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VERSION:2.0
PRODID:-//Catalyst Calendar//CN-US Event Research//ZH
CALSCALE:GREGORIAN
METHOD:PUBLISH
X-WR-CALNAME:Catalyst Calendar
X-WR-CALDESC:Market-moving event research, reminders and post-event review.
BEGIN:VEVENT
UID:evt-fda-ultragenyx-dtx401-gsdia-pdufa-august-2026@catalyst-calendar.local
DTSTAMP:20260720T200647Z
DTSTART:20260824T035900Z
DTEND:20260824T042900Z
SUMMARY:Ultragenyx DTX401 GSDIa基因治疗PDUFA窗口
DESCRIPTION:FDA已接受Ultragenyx DTX401 AAV基因治疗用于Glycogen Storage Disease Type Ia的BLA并授予优先审评，PDUFA日期为2026年8月23日；若获批，将验证AAV代谢病基因治疗商业化和制造审评路径。\\nImpact score: 67\\nExpected: FDA批准、CRL或延期；重点关注制造、耐久性、安全性和是否需要上市后研究。\\nAffected: RARE(subject\, unknown\, score 82)\; QURE(peer\, mixed\, score 52)\; XBI(etf\, mixed\, score 52)\; SRPT(peer\, mixed\, score 50)\; CRSP(theme\, mixed\, score 44)\\nSources: Ultragenyx FDA acceptance release: https://ir.ultragenyx.com/news-releases/news-release-details/ultragenyx-announces-us-fda-acceptance-and-priority-review\\nUltragenyx DTX401 rolling submission: https://ir.ultragenyx.com/news-releases/news-release-details/ultragenyx-completes-rolling-submission-biologics-license\\nClinicalTrials.gov GlucoGene: https://clinicaltrials.gov/study/NCT05139316\\nInformation only. Not investment advice.
URL:https://0.0.0.0:3000/?event=evt-fda-ultragenyx-dtx401-gsdia-pdufa-august-2026
CATEGORIES:fda\,US\,FDA\,PDUFA\,AAV\,基因治疗\,罕见病\,gene therapy\,rare disease
SEQUENCE:0
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DESCRIPTION:Review catalyst preview: Ultragenyx DTX401 GSDIa基因治疗PDUFA窗口
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ACTION:DISPLAY
DESCRIPTION:Complete post-event review: Ultragenyx DTX401 GSDIa基因治疗PDUFA窗口
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