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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