uniQure Submits BLA to FDA for Huntington Gene Therapy영어 원문
BLA submitted after FDA reversal; acceptance seen as key catalyst
첫날 -3.4% · 5일 후 -3.8%
이전 이벤트 13건›
실적
실적 발표
첫날 -0.9% · 5일 후 +3.0%
애널리스트
Wolfe Research: 투자의견 상향 → Outperform
첫날 +5.3% · 5일 후 +7.5%
실적
uniQure Q2 Loss Wider Than Expected, Stifel Raises PT to $71영어 원문
Post-Q2, Stifel upgrades/raises PT, focus on AMT-130 regulatory path
첫날 +9.3% · 5일 후 +10.4%
›전개 과정 3회
2026-07-29Earnings imminent; focus on near-term milestones over revenue/EPS
2026-07-29Q2 loss of $1.22/share vs $0.81 expected; revenue misses estimates
2026-07-30Post-Q2, Stifel upgrades/raises PT, focus on AMT-130 regulatory path
8-K 공시
8-K: 실적 공시
첫날 +9.3% · 5일 후 +10.4%
실적
실적 발표
첫날 +9.3% · 5일 후 +10.4%
제품호재
AMT-130 Gets FDA Accelerated Approval Path, Q3 Submissions on Track영어 원문
FDA aligns on potential accelerated approval; US/UK submissions on track for Q3; 4-year data due Sept
첫날 +2.3% · 5일 후 -3.2%
›전개 과정 3회
2026-07-17Multiple sources confirm AMT-130 as core, with FDA feedback and Q3 filing shaping regulatory outlook
2026-07-29Q2 loss of $1.22/share vs consensus $0.81; FDA aligned on accelerated-approval pathway for AMT-130; US/UK submissions on track for Q3 2026
2026-07-29FDA aligns on potential accelerated approval; US/UK submissions on track for Q3; 4-year data due Sept
제품호재
uniQure Focuses on AMT-130, Targeting Q3 2026 Filing영어 원문
Multiple reports confirm AMT-130 as core focus; FDA feedback and Q3 filing plan shape regulatory outlook
첫날 +2.3% · 5일 후 -3.2%
규제호재
Mizuho raises uniQure PT to $68 on FDA meeting, boosted AMT-260 approval conviction영어 원문
Mizuho ups PT to $68 from $35, keeps Outperform, citing recent FDA Type B meeting and increased conviction in AMT-260 accelerated approval
첫날 +78.4% · 5일 후 +2.0%
›전개 과정 4회
2026-06-17uniQure to file BLA in Q3 2026 for Huntington's gene therapy
2026-06-18FDA rescinds previous demand for more data; UniQure seeks accelerated approval; stock surges 78%
2026-06-20AMT-260 shows preliminary efficacy in refractory epilepsy with no treatment-related serious adverse events, adding new evidence to gene therapy pipeline
2026-06-25Mizuho ups PT to $68 from $35, keeps Outperform, citing recent FDA Type B meeting and increased conviction in AMT-260 accelerated approval
8-K 공시
8-K: 중요 계약 체결, 기타 주요 사항
첫날 -0.4% · 5일 후 -7.5%
8-K 공시
8-K: Reg FD 공시, 기타 주요 사항
첫날 -4.1% · 5일 후 +6.8%
애널리스트
Barclays: 투자의견 상향 → Overweight
첫날 -3.9% · 5일 후 +2.6%
8-K 공시
8-K: 기타 주요 사항
첫날 +78.4% · 5일 후 +2.0%
8-K 공시
8-K: 이사·임원 변동, 정관 개정, 주주총회 표결 결과
첫날 +1.1% · 5일 후 +76.0%
①
강세 vs 약세
방향별 정리 · 원문 링크
호재 요인0
아직 항목이 없어요
리스크 요인0
아직 항목이 없어요
최근 2주간 X 신뢰 작성자 의견을 AI가 묶은 주장이며, 수치는 독립 작성자 수다. 언급량은 방향을 예측하지 않는다 · 투자 권유 아님
⑩
토론
첫 댓글을 남겨 보세요
서로 존중 · 의견은 작성자 본인 책임 · 투자 권유 아님
아직 댓글이 없어요.
사실과 의견을 구분해 표시 · 모든 항목 원문 확인 가능 · 본 정보는 투자 권유를 목적으로 하지 않으며, 투자 판단과 그 결과에 대한 책임은 투자자 본인에게 있습니다.
이벤트 흐름
주요 이벤트 · 시간순
15건
제품악재
uniQure의 헌팅턴 유전자 치료제 48개월 데이터, 통계적 유의성 미달
AMT-130은 44% 둔화를 보였으나 유의하지 않았고, 주가는 급락했다
첫날 -37.3% · 현재까지 -4.7%
규제호재
uniQure Submits BLA to FDA for Huntington Gene Therapy영어 원문
BLA submitted after FDA reversal; acceptance seen as key catalyst
첫날 -3.4% · 5일 후 -3.8%
실적
실적 발표
첫날 -0.9% · 5일 후 +3.0%
애널리스트
Wolfe Research: 투자의견 상향 → Outperform
첫날 +5.3% · 5일 후 +7.5%
실적
uniQure Q2 Loss Wider Than Expected, Stifel Raises PT to $71영어 원문
Post-Q2, Stifel upgrades/raises PT, focus on AMT-130 regulatory path
첫날 +9.3% · 5일 후 +10.4%
›전개 과정 3회
2026-07-29Earnings imminent; focus on near-term milestones over revenue/EPS
2026-07-29Q2 loss of $1.22/share vs $0.81 expected; revenue misses estimates
2026-07-30Post-Q2, Stifel upgrades/raises PT, focus on AMT-130 regulatory path
이전 이벤트 10건›
8-K 공시
8-K: 실적 공시
첫날 +9.3% · 5일 후 +10.4%
실적
실적 발표
첫날 +9.3% · 5일 후 +10.4%
제품호재
AMT-130 Gets FDA Accelerated Approval Path, Q3 Submissions on Track영어 원문
FDA aligns on potential accelerated approval; US/UK submissions on track for Q3; 4-year data due Sept
첫날 +2.3% · 5일 후 -3.2%
›전개 과정 3회
2026-07-17Multiple sources confirm AMT-130 as core, with FDA feedback and Q3 filing shaping regulatory outlook
2026-07-29Q2 loss of $1.22/share vs consensus $0.81; FDA aligned on accelerated-approval pathway for AMT-130; US/UK submissions on track for Q3 2026
2026-07-29FDA aligns on potential accelerated approval; US/UK submissions on track for Q3; 4-year data due Sept
제품호재
uniQure Focuses on AMT-130, Targeting Q3 2026 Filing영어 원문
Multiple reports confirm AMT-130 as core focus; FDA feedback and Q3 filing plan shape regulatory outlook
첫날 +2.3% · 5일 후 -3.2%
규제호재
Mizuho raises uniQure PT to $68 on FDA meeting, boosted AMT-260 approval conviction영어 원문
Mizuho ups PT to $68 from $35, keeps Outperform, citing recent FDA Type B meeting and increased conviction in AMT-260 accelerated approval
첫날 +78.4% · 5일 후 +2.0%
›전개 과정 4회
2026-06-17uniQure to file BLA in Q3 2026 for Huntington's gene therapy
2026-06-18FDA rescinds previous demand for more data; UniQure seeks accelerated approval; stock surges 78%
2026-06-20AMT-260 shows preliminary efficacy in refractory epilepsy with no treatment-related serious adverse events, adding new evidence to gene therapy pipeline
2026-06-25Mizuho ups PT to $68 from $35, keeps Outperform, citing recent FDA Type B meeting and increased conviction in AMT-260 accelerated approval
