secwatch.observer — SEC 8-K summary
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Issuer:     Dare Bioscience, Inc. (DARE)
CIK:        0001401914
Form:       8-K
Filed at:   2024-12-16T23:59:59+00:00
Accession:  0001493152-24-050117
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Daré announces Phase 3 plans for Sildenafil Cream for FSAD; protocol submission in Q1 2025
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- Will submit Phase 3 protocol and statistical plan to FDA in Q1 2025; target mid-2025 to start the study.
- A second confirmatory Phase 3 study will be required for NDA submission.
- Phase 3 co-primary endpoints are arousal sensations and associated distress, same as Phase 2b RESPOND study.
- Sildenafil Cream has potential to be first FDA-approved pharmacological treatment for FSAD (no current approved options).
- Market research estimates ~10M U.S. women distressed by FSAD symptoms actively seeking solutions.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1401914/000149315224050117/0001493152-24-050117-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1401914/000149315224050117/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-24-050117

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