- On track for PDUFA target action date of May 25, 2024 - CLEVELAND, Feb. 01, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced, as part of the review process by the U.S. Food and Drug Administration (FDA) for the Biologics License Application (BLA) for pz-cel (prademagene zamikeracel) for recessive dystrophic epidermolysis bullosa (RDEB), completion by the FDA of both a Bioresearch Monitoring (BIMO) inspection of Abeona and the BLA mid-cycle review meeting.

-PDUFA目标行动日期为2024年5月25日-克利夫兰，2024年2月1日（环球通讯社）-Abeona Therapeutics Inc.（纳斯达克：ABEO）今天宣布，作为美国食品和药物管理局（FDA）对pz-cel（prademagene zamikeracel）治疗隐性营养不良性大疱性表皮松解症（RDEB）的生物制剂许可证申请（BLA）审查过程的一部分，FDA完成了对Abeona的生物研究监测（BIMO）检查和BLA中期审查会议。

The BIMO inspection was conducted from January 22, 2024 through January 24, 2024 at Abeona’s headquarters in Cleveland, Ohio, and reviewed the conduct and practices that pertain to the clinical studies of pz-cel. The FDA inspector did not issue any observations or FDA Form 483s during the inspection.

BIMO检查于2024年1月22日至2024年1月24日在俄亥俄州克利夫兰的Abeona总部进行，并审查了与pz cel临床研究相关的行为和实践。FDA检查员在检查期间没有发布任何观察结果或FDA表格483s。

The formal report from the FDA regarding the BIMO inspection will be received at a later date. FDA's BIMO program is a comprehensive program of on-site inspections, data audits, and remote regulatory assessments designed to monitor all aspects of the conduct and reporting of FDA regulated research. The BIMO program was established to assure the quality and integrity of data submitted to the agency in support of new product approvals and marketing applications.

稍后将收到FDA关于BIMO检查的正式报告。FDA的BIMO计划是一项现场检查、数据审计和远程监管评估的综合计划，旨在监测FDA监管研究的行为和报告的各个方面。建立BIMO计划是为了确保提交给该机构的数据的质量和完整性，以支持新产品批准和营销应用。

Following the BIMO inspection, the BLA mid-cycle review meeting took place on January 25, 2024. The FDA reaffirmed its earlier indication that it does not currently plan to convene an Advisory Committee for pz-cel. In addition, the FDA advised that Risk Evaluation and Mitigation Strategies (REMS) are not anticipated for the pz-cel application at this time, though application review is ongoing, and reconfirmed the PDUFA target action date of May 25, 2024, on which an approval decision on the pz-cel BLA is expected.

BIMO检查后，BLA中期审查会议于2024年1月25日举行。FDA重申其先前的指示，即目前不计划为pz cel召集咨询委员会。此外，美国食品和药物管理局（FDA）建议，虽然正在进行申请审查，但目前预计pz cel申请不会进行风险评估和缓解策略（REMS），并再次确认PDUFA的目标行动日期为2024年5月25日，预计将对pz cel BLA作出批准决定。

“The Abeona team .

“Abeona团队。