---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-199882"
form_type: "8-K"
ticker: "SLNO"
cik: "0001484565"
company_name: "SOLENO THERAPEUTICS INC"
filed_at: "2025-09-10T23:59:59+00:00"
generated_at: "2026-05-17T06:58:58.579194+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Soleno reports death of VYKAT XR patient; company says not drug-related

## Summary
- A 17-year-old male with lymphedema, thrombophlebitis, and obesity died from pulmonary embolus; FAERS report filed.
- Treating physician and Soleno assessed the death as not related to VYKAT XR treatment.
- Soleno reaffirms VYKAT XR safety profile and urges use per FDA-approved label.
- Company will not comment on future adverse events unless directly linked to VYKAT XR and unexpected per label.
- Prader Willi Syndrome patients have reduced life expectancy; mean age of death is 29.5 years per 40-year study.

## SEC filing metadata
- accession: 0001193125-25-199882
- form_type: 8-K
- ticker: SLNO
- cik: 0001484565
- company_name: SOLENO THERAPEUTICS INC
- filed_at: 2025-09-10T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 7.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1484565/000119312525199882/0001193125-25-199882-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1484565/000119312525199882/d88981d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-199882
- JSON: https://secwatch.observer/filing/0001193125-25-199882.json
- Plain text: https://secwatch.observer/filing/0001193125-25-199882.txt

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