FDA wants more data from Abeona Therapeutics as it pushes for BLA
Abeona Therapeutics pushed back plans to submit its gene therapy for a rare skin condition after the FDA asked the company for more data about how the treatment is manufactured.
The Cleveland-based biotech said late last year that it planned to file its BLA in the second quarter of this year. But Abeona said Friday that it is requesting that a pre-BLA meeting date with the FDA be rescheduled for August following feedback from the regulator. It now plans to submit EB-101 in the third quarter of the year.
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