Bayer AG ((BAYRY)), Bayer Ag (UK) ((GB:0P6S)) announced an update on their ongoing clinical study.
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Bayer AG, in collaboration with Biogen, Novartis, and Merck, is conducting an observational study titled ‘INFORM – Interferon-Beta Exposure in the 2nd and 3rd Trimester of Pregnancy.’ The study aims to assess the safety of interferon-beta (IFNB) exposure during late pregnancy in Finland and Sweden, following a label change by the European Medicines Agency in 2019. This research is significant as it seeks to determine if the number of pregnancies exposed to IFNB is sufficient to conduct a cohort study on adverse pregnancy outcomes.
The study investigates the use of IFNB drugs such as Avonex, Rebif, Extavia, Betaseron, and Plegridy, which are used to treat multiple sclerosis. These drugs are being evaluated for their safety during the second and third trimesters of pregnancy.
This observational study uses a cohort model to gather data retrospectively. It focuses on pregnancies exposed to IFNB, with or without other multiple sclerosis disease-modifying drugs, compared to those unexposed. The primary purpose is to gather drug utilization data to inform future cohort studies.
The study began on March 20, 2024, with an estimated completion date yet to be determined. The last update was submitted on July 25, 2025. These dates are crucial as they mark the progress and timeline of data collection and analysis.
For investors, this study could impact Bayer’s stock performance by providing insights into the safety profile of IFNB during pregnancy, potentially influencing market confidence and regulatory decisions. As competitors like Biogen and Novartis are also involved, the study’s outcomes could affect the broader industry landscape.
The INFORM study is ongoing, with further details available on the ClinicalTrials portal.