Market
How will uniQure's stock price change after FDA decision on AMT-130?
2
Resolution / Starting Odds
Increase over 20% • 25%
Increase 0-20% • 25%
No change • 25%
Decrease • 25%
Stock market data from financial platforms like Bloomberg or Yahoo Finance
Story
uniQure Gains FDA Alignment on Accelerated Approval Pathway Using cUHDRS for Huntington's Gene Therapy AMT-130
Dec 10, 2024, 01:04 PM
uniQure ($QURE) announced that it has aligned with the U.S. Food and Drug Administration (FDA) on key elements of an Accelerated Approval pathway for its gene therapy candidate AMT-130 in Huntington’s Disease. The FDA agreed that data from the ongoing Phase I/II studies, when compared to a natural history external control, may serve as the primary basis for a Biologics License Application (BLA) submission under the Accelerated Approval program. Additionally, the composite Unified Huntington's Disease Rating Scale (cUHDRS) may serve as an intermediate clinical endpoint. The company has previously presented 24-month data showing superiority over natural history controls. This regulatory alignment is significant as it could expedite the approval process for AMT-130, potentially offering a much-needed treatment for patients with Huntington's Disease. The announcement led to a substantial increase in uniQure's stock price, which more than doubled in pre-market trading.
View original story
Similar markets
Increase by less than 10% • 25%
Decrease by over 10% • 25%
Increase by over 10% • 25%
Decrease by less than 10% • 25%
Rejection • 25%
Full Approval • 25%
Conditional Approval • 25%
Accelerated Approval • 25%
Other • 25%
Biogen stock stable ±5% • 25%
Biogen stock rises >5% • 25%
Biogen stock falls >5% • 25%
Decrease by less than 10% • 25%
Increase by less than 10% • 25%
Decrease by 10% or more • 25%
Increase by 10% or more • 25%
No improvement • 25%
Moderate improvement • 25%
Significant improvement • 25%
Worsening condition • 25%
Increase by less than 10% • 25%
Decrease • 25%
No significant change • 25%
Increase by more than 10% • 25%
Underperforms biotech index • 25%
No significant change • 25%
Performs in line with biotech index • 25%
Outperforms biotech index • 25%
Decreases by more than 10% • 25%
Increases by 30-50% • 25%
Increases by more than 50% • 25%
Remains stable (±10%) • 25%