uniQure Stock Plunges 40% After FDA Shocker - uniQure (NASDAQ:QURE)

UniQure says FDA wants another study of Huntington’s gene therapy

Agency staff "strongly recommended" a sham surgery-controlled trial be conducted before an approval filing, a stance one analyst called a "worst case scenario" for UniQure.

New FDA knockback hits uniQure and Huntington patients hard

uniQure looks like it may have to run another trial of its Huntington's disease gene therapy AMT-130, delaying the highly anticipated programme

UniQure plans to seek approval for Huntington’s therapy still blocked by FDA

The company says the Food and Drug Administration is insisting a completed trial is insufficient to seek clearance of the drug, AMT-130.

uniQure Stock Plunges 40% After FDA Shocker - uniQure (NASDAQ:QURE)

FDA urges uniQure to run a new trial for AMT-130, sending QURE shares down nearly 40% in premarket trading.

UniQure says FDA prefers randomized trial for Huntington's treatment

UniQure's stock dropped again Monday morning after it received negative feedback from the FDA on its Huntington’s disease program. Regulators do not believe that the application for the program, known as AMT-130, is “sufficient” to ...