Organon stock: Organon presents six-year MIUDELLA data. What it means for Organon stock

Published on 10/23/2026 at 05:03 | Editorial responsibility: Rafael Müller, Editor-in-Chief AD HOC NEWS

Organon reported a 0.93 Pearl Index through six years on October 16, 2026. For Organon stock, FDA review targets use up to 6 years.

Clinical evidence and market context

Organon reported a 0.93 six-year Pearl Index for MIUDELLA on October 16, 2026.
The Phase 3 study spans 42 United States sites and evaluates use through six years.
Organon's market capitalization was USD 3.6 billion on October 22, 2026.

OGN, US68622V1061, Illustration mit AI erstellt.

Organon (ISIN US68622V1061) reported a cumulative 0.93 Pearl Index for its MIUDELLA contraceptive device through six years of use on October 16, 2026. According to Organon, the data support a regulatory review of longer use for MIUDELLA.

Clinical results support longer use

The prospective Phase 3 study covers 42 United States sites and assessed six-year outcomes in 465 of 1,397 participants in the pregnancy-evaluable group and 592 of 1,601 participants in the safety group. The cumulative Kaplan-Meier pregnancy rate was 3.9 percent at six years, giving investors a second measure of the device's performance.

The study also provides a useful comparison over time. Bleeding- and pain-related discontinuations affected 8.7 percent of participants in year one, compared with 1.9 percent in year six. The release said follow-up continues, while the current MIUDELLA indication covers use for up to three years.

Three milestones carry figures

On October 1, 2026, Organon listed a planned real-world analysis of VTAMA 1 percent cream at a clinical dermatology conference. On October 16, 2026, the company reported the MIUDELLA results, including the 0.93 Pearl Index. On October 19, 2026, Yahoo Finance carried Organon's announcement that it plans to file its third-quarter 2026 Form 10-Q and related Form 8-K.

What dates matter for MIUDELLA?

The study presentation was scheduled for October 17, 2026, at the Society of Family Planning Annual Meeting. The FDA's PDUFA decision on the application to extend MIUDELLA use to six years is expected in the second quarter of 2027, according to Organon. The key uncertainty is commercial execution, because the device remains subject to a restricted training and enrollment program.

Market context for investors

Organon had a market capitalization of USD 3.6 billion on October 22, 2026. Its 52-week range was USD 5.69 to USD 13.83 on the same date, placing the company near the upper end of its annual trading band. The valuation context gives the clinical update greater importance, but the study results do not establish future revenue or regulatory approval.

The further course of trading is shown by the continuously updated real-time quote of Organon stock.