The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of ARS Pharmaceuticals, Inc. (“ARS” or “the Company”) (NASDAQ: SPRY) for violations of the securities laws.
The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors. ARS announced in a May 9, 2023, press release that the FDA posted briefing documents for an upcoming review of the Company’s NDA for neffy® (ARS-1). The FDA noted that “establishing 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." The agency added, “based 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." Based on this news, shares of ARS fell by 14% in intraday trading on the same day.
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