Polaris Pharmaceuticals-KY (北極星藥業-KY; 6550 TT) convened a Board of Directors meeting on May 25, 2026, passing three major corporate restructurings: the temporary suspension of its clinical trial for Leiomyosarcoma (LMS); the voluntary withdrawal of its Biologics License Application (BLA) for Malignant Pleural Mesothelioma (MPM) with the US FDA; and a structural reorganization and headcount adjustment across its wholly owned US subsidiaries.

• LMS Clinical Suspension: Acting upon an interim data analysis mechanism embedded within the original clinical trial design, and incorporating the formal recommendation of the Independent Data Monitoring Committee (IDMC), Polaris evaluated its LMS clinical advancement, ongoing regulatory alignment, and macro capital allocation. The board decided to suspend new patient enrollment and subsequent clinical site openings to optimize target patient cohorts and refine future trial design.
• Voluntary BLA Withdrawal for MPM: Polaris had been actively submitting supplemental datasets requested by federal reviewers during the ongoing evaluation of its MPM BLA. However, citing long-term commercialization logistics and a realigned corporate asset management strategy, the board opted to voluntarily withdraw the current BLA submission. The company will conduct deep-dive exploratory data analyses on its existing clinical readouts to reassess patient stratification, likelihood of clinical benefit, and overall development feasibility before charting future regulatory tracks.

Resource:北極星暫緩新藥臨床試驗