FDA Rejects Approval Of Abeona Therapeutics' Skin Disorder Treatment, Shares Sink
FDA Rejects Approval Of Abeona Therapeutics' Skin Disorder Treatment, Shares Sink
On Monday, Abeona Therapeutics Inc (NASDAQ:ABEO) announced a regulatory update for prademagene zamikeracel (pz-cel).
周一，Abeona Therapeutics Inc（纳斯达克股票代码：ABEO）宣布了对prademagene zamikeracel（pz-cel）的监管更新。
The FDA has issued a Complete Response Letter (CRL) in response to the company's Biologics License Application (BLA) for pz-cel for the treatment of patients with recessive dystrophic epidermolysis bullosa (RDEB).
美国食品药品管理局发布了完整回复信（CRL），以回应该公司为治疗隐性营养不良性大疱性表皮松解症（RDEB）患者而提出的pz-cel的生物制剂许可申请（BLA）。
The CRL follows the completion of Abeona's Late Cycle Review Meeting with the FDA in March 2024.
CRL是在2024年3月Abeona与美国食品药品管理局完成的后期周期审查会议之后发布的。
At the Late Cycle Review Meeting and in a subsequent information request, the FDA noted that certain additional information needed to satisfy Chemistry Manufacturing and Controls (CMC) requirements.
在后期周期审查会议和随后的信息请求中，美国食品和药物管理局指出，满足化学制造与控制（CMC）要求需要某些额外信息。
In response, the company submitted plans to the FDA with the commitment to provide CMC data prior to BLA approval and full validation reports after approval in mid-2024.
作为回应，该公司向美国食品和药物管理局提交了计划，承诺在BLA批准之前提供CMC数据，并在2024年中期批准后提供完整的验证报告。
In addition, the company discussed these plans with the FDA in a subsequent informal meeting.
此外，该公司在随后的非正式会议上与美国食品和药物管理局讨论了这些计划。
In the CRL, the FDA indicated that the proposed timing of the data submission by Abeona would require more time for the FDA to complete its review by the May 25, 2024, PDUFA date.
美国食品和药物管理局在CRL中表示，Abeona提交数据的拟议时间将需要更长的时间才能让FDA在PDUFA的2024年5月25日之前完成审查。
The information needed to satisfy the CMC requests in the CRL pertains to validation requirements for certain manufacturing and release testing methods, including some captured in the observations during the FDA's pre-license inspection (PLI).
满足CRL中CMC要求所需的信息涉及某些制造和发布测试方法的验证要求，包括FDA许可前检查（PLI）期间观察到的一些信息。
The CRL did not identify any deficiencies related to the clinical efficacy or clinical safety data in the BLA, and the FDA did not request any new clinical trials or clinical data to support the approval of pz-cel.
CRL没有发现任何与BLA中的临床疗效或临床安全数据相关的缺陷，FDA也没有要求任何新的临床试验或临床数据来支持pz-cel的批准。
The BLA for pz-cel was accepted for filing and granted priority review designation by the FDA in November 2023.
pz-cel 的 BLA 已获得 FDA 的申请许可，并于 2023 年 11 月获得 FDA 的优先审查指定。
Price Action: ABEO shares are down 45.10% at $4.04 at the last check Tuesday.
价格走势：在周二的最后一次检查中，ABEO股价下跌45.10％，至4.04美元。
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