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Nasus Pharma Announces Positive Results from Preclinical Pharmacokinetic and Safety Study of Intranasal Ondansetron (NS003) 

(Positive)
Tags

Nasus Pharma (NYSE:NSRX) reported positive preclinical pharmacokinetic and safety results for NS003, its intranasal powder ondansetron for chemotherapy and post-operative nausea and vomiting.

In animal studies, NS003 showed a PK profile comparable to intravenous ondansetron and a favorable safety profile, supporting a planned first-in-human PK study in Q3 2026.

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Positive

  • NS003 intranasal ondansetron showed pharmacokinetic profile comparable to intravenous formulation in animal study
  • Toxicology study found favorable safety for NS003 at four times the test dose with no adverse effects
  • First-in-human pharmacokinetic study of NS003 planned to start in the third quarter of 2026
  • Pivotal study of intranasal anaphylaxis candidate NS002 targeted to begin in the fourth quarter of 2026

Negative

  • None.

News Market Reaction – NSRX

-0.34%
3 alerts
-0.34% Session close to close
+5.1% Peak Tracked
$37.97M Market Cap
0.4x Rel. Volume

In the Jun 9 session, NSRX declined 0.34%, reflecting a mild negative market reaction. Argus tracked a peak move of +5.1% during that session. Our momentum scanner triggered 3 alerts that day, indicating moderate trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement highlights encouraging preclinical pharmacokinetic and safety data for NS003, with...
Analysis

This announcement highlights encouraging preclinical pharmacokinetic and safety data for NS003, with a profile comparable to IV ondansetron and no adverse effects at the test dose. It extends Nasus’s intranasal platform alongside NS002, which delivered mixed market reactions to prior positive data. Investors may monitor the planned first-in-human PK study in Q3 2026, timelines for subsequent trials, and how the company manages capital needs while advancing multiple candidates.

Key Figures

Ondansetron prescriptions: 12 million prescriptions Patients treated: 6 million patients Zofran peak sales: $1.5 billion +5 more
8 metrics
Ondansetron prescriptions 12 million prescriptions Ondansetron use in 2023
Patients treated 6 million patients Ondansetron-treated patients in 2023
Zofran peak sales $1.5 billion Peak sales for ondansetron brand Zofran
Safety margin 4× test dose NS003 toxicology study dose with no adverse effects
US chemo patients 1 million patients Annual chemotherapy patients in the United States
Emetogenic regimens 60–80% Chemo patients on highly or moderately emetogenic regimens
Radiotherapy patients 800,000 patients Annual radiotherapy patients in the United States
Breakthrough CINV/RINV 15–20% of patients Patients with breakthrough nausea/vomiting despite oral therapies

Historical Context

5 past events · Latest: Jun 01 (Neutral)
Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Jun 01 KOL event announcement Neutral -0.6% Announcement of virtual KOL event to discuss NS002 Phase 2 data.
May 01 Investor conferences Neutral +1.9% Management participation in New York investor conferences with 1x1 meetings.
Mar 25 Pipeline and results update Positive +10.8% Positive NS002 Phase 2 topline data and annual results with pipeline timeline.
Mar 16 Phase 2 topline data Positive -40.6% NS002 Phase 2 data showing faster epinephrine delivery versus EpiPen.
Mar 09 Data presentation notice Neutral -15.4% Notice of upcoming NS002 Phase 2 topline analysis presentation and webcast.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

NSRX often reacts strongly to clinical milestones, with one notable divergence where positive Phase 2 NS002 data coincided with a 40.6% decline. Other corporate or event updates have shown modest, generally aligned moves.

Recent Company History

Over the last six months, Nasus Pharma has focused on advancing its intranasal pipeline. Positive Phase 2 data for NS002 on Mar 16, 2026 was followed by a 40.6% drop, while a broader business update and NS002 progression on Mar 25, 2026 saw shares gain 10.84%. Conference participation in early May produced a small positive reaction. More recently, a KOL event announcement for NS002 on Jun 1, 2026 had little price impact. Today’s NS003 preclinical results extend this intranasal platform story.

Key Terms

pharmacokinetic, intranasal, intravenous, tmax, +2 more
6 terms
pharmacokinetic medical
"announced positive results from a preclinical pharmacokinetic (“PK”) and safety study of NS003"
Pharmacokinetic describes how a drug moves through and leaves the body — how it is absorbed, spread to tissues, broken down and excreted — like tracking a package from pickup to delivery and disposal. For investors, these properties determine effective dose, safety risks, how often a medicine must be taken, and how reliably it works, which in turn influence clinical trial success, regulatory approval chances, production complexity and a drug’s commercial value.
intranasal medical
"proprietary intranasal powder formulation of ondansetron being developed"
Administration or delivery of a drug or vaccine through the nose, typically via a spray or drops that are absorbed by the nasal tissues. For investors, intranasal products can matter because they often offer easier, needle-free use, faster onset of effect, and potential cost or compliance advantages that can widen a product’s market and affect regulatory review, manufacturing complexity, and commercial prospects — similar to how a convenient app can outsell a clunky desktop program.
intravenous medical
"comparable pharmacokinetic profile to Intravenous Ondansetron in Animal Study"
Intravenous means delivering a drug, fluid or substance directly into a vein so it goes straight into the bloodstream. For investors, that matters because intravenous products often act faster, require different manufacturing, regulatory steps and healthcare settings (like hospitals or clinics), and can affect pricing, adoption and revenue profiles in ways that differ from pills or topical treatments — like turning a slow-release delivery into a direct tap to the system.
tmax medical
"with similar time to maximum concentration (Tmax) and area under the curve (AUC) results"
tmax is the time after a drug is taken when its level in the blood reaches its highest point. Investors care because it shows how quickly a medicine begins to act and can influence dosing convenience, side effects and market appeal — similar to how quickly coffee kicks in affects whether someone likes it and uses it regularly.
area under the curve (auc) medical
"time to maximum concentration (Tmax) and area under the curve (AUC) results"
Area under the curve (AUC) is a measurement of total drug exposure, calculated by adding up the drug concentration in the blood over time after a dose—think of it like totaling rainfall over a day to know how much water fell. Investors use AUC to judge how much of a medicine reaches the body, how long it lasts, and how it compares to alternatives, which affects dosing, safety, regulatory approval and commercial value.
toxicology medical
"In a separate toxicology study, NS003 demonstrated a favorable safety profile"
Toxicology is the science that studies how chemicals, drugs or other substances can harm people, animals or the environment and determines what exposure levels are safe. For investors, toxicology results act like a safety checklist: they influence whether a product can get regulatory approval, be sold without restrictions, or face recalls and legal risks—factors that can materially affect a company’s prospects and stock value.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Study Comparing Intranasal Powder Formulation of Ondansetron Demonstrates Comparable Pharmacokinetic Profile to Intravenous Ondansetron in Animal Study; 
Program to Advance to First-in-Human PK Study in Third Quarter of 2026

TEL AVIV, Israel, June 09, 2026 (GLOBE NEWSWIRE) -- Nasus Pharma Ltd. (NYSE: NSRX) (“Nasus Pharma” or the “Company”), a clinical-stage pharmaceutical company focused on the development of innovative intranasal products, today announced positive results from a preclinical pharmacokinetic (“PK”) and safety study of NS003, the Company’s proprietary intranasal powder formulation of ondansetron being developed for chemotherapy and post-operative nausea and vomiting.

Ondansetron is one of the most widely used therapies for chemotherapy-induced nausea and vomiting. In 2023, more than 12 million prescriptions were dispensed to over 6 million patients. Zofran (ondansetron) peak sales exceeded $1.5 billion.

The study compared NS003 to the intravenous (“IV”) formulation in an animal study. Data showed that NS003 had a PK profile comparable to IV, with similar time to maximum concentration (Tmax) and area under the curve (AUC) results. In a separate toxicology study, NS003 demonstrated a favorable safety profile at four times the test dose, with no adverse effects observed. With this milestone achieved, Nasus Pharma is now preparing to initiate a first-in-human PK study in the third quarter of 2026.

“These results represent a significant milestone for our pipeline programs as well as a further demonstration of the potential of our Nasax platform,” said Dan Teleman, Chief Executive Officer of Nasus Pharma. “Approximately 1 million patients in the United States receive chemotherapy annually, 60–80% of whom undergo highly or moderately emetogenic regimens, while an additional 800,000 patients undergo radiotherapy each year, with more than half experiencing radiotherapy-induced nausea and vomiting. Our market research indicates that 15–20% of these patients experience breakthrough nausea and vomiting not adequately controlled by oral therapies, often requiring a return to the clinic for intravenous anti-emetic treatment. Intranasal administration of NS003 has the potential to address this unmet need by offering a convenient, fast-onset alternative that may reduce avoidable clinic visits. We look forward to advancing NS003 to a first-in-human trial during the third quarter of 2026, followed by the pivotal study of NS002 for anaphylaxis in the fourth quarter of 2026, supporting the continued expansion of our intranasal product portfolio.”

About Nasus Pharma

Nasus Pharma is a clinical-stage pharmaceutical company developing a number of intranasal powder products addressing acute medical conditions in the community. NS002, Nasus Pharma’s intranasal powder Epinephrine product candidate is being developed as a needle-free alternative to Epinephrine autoinjectors for patients with anaphylaxis. Intranasal administration is most suitable for those situations in which rapid drug delivery is required and offers needle-free, easy-to-use alternatives. Nasus Pharma’s proprietary powder-based intranasal (“PBI”) technology is designed for rapid and reliable drug delivery, leveraging the nasal cavity’s rich vascular network for quick absorption. The PBI formulation uses uniform spherical powder particles for broad dispersion and potentially faster, higher absorption compared to liquid-based nasal products. For further information about the Company, please visit www.nasuspharma.com or follow on Twitter (X) or LinkedIn.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and other U.S. federal securities laws. Words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will”, “would,” or the negative of these words, similar expressions or variations of such words are intended to identify forward-looking statements. For example, Nasus Pharma is using forward-looking statements in this press release when it discusses: the planned initiation and timing of a first-in-human PK study and trial for NS003, the timing of the NS002 pivotal study, expected clinical and development milestones, and the expansion of the Company’s product portfolio. Historical results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. Forward-looking statements are based on the Company’s current expectations and are subject to uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in the Company’s Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on March 25, 2026. Forward-looking statements contained in this press release are made as of this date, and the Company undertakes no duty to update such information except as required under applicable law.

Corporate Contact
Nasus Pharma Ltd. Israel
info@nasuspharma.com

Investors Contact
Mike Moyer
LifeSci Advisors
+1-617-308-4306
mmoyer@lifesciadvisors.com


FAQ

What preclinical results did Nasus Pharma (NSRX) announce for intranasal ondansetron NS003 on June 9 2026?

Nasus Pharma announced positive preclinical pharmacokinetic and safety results for NS003, its intranasal ondansetron powder. According to Nasus Pharma, NS003 showed a pharmacokinetic profile comparable to intravenous ondansetron and a favorable safety profile in animal and toxicology studies, supporting advancement to human testing.

How does Nasus Pharma's NS003 intranasal ondansetron compare pharmacokinetically to intravenous ondansetron?

NS003 demonstrated a pharmacokinetic profile comparable to intravenous ondansetron in an animal study. According to Nasus Pharma, NS003 showed similar time to maximum concentration (Tmax) and area under the curve (AUC), suggesting intranasal delivery may achieve exposure levels comparable to IV administration in this preclinical model.

What safety data were reported for Nasus Pharma NS003 intranasal ondansetron?

NS003 showed a favorable safety profile in a separate toxicology study. According to Nasus Pharma, NS003 was tested at four times the test dose with no adverse effects observed, supporting further clinical development and the planned first-in-human pharmacokinetic study in the third quarter of 2026.

When will Nasus Pharma (NSRX) start the first-in-human study of intranasal ondansetron NS003?

Nasus Pharma plans to begin a first-in-human pharmacokinetic study of NS003 in the third quarter of 2026. According to Nasus Pharma, completion of positive preclinical PK and toxicology studies enables progression of this intranasal ondansetron candidate into initial human evaluation.

What unmet need could Nasus Pharma's NS003 intranasal ondansetron address for chemotherapy patients?

NS003 may address breakthrough nausea and vomiting not controlled by oral therapies in chemotherapy and radiotherapy patients. According to Nasus Pharma, 15–20% of such patients require clinic visits for IV anti-emetics, and intranasal NS003 could offer a convenient, fast-onset alternative.

What are Nasus Pharma's 2026 clinical plans for NS003 and NS002?

Nasus Pharma plans a first-in-human PK study of NS003 in Q3 2026 and a pivotal NS002 trial in Q4 2026. According to Nasus Pharma, NS003 targets nausea and vomiting, while NS002 is an intranasal candidate for anaphylaxis treatment.