secwatch.observer — SEC 8-K summary
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Issuer:     Dare Bioscience, Inc. (DARE)
CIK:        0001401914
Form:       8-K
Filed at:   2023-07-05T23:59:59+00:00
Accession:  0001493152-23-023364
Event type: other_material
Sentiment:  positive
Materiality: 0.65
Item codes: 1.01, 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Daré receives $1M from Organon, revises milestone payments for XACIATO; targeting 2023 US launch
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- Organon pays Daré $1.0M in July 2023 to reimburse PDUFA fees and manufacturing costs under amended license.
- Upon first US commercial sale of XACIATO, Organon to pay Daré $1.8M (revised from prior amount).
- Daré eligible for up to $180M in future milestones and tiered double-digit royalties on net sales.
- Manufacturing validation completed; additional activities ongoing for continuity of supply for 2023 US launch.
- XACIATO is FDA-approved for bacterial vaginosis in females 12+; Organon is commercial partner.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1401914/000149315223023364/0001493152-23-023364-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1401914/000149315223023364/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-23-023364

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