Truist notes that uniQure (QURE) has shared that based on recent pre-BLA mtg, the FDA is unlikely to approve AMT-130 with current data package. Based on the firm’s prior conversations with thought leaders in Huntington’s disease, this may, at least in part, be related to the use of ENROLL-HD natural history as matched control. This is a unique issue for uniQure with no read-throughs to PTC Therapeutics (PTCT) and Wave Life Sciences’ (WVE) HD programs, in Truit’s view.
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