Catalyst Event
Amgen Inc (AMGN) · Other
From KEDI Palantir Fixed Tech100 Index (KPLTT100)
5/21/2026, 12:00:00 AM
Japan's regulatory authority worked with Amgen's partner Kissei to update the Tavneos (avacopan) prescribing information to include a warning on serious liver injury, following reports of 20 patient deaths in Japan since 2022. This follows a temporary recommendation on May 15 to halt new patient prescriptions. High importance: significant regulatory risk and safety concerns; internal analysis estimates a >=10% price impact, estimated.
Korean Translation
일본 규제 당국이 2022년 이후 일본에서 발생한 20명의 환자 사망 보고에 따라, 암젠의 파트너사인 키세이 제약과 협력하여 타브네오스(아바코판) 처방 정보에 심각한 간 손상 경고 문구를 추가함. 이는 5월 15일 신규 환자 처방을 일시 중단하라는 권고에 이은 조치임. 높은 중요도: 심각한 규제 리스크 및 안전성 우려; 내부 분석 결과 10% 이상의 주가 영향이 예상됨.
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