Biogen Inc. ((BIIB)), Biogen ((CC:HTER)) announced an update on their ongoing clinical study.
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Biogen Inc. (BIIB), in collaboration with Alcyone Therapeutics, is conducting a pivotal clinical study titled ‘Safety and Performance of the ThecaFlex DRx™ System Port and Catheter for Chronic Intrathecal Access, Cerebrospinal Fluid (CSF) Aspiration, and Delivery of Nusinersen in Spinal Muscular Atrophy (SMA) Patients Resistant to Lumbar Puncture Trial (PIERRE)’. The study aims to demonstrate the successful clinical use of the ThecaFlex DRx™ System in delivering nusinersen to patients with Spinal Muscular Atrophy (SMA), a significant step towards obtaining Pre-Market Approval (PMA).
The intervention being tested is the ThecaFlex DRx™ System, an implantable device designed for intrathecal delivery of nusinersen, specifically for patients who are unable to undergo lumbar puncture due to complex spine conditions. This system is intended to facilitate safe and effective delivery of necessary treatments for SMA patients.
The study is designed as a multicenter, multinational, prospective, non-randomized, single-arm trial. It follows a group sequential design to assess the safety and performance of the ThecaFlex DRx™ System, with no masking involved. The primary purpose of the study is treatment-focused, aiming to improve therapeutic delivery in SMA patients.
The study commenced on November 27, 2023, with an estimated completion date set for June 30, 2025. These dates are crucial as they mark the timeline for data collection and analysis, which will support the PMA application. The last update was submitted on June 30, 2025, indicating ongoing progress in the study.
This clinical study update could potentially impact Biogen’s stock performance positively, as successful results may enhance investor confidence and market position in the SMA treatment landscape. The study’s progress is particularly relevant in the context of competitive advancements in SMA therapies.
The study is currently recruiting, and further details are available on the ClinicalTrials portal.