uniQure’s AMT-130 Gains Momentum with FDA Support and Promising Clinical Outlook

Patrick Trucchio, an analyst from H.C. Wainwright, reiterated the Buy rating on uniQure (QURE – Research Report). The associated price target remains the same with $70.00.

Patrick Trucchio has given his Buy rating due to a combination of factors, primarily centered around the promising regulatory progress and clinical potential of uniQure’s lead gene therapy candidate, AMT-130, for Huntington’s disease. The FDA has reaffirmed its support for an accelerated approval path for AMT-130, with a Biologics License Application submission expected in the first quarter of 2026, which could lead to approval in the second half of 2026.
The FDA’s agreement on the use of the composite Unified Huntington’s Disease Rating Scale as a registrational endpoint and the planned use of extensive external control data from the ENROLL-HD study further bolster the case for AMT-130’s potential approval. Additionally, the agency’s concurrence on the manufacturing process validation using prior experience from another gene therapy product adds confidence in the production readiness of AMT-130. These elements, combined with a favorable valuation model and a high probability of success, underpin Trucchio’s Buy rating and the $70 price target for uniQure’s stock.

Trucchio covers the Healthcare sector, focusing on stocks such as uniQure, Alnylam Pharma, and Altimmune. According to TipRanks, Trucchio has an average return of -0.3% and a 37.32% success rate on recommended stocks.

In another report released on May 29, Stifel Nicolaus also maintained a Buy rating on the stock with a $30.00 price target.