uniQure (QURE) on Tuesday announced that the company reached an agreement with the FDA on key elements of an Accelerated Approval pathway for AMT-130 in Huntington’s disease, and data from the Phase 1/2 studies vs. natural history external control could serve as the primary basis for a biologics license application for accelerated approval, Cantor Fitzgerald analyst Kristen Kluska tells investors in a research note, adding that this is a best case scenario for uniQure. The firm thinks this also likely bodes well for PTC Therapeutics (PTCT), who is meeting with the FDA this month to discuss the path forward in a Type C meeting, and Cantor would be aggressive buyers on both Overweight-rated stocks. While there could be room for both therapies, the firm sees PTC’s PTC510 as best-positioned at this time.
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