Amneal Pharma ((AMRX)), Sandoz Group Ltd ((SDZXF)), Alkem Laboratories Ltd. ((IN:ALKEM)), Concord Biotech Ltd. ((IN:CONCORDBIO)) announced an update on their ongoing clinical study.
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The Mycophenolate Pregnancy Registry, officially titled the same, is a prospective, observational study aimed at gathering data on mycophenolate exposure during pregnancy and its outcomes. This study, sponsored by Genentech, Inc., with collaborators including Amneal Pharmaceuticals, Alkem Laboratories, Concord Biotech, and Sandoz, seeks to understand the impact of mycophenolate on pregnancy, fetal, and infant outcomes, which is crucial for evaluating the safety of mycophenolate formulations like CellCept and Myfortic.
The study focuses on mycophenolate, a medication used primarily in organ transplantation and autoimmune diseases, to monitor pregnancy outcomes and potential birth defects. This is part of a Risk Evaluation and Mitigation Strategy (REMS) mandated by the FDA.
This observational study follows a cohort model with a prospective time perspective. It does not involve random allocation or masking, as it is designed to observe natural outcomes rather than test interventions.
The study began on November 20, 2012, with the latest update submitted on October 9, 2025. These dates are significant as they reflect the ongoing nature of the study and its long-term commitment to collecting comprehensive data.
For investors, this study update could influence stock performance and investor sentiment for companies like Amneal, Alkem, Concord Biotech, and Sandoz. The study’s findings may impact the market for mycophenolate formulations, potentially affecting these companies’ market positions and competitive dynamics within the pharmaceutical industry.
The Mycophenolate Pregnancy Registry is ongoing, with further details available on the ClinicalTrials portal.