uniQure stock falls 50% after FDA rejects gene therapy BLA submission.

uniQure's stock price fell over 50% after the FDA notified the company that data for its AMT-130 gene therapy for Huntington's disease did not provide sufficient evidence to support its BLA submission. The FDA no longer agrees that data from the Phase I/II studies may be adequate for a BLA submission, and the timing of the submission is unclear. Kessler Topaz Meltzer & Check is investigating potential violations of federal securities laws on behalf of investors.