Catalyst Event
Biogen Inc (BIIB) · Other
From Akros U.S. Large Cap 500 Protective Allocation Monthly Index (A500PAM)
5/8/2026, 12:00:00 AM
On May 8, 2026, the U.S. FDA extended the review period for the supplemental Biologics License Application (sBLA) for a subcutaneous version of LEQEMBI. A low price impact (≥1%) is estimated due to the regulatory delay.
Korean Translation
2026년 5월 8일, 미국 FDA가 레켐비(LEQEMBI) 피하주사 제형의 추가 생물학적 제제 허가 신청(sBLA) 검토 기간을 연장함. 일정 지연에 따른 1% 이상의 주가 영향이 예상됨.
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