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  • FDA to reconsider shock rejection of cell therapy Ebvallo. Could uniQure be next?

FDA to reconsider shock rejection of cell therapy Ebvallo. Could uniQure be next?

  • May 7, 2026

After a surprise rejection in January, the FDA has agreed to reconsider a T-cell therapy based on the same single-arm trial that the agency had previously found problematic. The case could reignite investors’ hope of a potential reversal for uniQure’s high-profile gene therapy, too.

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