Biogen Inc. ((BIIB)) announced an update on their ongoing clinical study.
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Biogen Inc. is currently conducting a study titled ‘Spinraza (Nusinersen) SMA Pregnancy Exposure Study Within Existing SMA Registries.’ The study aims to understand the effects of the drug nusinersen, known as Spinraza®, on pregnant participants with spinal muscular atrophy (SMA) and the health of their babies. This research is significant as it seeks to fill the knowledge gap regarding the impact of nusinersen on pregnancy outcomes and infant health in SMA patients.
The intervention being tested is nusinersen, a drug prescribed for SMA. The study is observational, meaning it collects health data without altering participants’ medical care. The primary goal is to gather birth and health information from pregnant participants who received nusinersen before or during pregnancy and compare it to those without SMA who have not taken the drug.
The study is designed as a cohort observational model with a prospective time perspective. Participants are followed throughout their pregnancy and up to 12 weeks postpartum, while their babies are monitored for up to two years after birth. The study will last at least 10 years from the first participant’s enrollment.
Key dates for the study include its start on March 16, 2023, with the latest update submitted on September 26, 2025. These dates are crucial for tracking the study’s progress and ensuring timely updates on its findings.
This study could have significant market implications for Biogen, potentially influencing its stock performance and investor sentiment. Positive results may strengthen Biogen’s position in the SMA treatment market, while also impacting competitors in the industry.
The study is ongoing, with further details available on the ClinicalTrials portal.