FDA approves ARS Pharma's neffy epinephrine nasal spray for allergic reactions

ARS Pharmaceuticals, Inc.

FDA approved neffy on Aug 9, 2024 for emergency treatment of anaphylaxis in adults and children ≥30 kg.
Approval based on five registration studies showing pharmacokinetic/pharmacodynamic data within range of approved injectable epinephrine.
neffy expected to be available in US within 8 weeks; plan to file sNDA for children 15-<30 kg by end of Q3 2024.
CHMP positive opinion in EU on June 27; EMA decision expected Q3 2024; European commercial launch expected Q4 2024 via partner.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.