uniQure: Worst Case Scenario Becomes Reality

2026-03-03 22:22:59 ET

uniQure's ( QURE ) stock plummeted again on Monday after the company announced that it did not make any progress in its Type A meeting with the FDA about its AMT-130 Huntington's disease treatment. If anything, the FDA's position appears to have hardened considerably, and the only path forward now appears to be a Phase III randomized, double-blind, sham surgery-controlled study. This would not be ethical, though, and at this point it is not even clear whether it is really feasible. As a result, I actually think that it is more likely that AMT-130 never makes it to market in the US than a sham surgery-controlled Phase III trial occurring....

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