Pre-market Shock: ARS Pharmaceuticals Faces Setback
- September 20th, 2023
- 539 views
Shares of ARS Pharmaceuticals, Inc. (Nasdaq: SPRY) plunged over 40% following the announcement that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding its New Drug Application (NDA) for neffy (epinephrine nasal spray) in the treatment of Allergic Reactions (Type I), including anaphylaxis for adults and children weighing 30 kg or more. The company plans to submit a Formal Dispute Resolution Request (FDRR) to appeal the FDA's decision.
The FDA's request for a pharmacokinetic/pharmacodynamic study assessing repeat doses of neffy aims to support approval, despite the prior recommendation of the FDA Advisory Committee (PADAC) in May 2023 to approve neffy without the need for additional studies to demonstrate its efficacy or safety, also indicating a favorable benefit-risk profile for ARS Pharmaceuticals' intranasal epinephrine product.
$SPRY was trading at $3.51 in pre-market, reflecting a substantial decline of $3.09 (-46.85%)
THIS IS NOT A RECOMMENDATION TO BUY OR SELL ANY SECURITY OR DIGITAL ASSET. Please consult with a professional investment advisor before purchasing or selling any securities viewed on or mentioned herein. (Read Full Disclaimer)
Post Your Comments
Want To Find Some News?
Recent Posts
-
Key Earnings Ahead for Netflix, Fastenal, and U.S. Bancorp
January 18th, 2026Louisville Thunder Appoints Veteran Coach Mike Reed to Lead Program
January 15th, 2026FDA Approves First Treatment for Children With Menkes Disease
January 13th, 2026January 13th, 2026Wall Street Eyes Bank of America, Wells Fargo, Citi Ahead of Earnings
January 11th, 2026
Member Login