---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-24-265687"
form_type: "8-K"
ticker: "SLNO"
cik: "0001484565"
company_name: "SOLENO THERAPEUTICS INC"
filed_at: "2024-11-26T23:59:59+00:00"
generated_at: "2026-05-29T17:47:09.303368+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# FDA extends PDUFA date for Soleno's DCCR NDA to March 27, 2025

## Summary
- FDA extended review period by three months from Dec 27, 2024, to March 27, 2025.
- Extension due to FDA deeming responses to recent info requests a major amendment.
- FDA did not cite any safety, efficacy, or manufacturing concerns in correspondence.
- NDA for DCCR to treat hyperphagia in Prader-Willi syndrome patients aged 4+.
- DCCR has Breakthrough, Fast Track, and Orphan Drug designations in US and EU.

## SEC filing metadata
- accession: 0001193125-24-265687
- form_type: 8-K
- ticker: SLNO
- cik: 0001484565
- company_name: SOLENO THERAPEUTICS INC
- filed_at: 2024-11-26T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1484565/000119312524265687/0001193125-24-265687-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1484565/000119312524265687/d802129d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-24-265687
- JSON: https://secwatch.observer/filing/0001193125-24-265687.json
- Plain text: https://secwatch.observer/filing/0001193125-24-265687.txt

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