Nasus Pharma（NSRX）获FDA批准启动NS002鼻喷肾上腺素治疗过敏反应的临床研究

----- form6-k.htm -----
6-K
1
form6-k.htm
6-K
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 September 2026 (Report No. 2)
Commission
File Number: 001-42796
Nasus
Pharma Ltd.
P.O.
Box 284
Tel
Aviv, Israel 6100201
(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
On
September 14, 2026, Nasus Pharma Ltd. (the “Company”) issued a press release titled “Nasus Pharma Announces FDA Clearance
to Initiate Clinical Study of NS002 in the Treatment of Anaphylaxis,” a copy of which is furnished as Exhibit 99.1 to this Report
of Foreign Private Issuer on Form 6-K.
Incorporation
by Reference
This
Report of Foreign Private Issuer on Form 6-K (excluding the second paragraph of the press release included as Exhibit 99.1 hereto) is
incorporated by reference into the Company’s Registration Statements on Form F-3 (File No.
333-298693
) and Form S-8 (File No.
333-296252
)
filed with the Securities and Exchange Commission to be a part thereof from the date on which this Report of Foreign Private Issuer on
Form 6-K is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.
EXHIBIT
INDEX
Exhibit
No.
Description
99.1
Press Release dated September 14, 2026 titled “Nasus Pharma Announces FDA Clearance to Initiate Clinical Study of NS002 in the Treatment of Anaphylaxis”
2
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:
September 14, 2026
By:
/s/
Brendan O’Grady
Name:
Brendan
O’Grady
Title:
Chief
Executive Officer
3

----- ex99-1.htm -----
EX-99.1
2
ex99-1.htm
EX-99.1
Exhibit 99.1
Nasus
Pharma Announces FDA Clearance to Initiate Clinical Study of NS002 in the Treatment of Anaphylaxis
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, September 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