NEW YORK, May 28, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of ARS Pharmaceuticals, Inc. (“ARS” or the “Company”) (NASDAQ: SPRY). Such investors are advised to contact Robert S. Willoughby at newaction@pomlaw.com or 888-476-6529, ext. 7980.
The investigation concerns whether ARS and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
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On May 9, 2023, ARS issued a press release “announc[ing] . . . that the U.S. Food and Drug Administration (FDA) posted briefing documents for the Pulmonology, Allergy-Drugs Advisory Committee (PADAC) meeting to review the new drug application (NDA) for neffy®.” The FDA briefing documents expressed concerns, stating that “[e]stablishing efficacy based on PK/PD similarity to approved epinephrine injection products is challenging due to the paucity and variability of PK/PD data for epinephrine injection and uncertainties in translating PK/PD results of a topically administered drug from healthy subjects to patients with anaphylaxis where nasal mucosal changes may impact absorption”; and that “[b]ased on the severity of the indication and the availability of approved safe and effective products, we need to have confidence that efficacy and safety of epinephrine administered by this novel route of administration have been established; residual uncertainties should be minimized.”
On this news, ARS’s 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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CONTACT:
Robert S. Willoughby
Pomerantz LLP
888-476-6529 ext. 7980