Nasus Pharma posts positive Phase 2 NS002 interim data
Nasus Pharma Ltd. reported positive interim results from its Phase 2 study of NS002, an intranasal epinephrine powder being developed to treat anaphylaxis.
Rhea-AI Filing Summary
Nasus Pharma Ltd. reported positive interim results from its Phase 2 study of NS002, an intranasal epinephrine powder being developed to treat anaphylaxis. In 25 evaluated participants, NS002 achieved a higher mean peak epinephrine plasma concentration of 655 pg/ml versus 548 pg/ml for EpiPen® and reached peak levels in 10.8 minutes compared with 15 minutes for EpiPen®.
Notably, 91% of participants given NS002 reached the 100 pg/ml epinephrine threshold at 5 minutes, versus 67% with EpiPen®, and early exposure over the first 10 minutes was higher with NS002 (AUC 55 h*pg/ml vs. 32 h*pg/ml). NS002 was well-tolerated in all 50 subjects who completed all treatment arms, with no serious adverse events and mostly mild, local effects, and its effects on blood pressure and pulse were comparable to EpiPen®. Nasus expects full Phase 2 results by the end of the first quarter of 2026 and plans to start a pivotal study in the fourth quarter of 2026.
Positive
- NS002 Phase 2 interim data show stronger early epinephrine exposure than EpiPen®, with 91% vs. 67% of participants reaching 100 pg/ml at 5 minutes and higher 10‑minute AUC (55 vs. 32 h*pg/ml), supporting advancement to a pivotal study in 2026.
Negative
- None.
Insights
Positive Phase 2 interim data support advancing NS002 into pivotal testing.
Nasus Pharma shared interim Phase 2 results for NS002, its intranasal epinephrine powder for anaphylaxis. NS002 showed faster and greater early epinephrine exposure than the intramuscular EpiPen® autoinjector, including a higher mean Cmax of 655 pg/ml versus 548 pg/ml and a shorter 10.8‑minute Tmax versus 15 minutes.
The data highlight early onset: 91% of NS002 recipients reached the 100 pg/ml plasma threshold at 5 minutes compared with 67% for EpiPen®, and 10‑minute exposure (AUC 55 h*pg/ml vs. 32 h*pg/ml) favored NS002. Repeat dosing, with and without nasal allergic challenge, maintained pharmacokinetic advantages, which is relevant because severe anaphylaxis may require multiple doses.
Safety looks favorable so far, with all 50 subjects completing all treatment arms, no serious adverse events, and mainly mild, self‑resolving local events. Hemodynamic responses were comparable to EpiPen® and stayed within normal ranges. The company plans to complete Phase 2 by the end of the first quarter of 2026 and initiate a pivotal study in the fourth quarter of 2026, making future clinical readouts key milestones for this program.
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What did Nasus Pharma (NSRX) report in this Form 6-K?
How did NS002 perform compared to EpiPen in the Phase 2 interim analysis?
What were the key early-exposure results for NS002 in Nasus Pharma's Phase 2 study?
What safety profile did NS002 show in the interim Phase 2 data for Nasus Pharma?
What are the next clinical milestones for NS002 according to Nasus Pharma?
What is NS002 and what condition is it intended to treat?
How does Nasus Pharma describe its intranasal powder technology?
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of January 2026
Commission File Number: 001-42796
Nasus Pharma Ltd.
Yigal Alon 65
Tel Aviv, Israel 6744317
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
CONTENTS
Press Release
On January 20, 2026, Nasus Pharma Ltd. (the “Company”) issued a press release titled “Nasus Pharma Announces Positive Interim Results from Phase 2 Clinical Study of NS002 Intranasal Epinephrine Powder,” a copy of which is furnished as Exhibit 99.1 to this Report of Foreign Private Issuer on Form 6-K.
Investor Presentation
On January 20, 2026, the Company made available an updated corporate presentation on its website. A copy of the corporate presentation is attached hereto as Exhibit 99.2 to this Report of Foreign Private Issuer on Form 6-K.
EXHIBIT INDEX
| Exhibit No. | Description | |
| 99.1 | Press Release issued on January 20, 2026 by Nasus Pharma Ltd. titled “Nasus Pharma Announces Positive Interim Results from Phase 2 Clinical Study of NS002 Intranasal Epinephrine Powder” | |
| 99.2 | Corporate Presentation, dated January 2026. |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| NASUS PHARMA LTD. | ||
| Date: January 20, 2026 | By: | /s/ Dan Teleman |
| Name: | Dan Teleman | |
| Title: | Chief Executive Officer | |
Exhibit 99.1
Nasus Pharma Announces Positive Interim Results from Phase 2 Clinical Study of NS002 Intranasal Epinephrine Powder
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, Israel, January 20, 2026 -- 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