Abeona receives FDA Complete Response Letter for pz-cel BLA due to CMC deficiencies

ABEONA THERAPEUTICS INC.

FDA CRL for pz-cel BLA cites additional CMC information needed; no clinical efficacy/safety deficiencies.
No new clinical trials or clinical data requested by FDA for approval.
Company expects to complete BLA resubmission with requested CMC data in Q3 2024.
PDUFA date of May 25, 2024 will be missed due to proposed timing of data submission.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.