biotech
<a href="https://www.fiercebiotech.com/pharma/fda-reconsider-surprisingly-rejected-cell-therapy-ebvallo-could-uniqure-be-next" hreflang="en">FDA to reconsider shock rejection of cell therapy Ebvallo. Could uniQure be next?</a>
FierceBiotech
May 11, 2026 · 25s listen
Listen · FierceBiotech
<a href="https://www.fiercebiotech.com/pharma/fda-reconsider-surprisingly-rejected-cell-therapy-ebvallo-could-uniqure-be-next" hreflang="en">FDA to reconsider shock rejection of cell therapy Ebvallo. Could uniQure be next?</a>
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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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