Nexplanon — Regulatory decision
in 2027
The EU application is currently under review, with potential approval in 2027, subject to health authority review and approval.Source filing
OGN biotech catalysts & pipeline
ORGANON & CO · Data as of 2026-10-25
Upcoming catalysts
MIUDELLA — PDUFA
Q2 2027
The U.S. Food and Drug Administration (FDA) accepted for review a supplemental New Drug Application (sNDA) for MIUDELLA for an extended duration of use for up to 6 years, with Prescription Drug User Fee Act (PDUFA) action expected in the second quarter of calendar year 2027.Source filing
MIUDELLA — Conference presentation
2026
Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, today announced that Sebela Women's Health will present interim results from an ongoing Phase 3 study evaluating MIUDELLA®, a hormone-free, copper intrauterine device (IUD), through 6 years of use at the 2026 Society of Family Planning (SFP) Annual Meeting, taking place October 17 to 19, 2026, in San Francisco, California.Source filing