BEGIN:VCALENDAR
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-celc-gedatolisib-pdufa-july-2026@catalyst-calendar.local
DTSTAMP:20260601T102424Z
DTSTART:20260717T130000Z
DTEND:20260717T133000Z
SUMMARY:Celcuity gedatolisib HR+/HER2-乳腺癌NDA PDUFA日期
DESCRIPTION:FDA已授予Celcuity gedatolisib NDA优先审评，并设定2026-07-17为PDUFA目标日期，适应症为HR+/HER2-/PIK3CA野生型晚期乳腺癌。该决定可能影响PI3K/mTOR通路、CDK4/6后线组合和乳腺癌靶向治疗竞争预期。\\nImpact score: 70\\nExpected: 审批结果将影响CELC商业化路径，并可能改变乳腺癌后线靶向组合的竞争参照。\\nAffected: CELC(subject\, unknown\, score 88)\; XBI(etf\, mixed\, score 48)\; PFE(peer\, mixed\, score 40)\; NVS(peer\, mixed\, score 40)\\nSources: Celcuity FDA acceptance release: https://ir.celcuity.com/news-releases/news-release-details/celcuity-announces-fda-acceptance-new-drug-application\\nCelcuity Q1 2026 update: https://ir.celcuity.com/news-releases/news-release-details/celcuity-inc-reports-release-first-quarter-2026-financial\\nInformation only. Not investment advice.
URL:https://0.0.0.0:3000/?event=evt-celc-gedatolisib-pdufa-july-2026
CATEGORIES:fda\,US\,FDA\,PDUFA\,breast cancer\,PI3K\,mTOR
SEQUENCE:0
BEGIN:VALARM
TRIGGER:-P1D
ACTION:DISPLAY
DESCRIPTION:Review catalyst preview: Celcuity gedatolisib HR+/HER2-乳腺癌NDA PDUFA日期
END:VALARM
BEGIN:VALARM
TRIGGER:PT24H
ACTION:DISPLAY
DESCRIPTION:Complete post-event review: Celcuity gedatolisib HR+/HER2-乳腺癌NDA PDUFA日期
END:VALARM
END:VEVENT
END:VCALENDAR