TOKYO, Jun 18 (Pulse News Wire) – Shionogi & CO.,LTD. (4507.T) reported positive results from its global Phase 3 clinical trial (OASIS study) for the new antifungal drug orofim.
The trial demonstrated non-inferiority to the comparator group in the primary endpoint of overall mortality rate 42 days post-treatment. Additionally, orofim showed no new safety concerns, with adverse events related to the drug occurring at rates of 35.8% for the orofim group compared to 63.9% for the AmBisome® group. Shionogi's Chief Executive Officer Motohiro Tabayashi stated, “This result supports the therapeutic utility of orofim among patients with limited treatment options.” Based on these findings, Shionogi plans to file for approval in Europe and Asia, while F2G Ltd.
Intends to apply for FDA approval in the United States. Further details of the trial will be presented at international conferences in the future. The impact on Shionogi’s fiscal year 2027 linked performance is expected to be minor.
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