. Think of it like buying at a flea market instead of a big supermarket: prices, rules and transparency can vary, which can mean lower liquidity, wider price swings and less regulatory oversight—factors investors watch because they affect ease of trading and risk level.

nasal mucosa medical

"creates a thin, temporary physical barrier on the nasal mucosa that potentially"

The nasal mucosa is the soft, moist lining inside the nose that produces mucus and acts like a protective carpet or sponge, trapping particles and helping control moisture and air flow. For investors, its condition determines how well nasal drugs, vaccines or diagnostic swabs are absorbed and tolerated, so findings about irritation, effectiveness, or delivery can materially affect regulatory approval, market potential and commercial success of related products.

hydrogel medical

"PL-16 Viral Blocker, is a non-pharmaceutical hydrogel nasal spray based on"

A hydrogel is a soft, jelly-like material made mostly of water combined with a network of flexible, supportive molecules. Its unique ability to hold large amounts of water while remaining stable makes it useful in various medical, industrial, and consumer applications. For investors, innovations involving hydrogels can signal growth opportunities in sectors like healthcare, biotechnology, and advanced materials.

world health organization regulatory

"According to the World Health Organization, which monitors the flu status"

The World Health Organization is the United Nations agency that coordinates international public health efforts, tracks disease outbreaks, and issues guidance on vaccines, treatments and health policy. Investors watch its statements like a global referee’s call: its guidance can change demand, alter regulatory priorities, and affect sectors such as pharmaceuticals, travel, and insurance, making it a key source of market-moving information about health risks and policy shifts.

AI-generated analysis. Not financial advice.

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

IR@polyrizon-biotech.com

FAQ

What did Polyrizon announce for PL-16 on January 2, 2026 (PLRZ)?

Polyrizon announced PL-16 as a hydrogel nasal spray and said it submitted a Pre-Request for Designation to the FDA on Dec 19, 2025.

What efficacy data does Polyrizon report for PL-16 (PLRZ)?

The company reported preclinical in‑vitro studies showing over 90% protection of cells from variable viral infections.

Will PL-16 be available over the counter and when for PLRZ shareholders?

Polyrizon has submitted a pre‑request to pursue potential OTC designation, but no approval or timeline was announced.

How does PL-16 work against influenza according to Polyrizon (PLRZ)?

PL-16 is described as a hydrogel that forms a thin physical barrier on the nasal mucosa to capture and contain respiratory viruses before cell infection.

Does Polyrizon claim PL-16 replaces flu vaccination (PLRZ)?

No; the company presents PL-16 as a complementary, drug‑free layer to vaccines, masks, and hygiene, not a replacement for vaccination.