Regulatory DelaysThe assumption for AMT-130 market entry is pushed from 2027 to 2028 due to FDA's reliability concerns.
Study RequirementsIt's possible that QURE will need an entirely new study, which would have a lot of risk, take a long time, and may lead to more downside for the stock.
Submission UncertaintyThe path to and timing of BLA submission for AMT-130 are still unclear, suggesting the stock will remain under pressure until there is clarity.