NEW YORK, May 28, 2023 (GLOBE NEWSWIRE) — Pomerantz LLP is investigating claims on behalf of investors of ARS Pharmaceuticals, Inc. (“ARS” or the “Company”) WARM. Such investors are advised to contact Robert S. Willoughby at newaction@pomlaw.com or 888-476-6529, extension 7980.

The investigation concerns whether ARS and certain of its officers and/or directors have engaged in securities fraud or other illegal business practices.

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On May 9, 2023, ARS issued a press release titled “announc[ing] . . . that the U.S. Food and Drug Administration (FDA) has released briefing documents for the Pulmonology, Allergy-Drugs Advisory Committee (PADAC) meeting to review the new drug application (NDA). neffy^®.” The FDA’s briefing documents raised concerns, stating: “[e]Establishing efficacy based on PK/PD similarity to approved epinephrine injection products is due to the paucity and variability of PK/PD data for epinephrine injections and the uncertainties in extrapolating PK/PD results from a topically administered Drug challenge from healthy subjects to patients with anaphylaxis Changes in nasal mucosa may impair absorption”; and that “[b]Given the severity of the indication and the availability of approved safe and effective products, we must have confidence that the efficacy and safety of adrenaline administered through this novel route of administration has been demonstrated. Residual uncertainties should be minimized.”

As a result of this news, ARS’ stock price fell $0.86 per share, or 14.31%, to close at $5.15 per share on May 9, 2023.

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