Nasus Pharma Announces FDA Clearance to Initiate Clinical Study of NS002 in the Treatment of Anaphylaxis

FDA IND clearance enables Nasus Pharma to advance intranasal epinephrine candidate NS002 toward a pivotal study in a $2 billion anaphylaxis market.

Rhea-AI Summary

Nasus Pharma (NSRX) received U.S. FDA clearance of its Investigational New Drug (IND) application for NS002, an investigational intranasal epinephrine powder for the treatment of anaphylaxis. The IND clearance allows initiation of a clinical study evaluating NS002 as a needle-free alternative to EpiPen, including comparison of self-administration by patients to administration by a health care professional.

In addition to the cleared study, Nasus Pharma plans to start a pivotal NS002 study in the fourth quarter of 2026 and anticipates topline data in the first quarter of 2027. The company cites a recent Phase 2 study in which NS002 achieved the critical 100 pg/mL plasma epinephrine threshold with a median T100 of 1.69 minutes versus 3.47 minutes for EpiPen. Nasus Pharma describes NS002 as targeting a growing $2 billion market for treatments of severe allergic reactions currently dominated by injectable autoinjectors.

Positive

• FDA cleared NS002 IND, enabling U.S. clinical study initiation
• Planned pivotal NS002 study start in Q4 2026 with topline data in Q1 2027
• Phase 2 NS002 median T100 1.69 minutes vs EpiPen 3.47 minutes at 100 pg/mL threshold
• NS002 targets a growing anaphylaxis treatment market of about $2 billion

Negative

• None.

Argus 15 min delay

+6.61% vs previous close $3.63 last price 0.2x rel. volume Open Argus

Details

Market reaction after FDA IND clearance: NSRX +6.61%

$3.63 $3.63 Day Range

$42.52M Market Cap

Following this news, NSRX has gained 6.61%, reflecting a notable positive market reaction. The stock is currently trading at $3.63.

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

Market Context

The Aug 17 NS002 update recorded a 2.21% 24-hour move and reported positive Phase 2 findings, a dire...

Analysis

The Aug 17 NS002 update recorded a 2.21% 24-hour move and reported positive Phase 2 findings, a directly related prior program milestone. The current FDA IND clearance advanced NS002 toward its planned pivotal study.

Key Figures

Pivotal study timing: Q4 2026 Topline data timing: Q1 2027 Plasma epinephrine threshold: 100 pg/mL +2 more

Pivotal study timing

Q4 2026

NS002 anaphylaxis study

Topline data timing

Q1 2027

NS002 pivotal study

Plasma epinephrine threshold

100 pg/mL

Recent Phase 2 study

Median T100

1.69 minutes vs. 3.47 minutes

NS002 versus EpiPen in recent Phase 2 study

Anaphylaxis market

$2 billion

Market referenced by company

Historical Context

1 past event · Latest: Aug 17

1 event

1. Aug 17

   Phase 2 clinical update

   24h Move

   +2.2%

   Reported statistically significant Phase 2 improvement and planned pivotal study for Q4 2026

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

Key Terms

investigational new drug, pivotal study, anaphylaxis

3 terms

investigational new drug regulatory

"the U.S. Food and Drug Administration (“FDA”) has cleared the Company's Investigational New Drug"

An investigational new drug is a medication that is still being tested in clinical trials to determine if it is safe and effective for treating a specific condition. For investors, it represents a potential breakthrough that could lead to a new treatment and significant financial gains if successful, but also carries risks since it has not yet been approved for widespread use.

pivotal study medical

"Nasus Pharma plans to initiate its pivotal study in the 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.

anaphylaxis medical

"NS002, its investigational intranasal epinephrine powder 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.

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

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Clinical study to evaluate NS002, the Company's investigational intranasal epinephrine powder, as a needle-free alternative to EpiPen® for patients experiencing anaphylaxis and will compare self-administration to administration by a health care professional

Pivotal Study is planned for the fourth quarter of 2026; topline data readout anticipated first quarter 2027

TEL AVIV, Israel, Sept. 14, 2026 (GLOBE NEWSWIRE) -- Nasus Pharma Ltd. (NYSE American: NSRX) (“Nasus Pharma” or the “Company”), a clinical-stage pharmaceutical company focused on the development of innovative intranasal products, today announced that the U.S. Food and Drug Administration (“FDA”) has cleared the Company's Investigational New Drug (“IND”) application for NS002, its investigational intranasal epinephrine powder for the treatment of anaphylaxis. In addition to the current study approved in the IND, Nasus Pharma plans to initiate its pivotal study in the fourth quarter of 2026 and anticipates topline data readout from the study in the first quarter of 2027.

“FDA clearance of our IND for NS002 is a major development milestone for Nasus and represents a significant step toward the commercialization of this promising asset in a growing $2 billion market,” said Brendan O'Grady, Chief Executive Officer of Nasus Pharma. “Patients living with severe allergies today rely almost exclusively on needle-based autoinjectors. Based on the results from our recent Phase 2 study, which showed NS002 achieving the critical 100 pg/mL plasma epinephrine threshold with a median T100 of 1.69 minutes versus 3.47 minutes for EpiPen®, we believe NS002 presents an opportunity to address a significant unmet medical need for these patients. In a market currently dominated by injectables, NS002’s rapid onset and intranasal administration offer patients and caregivers a potentially superior alternative for treating severe allergic reactions. FDA clearance of our IND application brings us one step closer to offering that alternative to the millions of people at risk of anaphylaxis.”

About Nasus Pharma

Nasus Pharma Ltd. (NYSE American: NSRX) is a biopharmaceutical company advancing innovative intranasal therapies through its proprietary intranasal powder technology platform. The Company's lead product candidate, NS002, is being developed as an intranasal epinephrine treatment for Type I allergic reactions, including anaphylaxis. In addition to NS002, Nasus Pharma is leveraging its proprietary technology platform to develop a growing pipeline of differentiated intranasal product candidates designed to provide rapid, reliable and patient-friendly drug delivery across multiple therapeutic areas.

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 of its pivotal clinical study for NS002 in the fourth quarter of 2026; the anticipation of topline data readout to be in the first quarter of 2027; the growing market for anaphylaxis treatment; and that FDA clearance of the Company’s IND application brings it one step closer to offering a needle-free alternative to millions of people at risk of anaphylaxis. Forward-looking statements are based on the Company's current expectations and are subject to uncertainties, risks and assumptions that are difficult to predict, including the risk that the FDA may require additional information or studies before or after the pivotal study, that the pivotal study may not begin or conclude on the timeline the Company currently expects, and that results of the pivotal study may not support further development or approval of NS002. 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.  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 for the year ended December 31, 2025, filed with the U.S. Securities and Exchange Commission (“SEC”) on March 25, 2026, and other documents filed with or furnished to the SEC which are available on the SEC’s website, www.sec.gov. 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

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What is NS002 and how is it intended to be used?

NS002 is Nasus Pharma's lead product candidate, an investigational intranasal epinephrine powder being developed for the treatment of Type I allergic reactions, including anaphylaxis. It is designed as a needle-free alternative to injectable autoinjectors, potentially allowing patients and caregivers to administer epinephrine intranasally during severe allergic reactions.

What will the cleared clinical study of NS002 evaluate?

The cleared clinical study will evaluate NS002 as a needle-free alternative to EpiPen for patients experiencing anaphylaxis. It will compare self-administration of NS002 by patients to administration by a health care professional, assessing its use in real-world emergency treatment scenarios.

What prior clinical data on NS002 did Nasus Pharma highlight?

Nasus Pharma highlighted a recent Phase 2 study in which NS002 achieved the critical 100 pg/mL plasma epinephrine threshold. In that study, NS002 showed a median T100 of 1.69 minutes compared with 3.47 minutes for EpiPen, supporting the company's view of NS002 as a rapid-onset treatment option.