Nasus Pharma Announces Positive Top Line Data from Phase 2 Clinical Study of NS002: Achieves Significantly Superior and Faster Epinephrine Delivery Compared to EpiPen® with Accelerated Speed to Therapeutic Threshold

Rhea-AI Summary

Nasus Pharma (NYSE: NSRX) reported positive Phase 2 top line results for intranasal epinephrine NS002, showing faster and higher early absorption versus EpiPen®.

Key outcomes: median T100 1.69 vs 3.42 minutes (p=0.033), 88.4% vs 64.6% reached 100 pg/mL at 5 minutes (p=0.0081), ~50% higher AUC in the 10-minute window, comparable Cmax, no serious adverse events. Pivotal study planned for Q4 2026.

Positive

• Median T100 1.69 min vs 3.42 min (p=0.033)
• 88.4% reached 100 pg/mL at 5 minutes vs 64.6%
• 67.4% vs 27.1% reached threshold at 2.5 minutes (p=0.0001)
• Approximately 50% higher AUC in first 10 minutes
• Median Tmax 15 min vs 19.8 min with EpiPen
• No serious adverse events reported

Negative

• None.

Market Reaction – NSRX

-44.00% $2.80 1773.5x vol

15m delay 77 alerts

-44.00% Since News

$2.80 Last Price

$2.73 $3.80 Day Range

-$26M Valuation Impact

$33M Market Cap

1773.5x Rel. Volume

Following this news, NSRX has declined 44.00%, reflecting a significant negative market reaction. Our momentum scanner has triggered 77 alerts so far, indicating high trading interest and price volatility. The stock is currently trading at $2.80. This price movement has removed approximately $26M from the company's valuation. Trading volume is exceptionally heavy at 1773.5x the average, suggesting significant selling pressure.

Data tracked by StockTitan Argus (15 min delayed). Upgrade to Silver for real-time data.

Key Figures

Median T100 NS002: 1.69 minutes Median T100 EpiPen: 3.42 minutes T100 p-value: p=0.033 +5 more

8 metrics

Median T100 NS002 1.69 minutes Time to 100 pg/mL epinephrine threshold vs EpiPen in Phase 2

Median T100 EpiPen 3.42 minutes Comparator time to 100 pg/mL epinephrine threshold

T100 p-value p=0.033 Statistical significance for median T100 difference

At 2.5 min NS002 67.4% of participants Reached 100 pg/mL threshold at 2.5 minutes

At 2.5 min EpiPen 27.1% of participants Reached 100 pg/mL threshold at 2.5 minutes

At 5 min NS002 88.4% of subjects Reached 100 pg/mL threshold at 5 minutes

At 5 min EpiPen 64.6% of subjects Reached 100 pg/mL threshold at 5 minutes

Phase 2 enrollment 50 healthy adults Open-label NS002 Phase 2 study population

Market Reality Check

Price: $5.00 Vol: Volume 5,882 is above the...

normal vol

$5.00 Last Close

Volume Volume 5,882 is above the 20-day average of 4,287, indicating elevated interest ahead of/around the data. normal

Technical Price at $5.00 is trading below the 200-day MA of $6.98 and well under the $9.99 52-week high.

Peers on Argus

NSRX is up 8.23% while the only peer in the momentum scanner (MDCX) is down ~2.4...

1 Down

NSRX is up 8.23% while the only peer in the momentum scanner (MDCX) is down ~2.44%, and other healthcare drug manufacturers show mixed moves, pointing to a stock-specific reaction.

Common Catalyst Both NSRX and peer MDCX have clinical trial-related headlines, but only NSRX appears in momentum with an upward move, suggesting company-specific interest in its NS002 Phase 2 data.

Previous Clinical trial Reports

3 past events · Latest: Mar 09 (Positive)

Same Type Pattern 3 events

Date	Event	Sentiment	Move	Catalyst
Mar 09	Phase 2 topline call	Positive	-15.4%	Scheduled webcast to present repeated-dose NS002 Phase 2 topline clinical data.
Jan 20	Interim Phase 2 data	Positive	-7.5%	Positive interim Phase 2 results showing faster absorption and higher exposure vs EpiPen.
Nov 06	Phase 2 clearance	Positive	-0.7%	Health Canada no‑objection letter clearing initiation of NS002 Phase 2 study.

Pattern Detected

Clinical trial announcements for NS002 have historically been followed by negative 1-day moves despite positive study updates.

Recent Company History

Over the last several months, Nasus Pharma has progressed NS002 from regulatory clearance to interim and then full Phase 2 results. A Nov 6, 2025 Health Canada no‑objection letter enabled the Phase 2 study. Positive interim data on Jan 20, 2026 and a Phase 2 topline presentation notice on Mar 9, 2026 were both followed by share price declines. Today’s detailed Phase 2 top line fits this clinical development arc toward a planned pivotal study in Q4 2026.

Historical Comparison

-7.9% avg move · In prior clinical-trial NS002 updates, NSRX averaged a -7.87% 1-day move. Today’s positive Phase 2 t...

clinical trial

-7.9%

Average Historical Move clinical trial

In prior clinical-trial NS002 updates, NSRX averaged a -7.87% 1-day move. Today’s positive Phase 2 topline and +8.23% move contrast with that pattern.

Same-tag events show NS002 advancing from Health Canada Phase 2 clearance, to positive interim Phase 2 data, to full Phase 2 topline ahead of a planned pivotal study in Q4 2026.

Market Pulse Summary

The stock is dropping -44.0% following this news. A negative reaction despite positive clinical data...

Analysis

The stock is dropping -44.0% following this news. A negative reaction despite positive clinical data would have fit the historical pattern, where NSRX averaged a -7.87% move on prior NS002 clinical-trial headlines. Even with faster time to therapeutic epinephrine levels and a clean safety profile, some investors might have focused on past financings or the long path to pivotal and regulatory stages. Such factors can weigh on sentiment despite seemingly strong Phase 2 outcomes.

Key Terms

anaphylaxis, pharmacokinetic, pharmacodynamic, tmax, +4 more

8 terms

anaphylaxis medical

"formulation for the treatment of anaphylaxis."

Anaphylaxis is a sudden, severe allergic reaction in which the body's defense system overreacts to a trigger (like a drug, food, or insect sting), causing widespread symptoms such as difficulty breathing, low blood pressure, and shock; it can be life‑threatening without prompt treatment. Investors care because anaphylaxis risks can affect a drug or product's safety profile, regulatory approval, liability exposure and market acceptance—similar to a sprinkler system going off and damaging the whole house rather than just one room.

pharmacokinetic medical

"multiple significant advantages for NS002 across key pharmacokinetic and pharmacodynamic parameters"

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.

pharmacodynamic medical

"multiple significant advantages for NS002 across key pharmacokinetic and pharmacodynamic parameters"

Pharmacodynamic describes how a drug acts on the body — the biological effects it produces, how strong those effects are, and how long they last. For investors, pharmacodynamic data show whether a treatment actually works and at what dose, shaping expectations about a drug’s safety, effectiveness, regulatory success and market potential; think of it like testing how well a key turns a lock and whether it reliably opens the door.

tmax medical

"NS002 reached peak concentration (“Tmax”) in a median of 15 minutes"

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.

cmax medical

"NS002 demonstrated comparable peak plasma concentration (“Cmax”) compared to EpiPen®"

Cmax is the highest concentration of a drug measured in the bloodstream after a dose, like the peak of a wave after a stone is dropped into water. It matters to investors because that peak helps regulators and doctors judge safety and likely effectiveness, informs dosing schedules, and is used to compare formulations or generics—data that can affect a drug’s approval, marketability, and commercial value.

auc medical

"with AUC statistically significantly higher in the first 5–10 minutes compared to EpiPen®."

Area under the curve (AUC) measures the total exposure of the body to a drug over time by calculating the area beneath a plot of drug concentration versus time. For investors, AUC indicates how much of a medicine reaches and stays in the bloodstream, which affects dosing, safety and effectiveness—similar to measuring how much water flows through a pipe over a day rather than just its peak pressure.

nasal allergic challenge medical

"with and without a nasal allergic challenge (“NAC”)."

A nasal allergic challenge is a controlled clinical test where a small, measured amount of an allergen is placed in the nose to provoke allergy symptoms and collect measurable biological responses. Investors care because it gives rapid, reliable evidence about whether a nasal treatment or diagnostic works and is safe—like a fire drill for a drug that reveals performance before larger, costlier trials—helping to de-risk development and inform regulatory and commercial decisions.

autoinjector medical

"compared to intramuscular EpiPen® autoinjector."

A prefilled, spring‑loaded medical device that automatically delivers a measured dose of medication beneath the skin when pressed against the body, like a self‑operating syringe packaged for quick use. Investors care because autoinjectors can increase patient safety, adherence and convenience — factors that drive demand, shape reimbursement and regulatory review, and affect a product’s market size, manufacturing complexity and competitive moat.

AI-generated analysis. Not financial advice.

NS002 demonstrated significantly faster time to the critical 100 pg/mL epinephrine threshold compared to EpiPen®, with a median T100 of 1.69 minutes versus 3.42 minutes (p=0.033). At 5 minutes, 88.4% of subjects receiving NS002 reached the threshold compared to 64.6% with EpiPen®

NS002 continued to demonstrate a favorable safety profile with no serious adverse events reported and comparable pharmacodynamic response to EpiPen® across all participants

Pivotal study initiation planned for fourth quarter of 2026

Conference call and webcast scheduled for 8:00 a.m. EDT today

TEL AVIV, Israel, March 16, 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 top line results from its Phase 2 clinical study of NS002, the Company's investigational intranasal epinephrine powder formulation for the treatment of anaphylaxis. The comprehensive analysis demonstrated that NS002 achieved significantly faster and higher early epinephrine absorption compared to intramuscular EpiPen® autoinjector. The Company plans to initiate its pivotal clinical study in fourth quarter of 2026.

The open-label Phase 2 study enrolled 50 healthy adults with a history of allergic rhinitis. All subjects received a single and repeat dose of NS002 and intramuscular EpiPen^® with and without a nasal allergic challenge (“NAC”). This robust study design provided comprehensive data supporting NS002's clinical utility across multiple administration scenarios that patients may encounter during actual anaphylactic emergencies.

"We've successfully demonstrated NS002's differentiated and potentially superior product profile compared to traditional epinephrine autoinjectors," said Dan Teleman, Chief Executive Officer of Nasus Pharma. "NS002 was specifically engineered for superior epinephrine delivery, powered by our proprietary Nasax® powder platform, and designed as a needle-free, easy to use and carry device. The compelling top line data significantly strengthens our conviction that NS002 has the potential to become a leading product in anaphylaxis treatment. These positive results represent a major milestone for Nasus Pharma as we advance NS002 towards the pivotal study and future marketing applications. We remain on track to initiate our pivotal study in the fourth quarter of 2026, bringing us closer to delivering this potentially life-saving innovation to patients worldwide."

Top Line Analysis Key Results:
The top line Phase 2 analysis demonstrated multiple significant advantages for NS002 across key pharmacokinetic and pharmacodynamic parameters:

• Speed to Therapeutic Threshold: After a single administration, NS002 achieved the critical 100 pg/mL plasma epinephrine threshold with a median T100 of 1.69 minutes versus 3.42 minutes for EpiPen® (p=0.033). At 2.5 minutes, 67.4% of participants receiving NS002 reached the therapeutic threshold compared to 27.1% with EpiPen® (p=0.0001). At 5 minutes, 88.4% of NS002 subjects reached the threshold compared to 64.6% with EpiPen® (p=0.0081). By 10 minutes, approximately 95% of participants receiving NS002 reached the therapeutic threshold.
  
  
• Time to Peak Concentration: NS002 reached peak concentration (“Tmax”) in a median of 15 minutes compared to 19.8 minutes with EpiPen®, demonstrating consistently faster epinephrine delivery.
  
  
• Critical Window Drug Exposure: Total epinephrine absorption in the critical 10-minute therapeutic window following administration was approximately 50% higher with NS002, with AUC statistically significantly higher in the first 5–10 minutes compared to EpiPen®.
  
  
• Repeat Dose Performance: Repeat administration of NS002 with or without a NAC maintained consistent pharmacokinetic advantages over EpiPen®, a clinically significant finding given that patients experiencing severe anaphylaxis may require a repeat dose to fully resolve symptoms.
  
  
• Peak Plasma Concentrations: Across multiple scenarios, NS002 demonstrated comparable peak plasma concentration (“Cmax”) compared to EpiPen®, with repeat dosing showing particularly strong performance.

• Safety and Tolerability Profile: NS002 demonstrated a favorable safety and tolerability profile consistent with previous studies, with no serious adverse events reported.

These results demonstrated that NS002 has the potential to exceed EpiPen® performance across the full spectrum of real-world conditions, including the challenging NAC environment that simulates scenarios patients may encounter during actual allergic reactions. The analysis showed statistically significant improvements in time to therapeutic threshold (T100) and in the proportion of subjects reaching the therapeutic epinephrine threshold within the first minutes following administration.

Conference call and webcast
Nasus Pharma will host a conference call and webcast today at 8:00 a.m. EDT to review and discuss the final analysis data from the Phase 2 repeated dose clinical study. Individuals may dial in to the conference call by dialing 1-877-704-4453 from the U.S. or by dialing +1-201-389-0920 from outside the U.S., or view the webcast HERE. A replay of the webcast will be hosted on Nasus Pharma’s investor relations website at https://ir.nasuspharma.com/investors/events/.

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 belief that the full analysis from the Phase 2 clinical study demonstrates NS002’s superior epinephrine delivery compared to traditional epinephrine autoinjectors; the belief that NS002 has the potential to become a leading product in anaphylaxis treatment; the expectation that the top line data from the Phase 2 study will support advancement of NS002 toward a pivotal study and future marketing applications; the potential of NS002 to exceed EpiPen® performance across the full spectrum of real-world conditions, including the challenging NAC environment that simulates scenarios patients may encounter during actual allergic reactions  and, the timing of initiating its pivotal clinical study in the fourth quarter of 2026.  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 Registration Statement on Form F-1 filed with the U.S. Securities and Exchange Commission on March 2, 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.

Company Contact
Nasus Pharma Ltd.
info@nasuspharma.com

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

FAQ

What did Nasus Pharma (NSRX) report in the March 16, 2026 Phase 2 NS002 results?

NS002 showed significantly faster epinephrine absorption than EpiPen, reaching T100 in 1.69 minutes. According to the company, NS002 had higher early AUC (~50% in 10 minutes), comparable Cmax, and no serious adverse events, supporting a Q4 2026 pivotal study start.

How much faster was NS002 compared to EpiPen in reaching therapeutic epinephrine levels?

NS002 reached the 100 pg/mL threshold in a median 1.69 minutes versus 3.42 minutes for EpiPen. According to the company, a higher proportion hit the threshold early (67.4% at 2.5 minutes, 88.4% at 5 minutes), with statistical significance.

What safety results did Nasus Pharma (NSRX) report for NS002 on March 16, 2026?

NS002 demonstrated a favorable safety profile with no serious adverse events reported in Phase 2. According to the company, tolerability matched prior studies and pharmacodynamic responses were comparable to EpiPen across participants.

Will Nasus Pharma (NSRX) move NS002 into a pivotal study and when?

The company plans to initiate a pivotal clinical study in the fourth quarter of 2026. According to the company, the Phase 2 top line data support advancing NS002 toward the planned pivotal study and future regulatory submissions.

Did NS002 maintain performance on repeat dosing in the Phase 2 trial?

Yes — NS002 maintained consistent pharmacokinetic advantages on repeat dosing with or without nasal allergic challenge. According to the company, this finding is clinically relevant because repeat doses may be needed during severe anaphylaxis.

How did NS002 perform under nasal allergic challenge compared to EpiPen in the Phase 2 study?

NS002 continued to show faster early absorption and higher early AUC even with a nasal allergic challenge. According to the company, results suggest NS002 performs well across real-world administration scenarios that simulate allergic reactions.