uniQure N.V. Stock News

Uniqure stock wavered Wednesday after the Food and Drug Administration accepted its application for approval of a Huntington's gene therapy.

Dutch gene therapy developer uniQure said on Wednesday it had applied for U.S. approval of its experimental treatment for Huntington's disease after the FDA reversed ​its earlier position on the drug, sending the company's shares ‌up 5% in premarket trading.

~ Company also announces the submission of a Marketing Authorisation Application for ifezuntirgene inilparvovec in the U.K. ~ ~ Both submissions are supported by the three-year data analysis from the Phase I/II study, in which ifezuntirgene inilparvovec demonstrated a slowing of disease progression ~ LEXINGTON, Mass. and AMSTERDAM, Sept.

~ U.S. and U.K. regulatory submissions for AMT-130 for Huntington's disease on track as planned for the third quarter of 2026 ~ ~ Topline four-year data from the Phase I/II study of AMT-130 expected in September 2026 ~ ~ Reported data from the first cohort in the Phase I/IIa trial of AMT-260 for refractory mesial temporal lobe epilepsy showed early biological signals of therapeutic activity and...

LEXINGTON, Mass. and AMSTERDAM, June 25, 2026 (GLOBE NEWSWIRE) -- uniQure N.V. (Nasdaq: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced the closing of its previously announced underwritten public offering of 5,686,813 ordinary shares at a public offering price of $45.50 per share, which includes 741,758 ordinary sh...

LEXINGTON, Mass. and AMSTERDAM, June 23, 2026 (GLOBE NEWSWIRE) -- uniQure N.V. (Nasdaq: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced the pricing of its previously announced underwritten public offering of 4,945,055 ordinary shares at a public offering price of $45.50 per share. The aggregate gross proceeds to un...

LEXINGTON, Mass. and AMSTERDAM, June 22, 2026 (GLOBE NEWSWIRE) -- uniQure N.V. (Nasdaq: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced that it has commenced a $150 million underwritten public offering of its ordinary shares and, in lieu of ordinary shares to certain investors, pre-funded warrants to purchase its o...