Swedish Orphan Biovitrum Ab ((GB:0MTD)) announced an update on their ongoing clinical study.
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Swedish Orphan Biovitrum AB is conducting a Phase 4 clinical study titled ‘A 12-month, Interventional, Open-label, Phase 4 Study in Europe (SHINE) to Investigate the Course of Synovial Hypertrophy as Detected by Joint Ultrasound and MRI in Patients With Haemophilia A on Efanesoctocog Alfa Prophylaxis.’ The study aims to evaluate the effectiveness of efanesoctocog alfa in improving synovial hypertrophy and preventing joint bleeds in patients with moderate or severe haemophilia A.
The intervention being tested is a drug called efanesoctocog alfa, administered as a 50 IU/kg intravenous injection once weekly. Its purpose is to enhance joint health by reducing synovial hypertrophy and minimizing the risk of joint bleeds.
This interventional study follows a single-group model without masking, primarily focusing on treatment. The study is open-label, meaning both researchers and participants know the treatment being administered.
The study began on December 18, 2024, with the primary completion date yet to be announced. The latest update was submitted on September 15, 2025. These dates are crucial as they mark the study’s progress and timeline for potential results.
The update on this study could positively influence Swedish Orphan Biovitrum’s stock performance by demonstrating progress in their clinical pipeline, potentially enhancing investor confidence. Competitors in the haemophilia treatment market may also be closely monitoring these developments.
The study is currently recruiting, and further details are available on the ClinicalTrials portal.