Nasus Pharma Announces Approval from Health Canada to Initiate Planned Phase 2 Clinical Study of NS002 Intranasal Epinephrine Powder
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.
Nasus Pharma (NYSE: NSRX) ha ricevuto una Lettera di non obiezione da Health Canada il 6 novembre 2025, permettendo all'azienda di procedere con un trattamento di Fase 2 dello NS002, una polvere di epinefrina intranasale sperimentale per l'anafilassi.
L'autorizzazione conferma l'accettabilità del design proposto dello studio, a condizione che siano disponibili dati di sicurezza e informazioni sulla produzione, e consente a Nasus di avanzare verso l'inizio dello studio di Fase 2 utilizzando la sua tecnologia proprietaria Nasax.
Nasus Pharma (NYSE: NSRX) recibió una Carta de No Objection de Health Canada el 6 de noviembre de 2025, lo que autoriza a la empresa a continuar con un ensayo clínico de Fase 2 de NS002, un polvo de epinefrina intranasal en investigación para la anafilaxia.
La autorización confirma la aceptabilidad del diseño propuesto del ensayo, siempre que se cuenten con datos de seguridad e información de fabricación, y permite a Nasus avanzar hacia el inicio del estudio de Fase 2 utilizando su tecnología propietaria Nasax.
Nasus Pharma (NYSE: NSRX)은 2025년 11월 6일 Health Canada로부터 No-Objection Letter를 받아 회사가 계획된 NS002의 2상 임상시험을 진행할 수 있게 되었으며, 이는 아나필락시스용으로 연구 중인 비강 내 에피네프린 분말입니다.
이 승인은 제안된 시험 설계의 수용성을 안전성 데이터 및 제조 정보를 충족하는 조건 하에 확인하며, Nasus가 고유 기술인 Nasax 기술을 사용하여 2상 연구를 시작할 수 있도록 허용합니다.
Nasus Pharma (NYSE: NSRX) a reçu le Lettre d’absence d’objection (No-Objection Letter) de Santé Canada le 6 novembre 2025, autorisant l’entreprise à poursuivre une étude clinique de phase 2 de NS002, une poudre d’épinéphrine intranasale expérimentale pour l’anaphylaxie.
L’autorisation confirme l’acceptabilité du design proposé de l’essai, sous réserve que les données de sécurité et les informations de fabrication soient disponibles, et permet à Nasus d’avancer vers le démarrage de l’étude de phase 2 en utilisant sa technologie propriétaire Nasax.
Nasus Pharma (NYSE: NSRX) erhielt am 6. November 2025 ein No-Objection Letter von Health Canada, das dem Unternehmen die Durchführung einer geplanten Phase-2-Studie von NS002 erlaubt, einem experimentellen intranasalen Epinephrin-Pulver zur Behandlung von Anaphylaxie.
Die Genehmigung bestätigt die Akzeptabilität des vorgeschlagenen Studien-Designs, vorausgesetzt Sicherheitsdaten und Herstellungsinformationen liegen vor, und ermöglicht Nasus, sich darauf vorzubereiten, die Phase-2-Studie unter Verwendung seiner proprietären Nasax-Technologie zu beginnen.
Nasus Pharma (NYSE: NSRX) تلقت خطاب عدم الاعتراض من هيئـة الصحة الكندية في 6 نوفمبر 2025، مما يسمح للشركة بالمضي قدماً في تجربة المرحلة الثانية المخطط لها لـ NS002، وهي مسحوق إبينفرين عبر الأنف للاستخدام في حالات فرط التحسس (الأنفلونزا؟ تم التعديل لتكون للحساسية المفرطة).
الترخيص يؤكد قبول تصميم الدراسة المقترح بشرط أن تكون هناك بيانات السلامة ومعلومات التصنيع، ويسمح لـ Nasus بالتقدم نحو بدء دراسة المرحلة 2 باستخدام تقنيتها الملكية Nasax.
- 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
- 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
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