uniQure (QURE) stock is ripping higher this morning after the biopharmaceutical firm announced a major regulatory breakthrough with the FDA for its Huntington’s disease gene therapy AMT-130.
As investors cheered the disclosure, QURE pushed past its key moving averages (MAs) – and its relative strength index (RSI) climbed into the mid-80s, indicating intense buying pressure.
uniQure shares are now trading at more than 5x their price in the first week of March.
Here’s why uniQure stock soared on Wednesday
The sharp increase in QURE share price on Jun. 17 is driven by several key updates from a recent Type B meeting with the FDA.
In its press release, the company said the FDA has agreed that the existing three-year data from uniQure’s Phase I/II clinical study of AMT-130 will be acceptable as the primary basis for a Biologics License Application (BLA) seeking accelerated approval.
QURE now plans on formally submitting the BLA in Q3, and the regulator indicated it would work expeditiously to align on the confirmatory study design prior to submission.
Crucially, the FDA won’t necessarily require a full, standard sham-surgery-controlled Phase 3 trial before considering the drug for approval, which shaves years off the commercialization timeline.
Note that uniQure is trading at a year-to-date high of about $47 at the time of writing.
The reasons for outsized reaction in QURE shares
uniQure stock soared on Wednesday morning as the aforementioned announcement “completely” reverses a devastating regulatory setback from early 2026.
Back then, the FDA had unexpectedly walked back prior guidance and rejected the use of an external control group as the main efficacy comparator, causing the firm’s share price to crash to around $9.
By restoring the accelerated approval pathway that investors had originally hoped for, the regulator has put AMT-130 back on track to potentially become the “first disease-modifying treatment” for Huntington’s.
Notably, the breakthrough is also lifting sympathy plays in the biopharmaceutical sector today – specifically ClearPoint Neuro (CLPT), whose surgical navigation system is used to administer the therapy.
How to play uniQure at current levels?
With QURE stock now trading at year-to-date highs, all eyes turn to the third quarter of the current year for the formal BLA submission.
However, short-term traders must still practice exercise caution: the near-vertical rally has pushed its RSI deep into overbought territory, signaling that a brief period of consolidation or profit-taking could be on the horizon before the next leg higher.
For long-term investors, though, the focus remains squarely on execution. If the US FDA grants accelerated approval, it opens up a massive, untapped commercial market for Huntington’s disease.
In the meantime, expect heightened volatility as Wall Street firms rerate Amsterdam-headquartered uniQure NV to reflect a vastly accelerated, lower-cost path to commercialization.
The post What made uniQure stock nearly double on Wednesday? appeared first on Invezz
