Biogen Inc. ((BIIB)), Biogen ((CC:HTER)) announced an update on their ongoing clinical study.
Confident Investing Starts Here:
- Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions
- Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter
Biogen Inc. (BIIB) has launched a post-marketing observational study titled A Post-marketing, Observational, Descriptive Study to Assess the Risk Associated With Pregnancy, the Maternal Complications, and Adverse Effects on the Developing Fetus, Neonate, and Infant Among Individuals Exposed to Omaveloxolone During Pregnancy and/or Lactation. The study aims to evaluate the safety of BIIB141, also known as omaveloxolone or SKYCLARYS, in individuals with Friedrich’s Ataxia (FA) who have taken the drug during pregnancy or breastfeeding. The primary objective is to assess the risk of major and minor birth defects, maternal complications, and developmental issues in infants.
The intervention being tested is the drug Omaveloxolone, which is already available for prescription to individuals with FA. The study will observe participants who have been exposed to the drug during pregnancy and/or lactation to gather data on its safety profile.
This observational study follows a cohort model with a prospective time perspective. Participants will be monitored for up to one year after childbirth, with health data collected from regular doctor visits. The study does not involve any changes to participants’ medical care.
The study is currently recruiting, with an estimated start date of October 26, 2026. The study was first submitted on September 30, 2024, and the last update was submitted on June 23, 2025. These dates are crucial as they mark the progression and timeline of the study, which is expected to last at least 10 years.
This update could influence Biogen’s stock performance and investor sentiment, as the study’s findings may impact the market perception of omaveloxolone’s safety and efficacy. Competitors in the FA treatment space will also be closely monitoring the study’s outcomes.
The study is ongoing, and further details can be accessed on the ClinicalTrials portal.