SEC Form 8-K filed by ARS Pharmaceuticals Inc.
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| Item 8.01 | Other Events. |
FDA Approval of neffy® 1 mg (epinephrine nasal spray)
On March 5, 2025, ARS Pharmaceuticals, Inc. (the “Company”) announced that the U.S. Food and Drug Administration (“FDA”) approved neffy 1 mg (epinephrine nasal spray) for the emergency treatment of allergic reactions (Type I), including anaphylaxis, in children who are aged four years and older and weigh ≥15 kilograms to <30 kilograms (≥33lbs. to <66 lbs.).
The approval of neffy 1 mg is based on data from multiple clinical trials, including pharmacokinetic and pharmacodynamic responses in subjects that were consistent with those of epinephrine injection products. Adverse events in pediatric trials were generally mild and transient. Human factor studies also show children as young as ten, as well as untrained individuals such as babysitters or teachers, can effectively administer neffy 1 mg by following instructions.
neffy 1 mg is expected to be available in the U.S. by the end of May 2025 for patients who are aged four years and older and weigh ≥15 kilograms to <30 kilograms (≥33lbs. to <66 lbs.).
The approval of neffy 1 mg follows FDA approval for neffy 2 mg on August 9, 2024 for children and adults weighing ≥30kg (≥66 lbs.), and approval for EURneffy (the tradename neffy in the E.U.) by the European Commission on August 22, 2024.
Forward-Looking Statements
This report contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, the timeline for neffy 1 mg’s commercial availability; and other statements that are not historical fact. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon the Company’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the ability to maintain regulatory approval for neffy; and complications associated with supply and distribution. Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, filed with the SEC on November 13, 2024.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| ARS PHARMACEUTICALS, INC. | ||||||
| Date: March 5, 2025 | By: | /s/ Richard Lowenthal | ||||
| Richard Lowenthal, M.S., MBA | ||||||
| President and Chief Executive Officer | ||||||