Organon Secures Exclusive Rights to MIUDELLA, First New Hormone-Free Copper IUD in Over 40 Years

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Summary · why it matters

Organon has completed a global licensing agreement with Sebela Pharmaceuticals for exclusive rights to MIUDELLA, a hormone-free copper intrauterine device approved by the U.S. FDA in February 2025. MIUDELLA is the first hormone-free copper IUD launched in the U.S. in more than four decades, designed to prevent pregnancy for up to three years with 99% effectiveness. The device features SLIMSERT technology with a flexible frame and a preloaded insertion system using a 3.7mm tapered tube, and is expected to become commercially available in late 2026. Separately, Organon expanded its partnership with Samsung Bioepis, gaining exclusive commercialization rights in Canada for Pyzchiva, a biosimilar referencing Stelara, intended for multiple inflammatory conditions and expected to launch in 2026.

Impact on stocks 1

Health Care▲ · 1 stocks
Organon & Co
OGN
▲ PositiveTechnologyDemandrelevance

Organon secures exclusive global rights to MIUDELLA, a novel hormone-free copper IUD approved by FDA, expanding its product portfolio.

Off-coverage companies 2

Sebela Pharmaceuticals Inc.Private▲ Positive
Capitalrelevance

Sebela Pharmaceuticals licenses MIUDELLA to Organon, generating upfront and milestone payments.

Samsung BioepisPrivate▲ Positive
Demandrelevance

Samsung Bioepis expands partnership with Organon for Pyzchiva commercialization in Canada, potentially increasing biosimilar sales.

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