Nasus Pharma Announces Positive Interim Results from Phase 2 Clinical Study of NS002 Intranasal Epinephrine Powder

Rhea-AI Summary

Nasus Pharma (NYSE: NSRX) reported positive interim Phase 2 results for NS002, an intranasal epinephrine powder. The open-label study enrolled 50 healthy adults with allergic rhinitis. Key pharmacokinetic advantages versus intramuscular EpiPen®: Cmax 655 pg/ml vs 548 pg/ml, Tmax 10.8 min vs 15 min, and 91% vs 67% of participants reached the 100 pg/ml plasma threshold at 5 minutes. Early exposure (AUC 0–10 min) was 55 h*pg/ml vs 32 h*pg/ml. Repeat dosing with or without nasal allergic challenge showed consistent PK benefits. Safety: NS002 was well-tolerated with no serious adverse events and mostly mild, local TEAEs. Full Phase 2 results expected by end of Q1 2026; pivotal study planned for Q4 2026.

Positive

• Cmax 655 pg/ml for NS002 versus 548 pg/ml for EpiPen
• Tmax faster at 10.8 minutes versus 15 minutes for EpiPen
• 91% of NS002 subjects reached 100 pg/ml at 5 minutes versus 67% with EpiPen
• Early exposure (AUC 0–10 min) higher at 55 h*pg/ml versus 32 h*pg/ml
• No serious adverse events reported across 50 subjects; mostly mild local TEAEs
• Consistent pharmacokinetic advantages on repeat dosing with or without nasal challenge

Negative

• Results are interim and based on an open-label study; full Phase 2 data pending end of Q1 2026
• Study population was healthy adults with allergic rhinitis, not patients experiencing anaphylaxis
• Small sample size of 50 subjects limits broad generalizability

News Market Reaction

-7.52%

1 alert

-7.52% News Effect

-$5M Valuation Impact

$64M Market Cap

0.7x Rel. Volume

On the day this news was published, NSRX declined 7.52%, reflecting a notable negative market reaction. This price movement removed approximately $5M from the company's valuation, bringing the market cap to $64M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Participants reaching 100 pg/ml at 5 min (NS002): 91% Participants reaching 100 pg/ml at 5 min (EpiPen): 67% Phase 2 enrollment: 50 healthy adults +5 more

8 metrics

Participants reaching 100 pg/ml at 5 min (NS002) 91% Phase 2 interim pharmacokinetic threshold response vs EpiPen

Participants reaching 100 pg/ml at 5 min (EpiPen) 67% Comparator arm in Phase 2 interim analysis

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

NS002 Cmax 655 pg/ml Mean peak plasma epinephrine concentration vs 548 pg/ml for EpiPen

NS002 Tmax 10.8 minutes Time to peak plasma concentration vs 15 minutes for EpiPen

NS002 AUC (0–10 min) 55 h*pg/ml Total epinephrine exposure in first 10 minutes vs 32 h*pg/ml for EpiPen

Mild treatment-emergent AEs 95% Proportion of TEAEs that were mild and self-resolving

Phase 2 completion target End of Q1 2026 Expected timing for full Phase 2 NS002 results

Market Reality Check

Price: $6.25 Vol: Volume 4,236 is about 45%...

low vol

$6.25 Last Close

Volume Volume 4,236 is about 45% of the 9,391 share 20-day average, indicating limited pre-news activity. low

Technical Shares at $7.05 are trading below the 200-day MA of $7.56 and 29.43% under the 52-week high.

Peers on Argus

NSRX showed a modest -0.7% move pre-news with low volume, while only one scanned...

1 Up

NSRX showed a modest -0.7% move pre-news with low volume, while only one scanned peer, RMTI, appeared in momentum data, up 18.04% without news. Broader drug manufacturer peers showed mixed, stock-specific moves.

Historical Context

5 past events · Latest: 2025-12-22 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
2025-12-22	Shareholder letter	Positive	-6.6%	Outlined 2025 milestones, IPO proceeds use, and NS002 development timelines.
2025-10-08	Partnership expansion	Positive	+0.8%	Expanded Aptar agreements to support NS002 device, supply and regulatory work.
2025-09-02	Conference participation	Neutral	-0.7%	Announced virtual presentation at H.C. Wainwright investor conference.
2025-08-26	Listing milestone	Positive	+0.5%	Celebrated NYSE American listing with bell ceremony highlighting NS002 focus.
2025-08-14	IPO financing	Positive	+0.6%	Closed IPO raising $10M to fund NS002 development and corporate needs.

Pattern Detected

Recent news often saw modest reactions, with one notable divergence where a positive shareholder letter coincided with a larger one-day decline.

Recent Company History

Over the past six months, Nasus Pharma advanced NS002 and its corporate profile with an IPO in August 2025 raising $10 million, NYSE American listing, and expanded Aptar collaboration to support NS002 development and commercialization. Subsequent updates included conference participation and a 2025 shareholder letter outlining Phase 2 progress and timelines. That letter highlighted the interim analysis now reported, linking today’s Phase 2 interim results to previously signposted milestones and the broader NS002 development strategy.

Market Pulse Summary

The stock moved -7.5% in the session following this news. A negative reaction despite favorable Phas...

Analysis

The stock moved -7.5% in the session following this news. A negative reaction despite favorable Phase 2 interim data would contrast with prior largely aligned responses to positive corporate events such as the $10 million IPO and Aptar collaboration expansion. The market may reassess execution risk, timelines to the planned pivotal study in late 2026, or the open-label design despite strong pharmacokinetics. Historical patterns show that one positive shareholder update coincided with a -6.56% move, suggesting good news has not always translated into near-term price strength.

Key Terms

phase 2, cmax, tmax, auc, +4 more

8 terms

phase 2 medical

"positive interim results from its Phase 2 clinical study of NS002"

Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

cmax medical

"higher mean peak plasma concentration (“Cmax”) of 655 pg/ml compared to 548 pg/ml"

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.

tmax medical

"achieved peak concentration (“Tmax”) in 10.8 minutes compared to 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.

auc medical

"higher in participants administered NS002 (AUC: 55 h*pg/ml) 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.

pharmacokinetic medical

"Repeat administration of NS002 ... demonstrated consistent pharmacokinetic advantages"

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

"The pharmacodynamic response, including changes from baseline in systolic and diastolic"

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.

anaphylaxis medical

"formulation for the treatment of anaphylaxis. The data demonstrated that NS002 achieved"

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.

pivotal study medical

"Pivotal study initiation planned for fourth quarter of 2026"

A pivotal study is a large, definitive clinical trial designed to show whether a medical product works and is safe enough for regulators to approve and for doctors to use. Think of it as the final exam that determines whether a drug or device moves from testing into the market; its results can dramatically change a company’s approval chances, future sales prospects, and therefore its stock value.

AI-generated analysis. Not financial advice.

Interim results indicate NS002 demonstrated significantly faster absorption and higher peak epinephrine levels compared to EpiPen^®

91% of study participants achieved the 100 pg/ml plasma threshold at 5 minutes with NS002 compared to 67% with EpiPen^®  

NS002 was well-tolerated with no serious adverse events reported, and a pharmacodynamic response comparable to EpiPen^®

Full Phase 2 results expected by the end of first quarter of 2026; Pivotal study initiation planned for fourth quarter of 2026

TEL AVIV, Jan. 20, 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 to treat emergency medical conditions, today announced positive interim results from its Phase 2 clinical study of NS002, the Company's investigational intranasal epinephrine powder formulation for the treatment of anaphylaxis. The data demonstrated that NS002 achieved faster absorption, higher peak concentrations, and greater early epinephrine exposure compared to intramuscular EpiPen^® autoinjector.

The open-label Phase 2 study enrolled 50 healthy adults with a history of allergic rhinitis across two cohorts.  At the interim analysis, the first cohort of 25 participants received NS002 or intramuscular EpiPen^® with and without a nasal allergic challenge. The second cohort of 25 participants received repeat doses of NS002 or intramuscular EpiPen^® with and without a nasal allergic challenge, evaluating real-world scenarios where multiple administrations may be necessary. The final analysis will include results of all 50 subjects who will have received all treatments.

Key Interim Results:

NS002 demonstrated a higher mean peak plasma concentration (“Cmax”) of 655 pg/ml compared to 548 pg/ml for EpiPen^®, and achieved peak concentration (“Tmax”) in 10.8 minutes compared to 15 minutes with EpiPen^®. Critically, 91% of participants administered NS002 reached the epinephrine plasma threshold of 100 pg/ml at 5 minutes, compared to 67% of those administered EpiPen^®. Total epinephrine absorption in the 10 minute period following administration—the critical window for resolving anaphylaxis—was higher in participants administered NS002 (AUC: 55 h*pg/ml) compared to EpiPen^® (AUC: 32 h*pg/ml).

Repeat administration of NS002 with or without nasal allergic challenge demonstrated consistent pharmacokinetic advantages over EpiPen^®. This is a clinically relevant finding, as patients experiencing severe anaphylaxis may require repeat doses to fully resolve symptoms.

The interim analysis includes safety data on all 50 subjects who completed all treatment arms. NS002 was well-tolerated, with no serious adverse events reported. The majority (95%) of treatment-emergent adverse events were mild and self-resolving, mostly local.  

The pharmacodynamic response, including changes from baseline in systolic and diastolic blood pressure and pulse rate, was comparable to that of EpiPen^® and remained within the normal range.

"We believe these interim results are highly encouraging and reinforce the potential of NS002 as a meaningful advancement in anaphylaxis treatment," said Dr. Michael Blaiss, Clinical Professor of Allergy and Immunology at the Medical College of Georgia at Augusta University and member of Nasus Pharma's Scientific Advisory Board. "The interim data demonstrated that NS002 delivered epinephrine to the bloodstream faster and achieved higher concentrations than an intramuscular autoinjector. In anaphylaxis, outcomes are highly time-dependent, and delays in achieving effective pharmacologic action are associated with increased mortality. These pharmacokinetic advantages, combined with the needle-free administration, could help address the significant compliance challenges we see with current treatments."

"We are extremely pleased with these positive interim results, which we believe further validate NS002's potential as a first-in-class intranasal powder epinephrine product for patients with severe allergies," said Dan Teleman, Chief Executive Officer of Nasus Pharma. "The sustained performance of NS002 across single and repeat dosing scenarios – including under conditions simulating real-world allergic reactions – demonstrates the robustness of our proprietary Nasax^® platform technology. We look forward to completing the Phase 2 study and advancing to our pivotal clinical program."

Nasus Pharma expects to complete the Phase 2 study by the end of the first quarter of 2026. The Company plans to initiate its pivotal clinical study in fourth quarter of 2026.

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’ 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’ 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 is using forward looking statements in this press release when it discusses the belief that the interim data from the Phase 2 clinical study are highly encouraging and reinforce the potential of NS002 as a meaningful advancement in anaphylaxis treatment, the timing of the completion of its Phase 2 study, and the timing of initiating its pivotal clinical study.  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 prospectus filed with the U.S. Securities and Exchange Commission dated August 12, 2025. 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 interim Phase 2 results did Nasus Pharma (NSRX) report for NS002 on January 20, 2026?

NS002 showed faster absorption and higher peak levels versus EpiPen: Cmax 655 pg/ml, Tmax 10.8 min, and 91% reached 100 pg/ml at 5 minutes.

How did NS002 perform compared to EpiPen in early epinephrine exposure in the NSRX Phase 2 interim data?

Early exposure (AUC 0–10 min) was higher for NS002 at 55 h*pg/ml versus 32 h*pg/ml for EpiPen.

What safety findings did Nasus Pharma report for NS002 in the interim Phase 2 analysis?

NS002 was reported as well-tolerated with no serious adverse events and mostly mild, self-resolving local treatment-emergent adverse events.

When will Nasus Pharma (NSRX) complete Phase 2 and start a pivotal study for NS002?

The company expects to complete Phase 2 by the end of Q1 2026 and to initiate a pivotal study in Q4 2026.

How many subjects were included in the NS002 Phase 2 interim analysis and what population was studied?

The interim analysis included data from 50 healthy adults with a history of allergic rhinitis across two cohorts.

Did NS002 show consistent results on repeat dosing in the NSRX Phase 2 study?

Yes; repeat administration with or without a nasal allergic challenge demonstrated consistent pharmacokinetic advantages over EpiPen.