Femasys doubles enrollment sites for FemBloc pivotal trial to 12 U.S. locations
Femasys Inc. announced that the number of actively enrolling sites in its FemBloc FINALE pivotal trial has been increased from six to twelve across the United States. The added locations are Baylor Research Institute and Columbia University Medical Center, joining four existing academic sites. An initial safety cohort of 50 women has completed enrollment, allowing the FDA to authorize full enrollment. The trial will enroll 401 women, with an interim analysis after 300 participants reach one year.
Why it matters
The expansion signals progress toward FDA approval and may affect investor sentiment; the company's stock fell 7.95% to $1.62 following the announcement (rttnews).
Key facts
- 1The number of actively enrolling sites in the FemBloc FINALE pivotal trial was increased to twelve across the United States. rttnews.com
- 2The new sites are Baylor Research Institute and Columbia University Medical Center. rttnews.com
- 3An initial safety cohort of 50 women has completed enrollment, enabling FDA authorization for full enrollment. rttnews.com
- 4The trial plans to enroll 401 women, with an interim analysis after 300 participants reach the one‑year mark. rttnews.com
- 5Femasys stock is trading at $1.62, down 7.95% after the announcement. rttnews.com
- 6CEO Kathy Lee‑Sepsick said the August 2026 financing enabled the site expansion and progress on the U.S. regulatory strategy. rttnews.com
Summary written by AlphAI AI Desk from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.