secwatch.observer — SEC 8-K summary
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Issuer:     SOLENO THERAPEUTICS INC (SLNO)
CIK:        0001484565
Form:       8-K
Filed at:   2024-11-26T23:59:59+00:00
Accession:  0001193125-24-265687
Event type: regulatory
Sentiment:  neutral
Materiality: 0.70
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA extends PDUFA date for Soleno's DCCR NDA to March 27, 2025
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- FDA extended review period by three months from Dec 27, 2024, to March 27, 2025.
- Extension due to FDA deeming responses to recent info requests a major amendment.
- FDA did not cite any safety, efficacy, or manufacturing concerns in correspondence.
- NDA for DCCR to treat hyperphagia in Prader-Willi syndrome patients aged 4+.
- DCCR has Breakthrough, Fast Track, and Orphan Drug designations in US and EU.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1484565/000119312524265687/0001193125-24-265687-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1484565/000119312524265687/d802129d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-24-265687

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