---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-24-172238"
form_type: "8-K"
ticker: "SLNO"
cik: "0001484565"
company_name: "SOLENO THERAPEUTICS INC"
filed_at: "2024-06-28T23:59:59+00:00"
generated_at: "2026-06-01T00:32:28.390507+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Soleno submits NDA to FDA for DCCR to treat Prader-Willi Syndrome

## Summary
- NDA submitted for DCCR (diazoxide choline) extended-release tablets for PWS in patients aged 4+ with hyperphagia.
- DCCR holds Breakthrough Therapy and Fast Track designations in the U.S.; Orphan Drug designation in U.S. and EU.
- FDA has 60 days to determine if NDA will be accepted; Soleno requested Priority Review (6-month target review).
- CEO Anish Bhatnagar called the submission a significant milestone for Soleno and the PWS community.

## SEC filing metadata
- accession: 0001193125-24-172238
- form_type: 8-K
- ticker: SLNO
- cik: 0001484565
- company_name: SOLENO THERAPEUTICS INC
- filed_at: 2024-06-28T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1484565/000119312524172238/0001193125-24-172238-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1484565/000119312524172238/d832323d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-24-172238
- JSON: https://secwatch.observer/filing/0001193125-24-172238.json
- Plain text: https://secwatch.observer/filing/0001193125-24-172238.txt

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