secwatch.observer — SEC 8-K summary
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Issuer:     SOLENO THERAPEUTICS INC (SLNO)
CIK:        0001484565
Form:       8-K
Filed at:   2024-06-28T23:59:59+00:00
Accession:  0001193125-24-172238
Event type: regulatory
Sentiment:  neutral
Materiality: 0.80
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Soleno submits NDA to FDA for DCCR to treat Prader-Willi Syndrome
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- NDA submitted for DCCR (diazoxide choline) extended-release tablets for PWS in patients aged 4+ with hyperphagia.
- DCCR holds Breakthrough Therapy and Fast Track designations in the U.S.; Orphan Drug designation in U.S. and EU.
- FDA has 60 days to determine if NDA will be accepted; Soleno requested Priority Review (6-month target review).
- CEO Anish Bhatnagar called the submission a significant milestone for Soleno and the PWS community.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1484565/000119312524172238/0001193125-24-172238-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1484565/000119312524172238/d832323d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-24-172238

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