Nasus Pharma Announces Approval from Health Canada to Initiate Planned Phase 2 Clinical Study of NS002 Intranasal Epinephrine Powder
Rhea-AI Summary
Nasus Pharma (NYSE: NSRX) received a No-Objection Letter from Health Canada on Nov 6, 2025, clearing the company to proceed with a planned Phase 2 clinical study of NS002, an investigational intranasal epinephrine powder for anaphylaxis.
The authorization confirms acceptability of the proposed trial design, provided safety data, and manufacturing information, and enables Nasus to advance toward initiating the Phase 2 study using its proprietary Nasax technology.
Positive
- Health Canada No-Objection Letter received on Nov 6, 2025
- Phase 2 trial authorization enables clinical advancement of NS002
- Regulatory acceptance of trial design, safety data, and manufacturing
Negative
- NS002 remains investigational; no Phase 2 initiation date provided
- No clinical efficacy or Phase 2 results reported yet
Positive Regulatory Response Marks Important Milestone for NS002 Development Program
TEL AVIV, Nov. 06, 2025 (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 that it recently received a No-Objection Letter from Health Canada, the country’s primary regulatory authority for drugs and medical products, for the Company’s planned Phase 2 clinical study of NS002, its investigational intranasal epinephrine powder formulation for the treatment of anaphylaxis.
The Health Canada authorization marks an important regulatory milestone in the NS002 development program. This clearance confirms the acceptability of the proposed trial design, supporting safety data, and manufacturing information, and enables Nasus to advance towards its planned Phase 2 clinical study.
"We believe receiving this approval from Health Canada represents an important milestone in our mission to transform anaphylaxis treatment," said Dan Teleman, Chief Executive Officer of Nasus Pharma. "For millions suffering from severe allergies, the fear of needles and inconvenience of carrying autoinjectors leads to poor compliance and potentially life-threatening outcomes. Our Phase 2 study aims to further evaluate how NS002, powered by our proprietary Nasax® technology, can deliver epinephrine effectively while offering patients the ease and convenience of a simple nasal spray. We look forward to initiating the study as soon possible.”
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’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 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. All statements, other than statements of historical fact, contained in this press release are forward-looking statements, including, among other things: statements regarding the initiation and outcomes of the Company’s planned Phase 2 clinical studies of NS002; its mission to transform anaphylaxis treatment; the potential for NS002 to address issues related to poor compliance with traditional autoinjectors due to needle fear and inconvenience; the capability of the Company’s proprietary Nasax® technology to deliver epinephrine effectively while offering a simple nasal spray alternative. Forward-looking statements contained in this press release may be identified by the use of 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 or other similar expressions, although not all forward-looking statements contain these words. 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
Arx Investor Relations
North American Equities Desk
nasus@arxhq.com
FAQ
What did Nasus Pharma announce about NS002 on Nov 6, 2025 (NSRX)?
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What is NS002 and how is it administered for anaphylaxis (NSRX)?
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Does the announcement include Phase 2 efficacy or safety results for NSRX?
