---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-24-122237"
form_type: "8-K"
ticker: "SLNO"
cik: "0001484565"
company_name: "SOLENO THERAPEUTICS INC"
filed_at: "2024-04-29T23:59:59+00:00"
generated_at: "2026-06-03T05:30:04.420307+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Soleno gets FDA Breakthrough Therapy Designation for DCCR in Prader-Willi Syndrome

## Summary
- FDA grants Breakthrough Therapy Designation for DCCR (diazoxide choline) in adults/children ≥4 yrs with PWS and hyperphagia.
- First ever Breakthrough Therapy Designation for a drug developed for PWS; based on Phase 3 program data.
- NDA submission for DCCR in PWS remains on track for mid-2024.
- DCCR also has Orphan Drug Designation in US and EU and Fast Track Designation in US.

## SEC filing metadata
- accession: 0001193125-24-122237
- form_type: 8-K
- ticker: SLNO
- cik: 0001484565
- company_name: SOLENO THERAPEUTICS INC
- filed_at: 2024-04-29T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1484565/000119312524122237/0001193125-24-122237-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1484565/000119312524122237/d827294d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-24-122237
- JSON: https://secwatch.observer/filing/0001193125-24-122237.json
- Plain text: https://secwatch.observer/filing/0001193125-24-122237.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.