Femasys Inc FEMY
Femasys Inc (Nasdaq: FEMY) is an endocrine/women's health medical device company.
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| FemBloc (US PMA pivotal IDE trial, NCT05977751) | permanent birth control | device-combination | NA_NON_THERAPEUTIC |
| FemaSeed intratubal insemination | infertility | device-combination | NA_NON_THERAPEUTIC |
| FemVue / FemChec / FemCerv / FemVue Controlled | diagnostic devices | — | NA_NON_THERAPEUTIC |
Recent results and decisions
- Mar 31, 2026started Patient enrollment initiated in the FINALE pivotal trial of FemBloc.
Initiated patient enrollment in the FINALE pivotal clinical trial evaluating FemBloc, advancing toward U.S. approval.
Filing - Mar 31, 2026approval FDA 510(k) clearance for the FemVue Controlled device.
Secured FDA 510(k) clearance for the FemVue® Controlled device
Filing - Nov 3, 2025approval FDA IDE approval to continue enrollment in Part B (final phase) of the FINALE pivotal trial after completion of Part A.
announced today U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval to continue enrollment in the final phase (Part B) of the FINALE pivotal trial for FemBloc
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other endocrine/women's health companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.