Daiichi Sankyo Company ((DSKYF)) announced an update on their ongoing clinical study.
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Study Overview: Daiichi Sankyo Company is conducting a long-term study titled A Long-term Study to Further Evaluate the Risk of Hepatotoxicity Associated With TURALIO™ (Pexidartinib) Treatment. The study aims to assess the long-term risk of liver damage in patients treated with TURALIO™ for Tenosynovial Giant Cell Tumor (TGCT), focusing on understanding the mechanism of liver injury through optional liver biopsies.
Intervention/Treatment: The study is observational and focuses on the drug TURALIO™ (pexidartinib). It is designed to evaluate the risk of hepatic failure in patients experiencing hepatotoxicity due to the drug, without providing any study medication to participants.
Study Design: This is a prospective, observational cohort study. It does not involve any allocation or masking, as it is non-interventional. The primary purpose is to gather data on the long-term effects of TURALIO™ on liver health.
Study Timeline: The study began on October 29, 2020, and is currently recruiting participants. The latest update was submitted on September 30, 2025. These dates are crucial as they indicate the study’s progress and ongoing nature.
Market Implications: This study could impact Daiichi Sankyo’s stock performance and investor sentiment, especially if significant risks are identified. The findings may influence the competitive landscape for treatments targeting TGCT, as safety profiles are critical in drug adoption and market share.
The study is ongoing, with further details available on the ClinicalTrials portal.