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.

iBio, Inc. Common Stock (IBIO): Among Stocks Insiders Were Buying In Q1 2025

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. 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.

READ NEXT:  Cathie Wood’s Stock Portfolio: Top 10 Stocks to Buy and 30 Most Fantastic Stocks Every Investor Should Pay Attention To.

This article is originally published at Insider Monkey.