Amgen’s UPLIZNA Pregnancy Safety Study: Key Insights for Investors

Amgen Inc ((AMGN)) announced an update on their ongoing clinical study.

Amgen Inc. is conducting an observational study titled An Observational Pregnancy Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® (Inebilizumab-cdon) During Pregnancy. The study aims to monitor the safety of UPLIZNA exposure during pregnancy in women with NMOSD, collecting data on pregnancy outcomes and related factors. This research is significant as it addresses the safety concerns of using UPLIZNA during pregnancy, potentially influencing treatment protocols for pregnant women with NMOSD.

The intervention being tested is UPLIZNA, a drug used to treat NMOSD. The study focuses on women who have been exposed to this drug during pregnancy, assessing its safety and effects on pregnancy outcomes.

The study is observational in design, meaning it does not involve administering the drug as part of the study. Instead, it collects data from women already exposed to UPLIZNA. The primary purpose is to gather safety data, with no specific allocation or intervention model applied.

The study began on June 9, 2023, and is currently recruiting participants. The primary completion and estimated overall completion dates are not specified, but the study’s last update was submitted on June 16, 2025. These dates are crucial for tracking the study’s progress and ensuring timely updates on its findings.

The market implications of this study are significant for Amgen’s stock performance and investor sentiment. Positive safety data could enhance UPLIZNA’s market position, especially in the NMOSD treatment landscape. Investors should monitor this study as its outcomes may influence Amgen’s competitive edge in the pharmaceutical industry.

The study is ongoing, with further details available on the ClinicalTrials portal.