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Huntington's disease, FDA

Hosted on MSN · 8h

QURE Soars on FDA Alignment for Speedy Approval of Huntington's Drug

Qure N.V. QURE surged 109.7% after it announced reaching alignment with the FDA on key elements of an accelerated approval pathway for AMT-130, a one-time administered investigational gene therapy, which is being developed to treat Huntington’s disease.

BioPharma Dive · 1d

UniQure shares soar on chance of speedy approval for Huntington’s therapy

The company now says that, during a recent meeting with the FDA, the two parties agreed on some key elements for an accelerated approval application.

Business Insider · 1d

FDA Agrees On Accelerated Approval Pathway For AMT-130 In Huntington's Disease; Stock Up 89%

Gene therapy company uniQure N.V. (QURE) announced Tuesday that the company reached agreement with the U.S. Food and Drug

Hosted on MSN1d

uniQure Stock Hits 18-Month High After FDA Agreement Clears Pathway For Huntington’s Treatment: Retail Gets More Optimistic

Shares of gene therapy company uniQure more than doubled on Tuesday before trimming some gains, reaching their highest levels ...

1d

uniQure's AMT-130: A Bold Step For Huntington's, But Not Without Hurdles

Qure's AMT-130 shows promising results for Huntington’s disease. Learn why QURE stock faces commercialization challenges ...

UniQure Clears Path to Accelerated Approval for Huntington’s Gene Therapy

In a Type B meeting, the FDA signified that it will allow uniQure to use a natural history control, the composite Unified ...

News Medical on MSN7d

Heart medication may slow the progression of Huntington's disease

Research indicates β-blockers may reduce the risk of motor diagnosis and slow symptom progression in Huntington's disease, ...

1d

uniQure Announces Alignment with FDA on Key Elements of Accelerated Approval Pathway for AMT-130 in Huntington’s Disease

U.S. Food and Drug Administration (FDA) agrees that data from ongoing Phase I/II studies compared to a natural history external control may ...

Novartis to pay $1 billion upfront to license Huntington’s drug from PTC

Novartis is paying $1 billion upfront in a licensing deal for an experimental Huntington’s disease treatment from PTC ...

Psychology Today13d

How Huntington's Disease Helped Me Find My Magic

The Wicked Witch of the West and I have something in common: We both use our fatal flaws to our advantage—for her, her green ...

9don MSN

Common heart drug may slow progression of Huntington's disease

A common heart drug may slow the progression of Huntington's disease (HD), according to a new study by University of Iowa ...

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