Catalyst Event
Ionis Pharmaceuticals Inc (IONS) · Other
From KEDI Global Longevity Bio Index (KGLB)
3/23/2026, 12:00:00 AM
The U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for zilganersen for Alexander disease and granted it Priority Review, with a PDUFA target action date of September 22, 2026. A high price impact (>=10%) is estimated due to the significance of this regulatory milestone for a rare disease treatment.
Korean Translation
미국 식품의약국(FDA)이 알렉산더병 치료제 질가너센(zilganersen)의 신약허가신청(NDA)을 접수하고 우선심사 대상으로 지정함. 처방의약품 신청자 수수료법(PDUFA)에 따른 목표 조치일은 2026년 9월 22일임. 주요 규제 이정표 달성에 따라 10% 이상의 주가 영향이 예상됨.
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