stifel reiterates buy rating on uniQure stock after CEO meeting

On Thursday, Stifel analysts reiterated a Buy rating and maintained a $30.00 price target on uniQure BV (NASDAQ:QURE) stock, which currently trades at $14.96. According to InvestingPro data, analyst targets range from $13.18 to $69.92, with 7 analysts recently revising their earnings expectations upward. This decision follows a recent meeting with uniQure’s leadership, including CEO Matt Kapusta, CMO Walid Abi-Saab, and IR Chiara Russo.

The analysts expressed their confidence in the company’s interactions with the FDA. They are optimistic about the upcoming 3-year data for AMT-130, a treatment for Huntington’s disease, expected in the late third quarter of 2025. This data is anticipated to support a Biologics License Application (BLA) submission. The company’s development efforts come amid challenging financial metrics, with InvestingPro data showing rapid cash burn and negative EBITDA of -$157.58M in the last twelve months.

During the meeting, several topics were discussed, such as the AMT-130 Statistical Analysis Plan (SAP) and the relevance of the ENROLL-HD natural history study as a comparator. The discussions also covered uniQure’s regulatory interactions and a qualitative bar for success in the upcoming data update.

The commercial positioning of AMT-130 was also a focal point, including the potential patient pool size and the logistics of the treatment, which are not seen as significant barriers to patient uptake. With a market capitalization of $819.04 million and strong liquidity position (current ratio of 11.99), the analysts view the stock as an attractive entry point. The stock has demonstrated remarkable performance, gaining over 175% in the past year despite current profitability challenges.

In other recent news, uniQure has made significant strides with its gene therapy candidate, AMT-130, for Huntington’s disease. The company recently held Type B meetings with the FDA, where they aligned on key aspects of their Biologics License Application, expected in early 2026. The FDA has shown support for an accelerated approval pathway, which could lead to potential approval in the second half of 2026. Additionally, uniQure received the FDA’s Breakthrough Therapy designation for AMT-130, which aims to expedite its development and review process. This designation is supported by promising data from ongoing Phase I/II trials, indicating that AMT-130 could slow disease progression. H.C. Wainwright analysts have reaffirmed their Buy rating on uniQure, maintaining a $70 price target. They emphasize AMT-130 as a key value driver and highlight the company’s robust financial position. Furthermore, uniQure is preparing to submit updated analysis and manufacturing plans to the FDA in 2025, with top-line data from the Phase I/II study expected in the third quarter of 2025. These developments reflect uniQure’s progress and potential impact on the treatment landscape for Huntington’s disease.

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