secwatch.observer — SEC 8-K summary
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Issuer:     SOLENO THERAPEUTICS INC (SLNO)
CIK:        0001484565
Form:       8-K
Filed at:   2026-04-07T23:59:59+00:00
Accession:  0001193125-26-144511
Event type: regulatory
Sentiment:  negative
Materiality: 0.75
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

Soleno withdraws EU marketing application for VIOKAT (PWS hyperphagia)
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- Voluntarily withdrew MAA for VIOKAT (diazoxide choline) from EMA for Prader-Willi syndrome hyperphagia.
- Decision based on business and strategic considerations; company may re-engage with regulators later.
- VIOKAT is marketed in the US as VYKAT XR for adults and children aged 4+ with PWS.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1484565/000119312526144511/0001193125-26-144511-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1484565/000119312526144511/d141594d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-144511

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