Progress on AMT-130 Halts uniQure N.V.’s (QURE) Downtrend

uniQure N.V. (NASDAQ:QURE) is among the hidden multibagger stocks to invest in. The company received final meeting notes from the FDA on December 4 regarding its pre-Biologics License Application (BLA) for AMT-130. uniQure is developing AMT-130, a gene therapy for the treatment of Huntington’s disease. Based on the FDA’s final notes, the data from the phase I/II studies of AMT-130 are unlikely to be accepted as the key evidence required for a BLA submission.

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As a result of this feedback, the stock fell sharply. The company said that it is analyzing the feedback and planning to request another meeting with the FDA. QURE intends to hold a follow-up meeting in the first quarter of 2026.

Soon after the FDA’s remarks, a positive development came in the form of an analyst upgrade. On December 5, QURE received a Buy rating from a Stifel Nicolaus analyst, Paul Matteis. He assigned the stock a price target of $50.

Concerns remain about the stock, as evident in Leerink Partners’ report before the rating mentioned above. On November 10, the research house issued a report, lowering its earnings estimates. As per the report, Analyst J. Schwartz now anticipates EPS of  -$3.97 for FY2025, which is meaningfully below the previous forecast of -$1.71.

In addition to FY2025 EPS estimates, analysts also lowered their earnings expectations for the next few quarters. They now expect the firm to report -$1.05 per share, -$1.12 per share, -$1.18 per share, and -$1.07 per share in Q4 2025, Q1 2026, Q2 2026, and Q3 2026, respectively. For the full year 2027, the company’s estimated EPS is -$1.37. This downward revision in earnings estimates came after UniQURE posted a loss of $1.38 per share in its latest quarter, released on November 10.

uniQure N.V. (NASDAQ:QURE) is a US-based biotechnology firm developing treatments for patients affected by rare and serious diseases. The company’s HEMGENIX treatment helps people with hemophilia B to produce factor IX, lowering their risk of bleeding. It is also developing AMT-260, AMT-130, AMT-162, and AMT-191. QURE is based in Amsterdam, the Netherlands.

While we acknowledge the risk and potential of QURE as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and doing so within a shorter time frame. If you are looking for an AI stock that is more promising than QURE and that has 10,000% upside potential, check out our report about this cheapest AI stock.

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Disclosure: None. This article is originally published at Insider Monkey.