QURE Stock Recent News

uniQure (QURE) was a big mover last session on higher-than-average trading volume. The latest trend in earnings estimate revisions might not help the stock continue moving higher in the near term.

uniQure's AMT-130 gene therapy for Huntington's Disease shows promising trial data, leading to significant stock price increases and potential for FDA accelerated approval. QURE's stock has seen volatility but has near-term catalysts like BLA submission and 36-month trial data, suggesting potential for immediate further gains. Despite competition from PTC518, AMT-130's effectiveness and one-time treatment advantage could drive substantial revenue and stock price growth.

uniQure's AMT-130 gene therapy showed an 80% slowing of Disease progression in Huntington's Disease patients in a phase 1/2 study. Financially strong with $448 million in cash, uniQure can fund operations through H2 2027, reducing immediate financial risk. AMT-191 for Fabry Disease and AMT-162 for ALS are also advancing, diversifying uniQure's pipeline and potential market impact.

The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to uniQure N.V.'s QURE AMT-130 for Huntington's disease on Thursday

~ Breakthrough Therapy designation based on clinical evidence from Phase I/II trials showing meaningful slowing of disease progression ~

UniQure (QURE) came out with a quarterly loss of $1.50 per share versus the Zacks Consensus Estimate of a loss of $0.44. This compares to loss of $1.53 per share a year ago.

~ Announced alignment with the U.S. Food and Drug Administration (FDA) on key elements of the Accelerated Approval pathway for AMT-130 in Huntington's disease; Initiated preparations for a potential Biologics License Application (BLA) submission ~

uniQure's stock surged in December due to positive data around its Huntington's disease candidate AMT-130, clearing the way for potential accelerated FDA approval without another trial. The company's gene therapy Hemgenix, approved for hemophilia B, and three new clinical programs, including AMT-191, AMT-162, and AMT-260, bolster its pipeline. Cost-cutting measures and strategic financing have extended uniQure's operating runway through 2Q28, with significant analyst support and price targets up to $70 a share.

uniQure's gene therapy AMT-130 for Huntington's Disease shows promising clinical data, with an 80% reduction in disease progression, positioning it for potential FDA approval. Despite past commercial failures, uniQure's current market cap of ~$715m appears undervalued given AMT-130's estimated peak sales potential of ~$2bn. The company has a solid cash position to fund AMT-130's launch, with $251m in cash and $183m in securities, despite a $100m net loss in the first 9m of 2025.

CSL Limited CSLLY and uniQure Inc QURE announced the four-year results from the pivotal HOPE-B study confirming the long-term durability and safety of a one-time infusion of Hemgenix (etranacogene dezaparvovec-drlb) for adults hemophilia B patients.