uniQure stock rating reiterated at Buy by Stifel ahead of key data

Investing.com - Stifel has reiterated its Buy rating and $30.00 price target on uniQure BV (NASDAQ:QURE), according to a research note published Monday. The company, currently trading at $13.86, has seen analyst targets ranging from $13.53 to $71.75, with 7 analysts recently revising their earnings expectations upward according to InvestingPro data.

The firm expressed optimism about the upcoming three-year AMT-130 analysis, which it believes will likely show strong results, followed by a Biologics License Application (BLA) expected in the first quarter of 2026.

Stifel noted that uniQure appears to have established "deep" regulatory alignment with the FDA, suggesting that key issues that might arise during regulatory review have already been discussed and preliminarily addressed.

The research firm acknowledged the FDA is currently in a state of transition, but suggested Huntington’s disease is an area where greater FDA risk tolerance would be logical given the severity of the condition and its impact on adults.

Stifel also highlighted positive key opinion leader (KOL) feedback regarding potential adoption of uniQure’s treatment, while characterizing the stock as "one of the more binary/polarizing stocks" in its coverage universe. The stock has demonstrated strong momentum with a 209% return over the past year, though InvestingPro’s Fair Value analysis suggests the stock is currently fairly valued.

In other recent news, uniQure N.V. announced the outcomes of its 2025 Annual General Meeting of Shareholders, where key proposals such as executive compensation and board reappointments were approved. Shareholders also voted in favor of amending the company’s Share Incentive Plan, increasing the number of shares reserved for issuance. Additionally, Kylie O’Keefe was appointed as Chief Customer and Strategy Officer, with responsibilities including the commercialization strategy for AMT-130, a gene therapy for Huntington’s disease. Stifel analysts reiterated a Buy rating on uniQure stock, expressing confidence in the company’s interactions with the FDA, particularly regarding AMT-130. H.C. Wainwright analysts also reaffirmed a Buy rating following Type B meetings with the FDA, which support an accelerated approval path for AMT-130. UniQure has aligned with the FDA on key aspects of its Biologics License Application for AMT-130, expected to be submitted in early 2026. The company plans to present top-line Phase I/II data later in 2025 as part of its regulatory strategy. These developments highlight uniQure’s ongoing progress in advancing its gene therapy pipeline.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.