secwatch.observer — SEC 8-K summary
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Issuer:     SOLENO THERAPEUTICS INC (SLNO)
CIK:        0001484565
Form:       8-K
Filed at:   2025-03-26T23:59:59+00:00
Accession:  0001193125-25-064140
Event type: regulatory
Sentiment:  positive
Materiality: 0.90
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1484565/000119312525064140/0001193125-25-064140-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1484565/000119312525064140/d833373d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-064140

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer