secwatch.observer — SEC 8-K summary
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Issuer:     SOLENO THERAPEUTICS INC (SLNO)
CIK:        0001484565
Form:       8-K
Filed at:   2023-09-26T23:59:59+00:00
Accession:  0001193125-23-241845
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Soleno reports positive Phase 3 results for DCCR in Prader-Willi; primary endpoint met (p=0.0022)
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- Primary endpoint: HQ-CT total score difference of 5.0 at week 16 (p=0.0022) favoring DCCR over placebo.
- Secondary endpoints (CGI-S, CGI-I) showed trends toward worsening in placebo group (p=0.08 and 0.09).
- DCCR well-tolerated; no serious adverse events or discontinuations in DCCR group.
- Positive data triggers $15M warrant exercise (8.6M shares at $1.75) within 30 days by Nantahala, Abingworth, Vivo.
- Company targets NDA submission for DCCR in PWS mid-2024; FDA previously acknowledged potential for NDA support.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1484565/000119312523241845/0001193125-23-241845-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1484565/000119312523241845/d486361d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-23-241845

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