1차 출처 기록
중대자문위원회 일정 확정
uniQure, FDA와 AMT-130 BLA 관련 Type A 미팅 일정 확정
uniQure는 헌팅턴병 치료를 위한 유전자 치료제 AMT-130의 BLA 데이터 패키지를 논의하기 위해 FDA와 Type A 미팅을 예정했다. 이번 미팅은 가속승인 경로를 논의하기 위한 것이다. 회사는 공식 미팅 회의록을 받은 후 규제 관련 업데이트를 제공할 예정이다.
핵심 사실
출처 발췌
EX-99.1 2 qure-20260109xex99d1.htm EX-99.1 Exhibit 99.1 uniQure Announces Type A Meeting Scheduled with FDA Lexington, MA and Amsterdam, the Netherlands, January 9, 2026 — uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced a Type A meeting with the U.S. Food and Drug Administration (FDA) has been scheduled to discuss the Biologics License Application (BLA) data package to support accelerated approval of AMT-130, the Company’s investigational gene therapy for the treatment of Huntington’s disease. “We look forward to a constructive discussion with the FDA as we work toward a timely resolution regarding an accelerated approval pathway for AMT-130,” said Matt Kapusta, chief executive off