secwatch.observer — SEC 8-K summary
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Issuer:     ARS Pharmaceuticals, Inc. (SPRY)
CIK:        0001671858
Form:       8-K
Filed at:   2024-08-12T23:59:59+00:00
Accession:  0001193125-24-198384
Event type: regulatory
Sentiment:  positive
Materiality: 0.90
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1671858/000119312524198384/0001193125-24-198384-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1671858/000119312524198384/d844683d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-24-198384

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