Portfolio Holding uniQure N.V. Announces Filing Plans with U.S. Food & Drug Administration

Summary by AI ^BETAClose X

Worldwide Healthcare Trust PLC announced that its portfolio holding, uniQure N.V., received positive feedback from the U.S. Food and Drug Administration regarding the 3-year analysis from its Phase I/II study for AMT-130 in Huntington's disease, paving the way for a Biologics License Application. This development led to a significant 78.4% appreciation in uniQure's share price to U.S.$48.16. At the time of the announcement, Worldwide Healthcare Trust's holding in uniQure represented 1.10% of its net asset value, which subsequently increased to 1.93% following the share price rise.

Disclaimer*

18 June 2026

WORLDWIDE HEALTHCARE TRUST PLC

("WWH" or the "Company")

Portfolio Holding uniQure N.V. Announces Filing Plans with U.S. Food & Drug Administration

The Company notes the announcement on Wednesday, 17 June 2026 that uniQure N.V ("uniQure"), during a recent Type B meeting with the U.S. Food and Drug Administration (FDA), the FDA communicated that the 3-year analysis from the Phase I/II study would be acceptable as the primary basis of a Biologics License Application (BLA) for the accelerated approval of AMT-130 in Huntington's disease (HD). This marks an important shift for the FDA, creating a pathway for a near-term regulatory filing that was otherwise not available under previous leadership of the FDA.

AMT-130 is an investigational treatment and is the first one-time administered gene therapy to enter clinical testing for the treatment of HD. AMT-130 has been granted Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA - the first RMAT designation for HD - as well as Breakthrough Therapy designation and Fast Track designation.

The Company's holding in uniQure represented 1.10% of the Company's net asset value (NAV) at the time of the announcement. In response to this development, the share price appreciated 78.4% to U.S.$48.16 (compared to a cost base of U.S.$16.74 which reflects multiple purchases made in March 2026) and represented 1.93% of NAV as of the close on 17 June 2026.

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