secwatch.observer — SEC 8-K summary
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Issuer:     SOLENO THERAPEUTICS INC (SLNO)
CIK:        0001484565
Form:       8-K
Filed at:   2024-04-29T23:59:59+00:00
Accession:  0001193125-24-122237
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Soleno gets FDA Breakthrough Therapy Designation for DCCR in Prader-Willi Syndrome
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- FDA grants Breakthrough Therapy Designation for DCCR (diazoxide choline) in adults/children ≥4 yrs with PWS and hyperphagia.
- First ever Breakthrough Therapy Designation for a drug developed for PWS; based on Phase 3 program data.
- NDA submission for DCCR in PWS remains on track for mid-2024.
- DCCR also has Orphan Drug Designation in US and EU and Fast Track Designation in US.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1484565/000119312524122237/0001193125-24-122237-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1484565/000119312524122237/d827294d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-24-122237

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