$uniQure NV (QURE.US)$Wow! gettin closer to actually closing that gap on daily! Color me impressed! Hehehe! Be even more impressed ifn you actually make 19.44? But its looking possible if buy side stays strong! NFA just thinking outloud
$uniQure NV (QURE.US)$UniQure Reaches Agreement With FDA On Key Elements Of An Accelerated Approval Pathway For AMT-130 Benzinga· 3 mins ago -As part of uniQure's Regenerative Medicine Advanced Therapy (RMAT) Type B meeting held in late November, the FDA agreed that data from the ongoing Phase I/II studies, compared to a natural history external control, may serve as the primary basis for a BLA submission under the Accelerated Approval pathway, avoiding the need for an additional pre-submiss...
$uniQure NV (QURE.US)$ uniQure Announces Alignment with FDA on Key Elements of Accelerated Approval Pathway for AMT-130 in Huntington’s Disease uniQure has reached an agreement with the FDA on key elements for an Accelerated Approval pathway for AMT-130, their Huntington's disease treatment. The FDA agreed that data from ongoing Phase I/II studies compared to natural history external control can serve as the primary basis for a Biologics License Application (BLA), eliminating the need for ad...
$uniQure NV (QURE.US)$uniQure Announces Dosing of First Patient in GenTLE Phase I/IIa Clinical Trial of AMT-260 for the Treatment of Refractory Mesial Temporal Lobe Epilepsy 4 MINUTES AGO, 7:05 AM EST VIA GLOBENEWSWIRE
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Benzinga· 3 mins ago
-As part of uniQure's Regenerative Medicine Advanced Therapy (RMAT) Type B meeting held in late November, the FDA agreed that data from the ongoing Phase I/II studies, compared to a natural history external control, may serve as the primary basis for a BLA submission under the Accelerated Approval pathway, avoiding the need for an additional pre-submiss...
uniQure Announces Alignment with FDA on Key Elements of Accelerated Approval Pathway for AMT-130 in Huntington’s Disease
uniQure has reached an agreement with the FDA on key elements for an Accelerated Approval pathway for AMT-130, their Huntington's disease treatment. The FDA agreed that data from ongoing Phase I/II studies compared to natural history external control can serve as the primary basis for a Biologics License Application (BLA), eliminating the need for ad...
4 MINUTES AGO, 7:05 AM EST
VIA GLOBENEWSWIRE
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