secwatch.observer — SEC 8-K summary
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Issuer:     Dare Bioscience, Inc. (DARE)
CIK:        0001401914
Form:       8-K
Filed at:   2023-12-20T23:59:59+00:00
Accession:  0001493152-23-045515
Event type: other_material
Sentiment:  positive
Materiality: 0.65
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Dare Bioscience reports positive Phase 1 topline results for DARE-PDM1 in primary dysmenorrhea
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- DARE-PDM1 (vaginal diclofenac hydrogel) was well-tolerated; no serious AEs; 85% of AEs mild.
- Vaginal fluid PK showed dose proportionality and retention in vaginal canal for 24 hours.
- Exploratory efficacy: statistically significant reduction in pelvic/vaginal and lower back pain for 1% DARE-PDM1 vs placebo.
- Plasma PK data pending; company plans continued development and 505(b)(2) regulatory pathway.
- DARE-PDM1 has potential as first-in-category vaginal treatment for primary dysmenorrhea; market estimated $13B in 2022.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1401914/000149315223045515/0001493152-23-045515-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1401914/000149315223045515/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-23-045515

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