uniQure N.V.
A. Risk Factors , and all of the other information contained in this Annual Report on Form 10-K before investing in our ordinary shares. These risks include, but are not limited to, the following: We …
A. Risk Factors , and all of the other information contained in this Annual Report on Form 10-K before investing in our ordinary shares. These risks include, but are not limited to, the following: We are dependent on the success of our lead product candidate, AMT-130, for the treatment of Huntington’s disease. A failure of AMT-130 in clinical development, including inability to demonstrate sufficient safety or efficacy, or challenges associated with its regulatory approval, manufacturing or commercialization could adversely affect our business. We have encountered and may encounter future delays in and impediments to the progress of our clinical trials or fail to demonstrate the safety and efficacy of our product candidates. Our progress in early-stage clinical trials may not be predictive of long-term efficacy in late-stage clinical trials, and our progress in trials for one product candidate may not be predictive of progress in trials for other product candidates. If we are unable to successfully commercialize our product candidates or experience significant delays in doing so, including as result of a BLA or other key regulatory filings being delayed or rejected, our business could be materially harmed. Any approved gene therapy we seek to commercialize may fail to achieve the degree of market acceptance by physicians, patients, third party payers and others in the medical community necessary for commercial success.
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