BOSTON, May 10, 2023 (GLOBE NEWSWIRE) -- Block & Leviton is investigating ARS Pharmaceuticals, Inc. (NASDAQ: SPRY) for potential securities law violations. Investors who have lost money in their ARS Pharmaceuticals investment should contact the firm to learn more about how they might recover those losses. For more details, visit https://www.blockleviton.com/cases/spry.
What is this all about?
On May 9, 2023, ARS Pharmaceuticals, Inc. issued a press release announcing that the U.S. Food and Drug Administration (FDA) posted briefing documents for the upcoming Pulmonology, Allergy-Drugs Advisory Committee (PADAC) meeting to review the Company’s new drug application (NDA) for neffy® (ARS-1) for the treatment of Type 1 allergic reactions including anaphylaxis on May 11, 2023.
FDA scientists expressed some concern in the briefing documents noting 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 FDA 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.”
ARS Pharmaceuticals did not conduct any clinical trials to demonstrate efficacy and is instead relying on pharmacokinetic (“PK”)/pharmacodynamic (“PD”) data comparing ARS-1 to approved epinephrine injections.
Shares of ARS Pharmaceuticals stock dropped more than 14% in intraday trading on May 9, 2023.
Who is eligible?
Anyone who purchased ARS Pharmaceuticals, Inc. stock and has lost money may be eligible, whether or not they have sold their investment. Investors should contact Block & Leviton to learn more.
What is Block & Leviton doing?
Block & Leviton is investigating whether the Company committed securities law violations and may file an action to attempt to recover losses on behalf of investors who have lost money.
What should you do next?
If you’ve lost money on your investment, you should contact Block & Leviton to learn more via our case website, by email at cases@blockleviton.com, or by phone at (617) 398-5600.
Why should you contact Block & Leviton?
Many law firms have issued releases about this matter; most of those firms do not actually litigate securities class actions. Block & Leviton is a law firm that actually litigates cases. We are dedicated to obtaining significant recoveries on behalf of defrauded investors through active litigation in the federal courts across the country. Many of the nation’s top institutional investors hire us to represent their interests. You can learn more about us at our website, www.blockleviton.com, or call (617) 398-5600 or email cases@blockleviton.com with any questions.
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CONTACT:
BLOCK & LEVITON LLP
260 Franklin St., Suite 1860
Boston, MA 02110
Phone: (617) 398-5600
Email: cases@blockleviton.com
SOURCE: Block & Leviton LLP
www.blockleviton.com
