uniQure

uniQure said the FDA confirmed in writing after a Type B meeting that a BLA filing for Huntington’s therapy AMT-130 is appropriate under an accelerated pathway based on existing clinical data. The company beat revenue consensus in Q2 with $5.84m, but reported a higher net loss per share due to increased selling, general and administrative expenses. uniQure plans to file regulatory applications in the US and the UK in Q3 2026, strengthened its balance sheet with a $259m capital raise and extended its cash runway to 2030. The announcements pushed the stock about 6.3% higher in premarket trading. » Más en de.investing.com

UniQure reported Q2 revenue of $5.80 million, exceeding the consensus expectation of $5.47 million, while net loss widened due to higher selling, general and administrative and non‑operating expenses. The revenue increase was driven by higher license income; rising personnel and contractor costs reflect preparations for potential product launches. Through a follow‑on placement, UniQure raised $259 million and says this secures liquidity through 2030; regulatory filings for AMT‑130 are planned for Q3 2026 and topline four‑year data are expected in September 2026. » Más en de.investing.com

In the low‑dose cohort (1x10^12 gc/mL) of the Phase I/IIa study, three of six patients showed a 79–100% reduction in disabling seizures in months 4–6; the other three patients had changes of −33% to +36% versus baseline. No serious adverse events have been reported to date; adverse events were mild to moderate, headaches were most common, and no immunosuppression was required. Recruitment of a higher‑dose cohort (3x10^12 gc/mL) is ongoing, with completion expected mid‑2026 and updated study data planned for H1 2027. The study announcement drove the share price up 67.9% to 46.29 USD and lifted market capitalization to 2.92 billion USD; an analysis by InvestingPro currently rates the stock as overvalued. » Más en de.investing.com