---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-064140"
form_type: "8-K"
ticker: "SLNO"
cik: "0001484565"
company_name: "SOLENO THERAPEUTICS INC"
filed_at: "2025-03-26T23:59:59+00:00"
generated_at: "2026-05-24T04:53:58.602355+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# FDA approves Soleno's VYKAT XR for hyperphagia in Prader-Willi syndrome

## Summary
- VYKAT XR (diazoxide choline) is first approved therapy for hyperphagia in PWS; for ages 4+.
- Approval based on Phase 3 randomized withdrawal study with mean of 3.3 years prior treatment.
- Most common adverse reactions (≥10% and ≥2% over placebo): hypertrichosis, edema, hyperglycemia, rash.
- Soleno expects VYKAT XR to be available in the U.S. starting April 2025.
- Company launched Soleno One patient support program; conference call/webcast at 5:30 p.m. ET today.

## SEC filing metadata
- accession: 0001193125-25-064140
- form_type: 8-K
- ticker: SLNO
- cik: 0001484565
- company_name: SOLENO THERAPEUTICS INC
- filed_at: 2025-03-26T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1484565/000119312525064140/0001193125-25-064140-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1484565/000119312525064140/d833373d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-064140
- JSON: https://secwatch.observer/filing/0001193125-25-064140.json
- Plain text: https://secwatch.observer/filing/0001193125-25-064140.txt

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