share_log

FDA Rejects Approval Of Abeona Therapeutics' Skin Disorder Treatment, Shares Sink

FDA Rejects Approval Of Abeona Therapeutics' Skin Disorder Treatment, Shares Sink

美國食品藥品管理局拒絕批准Abeona Therapeutics的皮膚病治療,股價下跌
Benzinga ·  04/23 09:43

On Monday, Abeona Therapeutics Inc (NASDAQ:ABEO) announced a regulatory update for prademagene zamikeracel (pz-cel).

週一,Abeona Therapeutics Inc(納斯達克股票代碼:ABEO)宣佈了對prademagene zamikeracel(pz-cel)的監管更新。

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).

美國食品藥品管理局發佈了完整回覆信(CRL),以回應該公司爲治療隱性營養不良性大皰性表皮鬆解症(RDEB)患者而提出的pz-cel的生物製劑許可申請(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與美國食品藥品管理局完成的後期週期審查會議之後發佈的。

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.

在後期週期審查會議和隨後的信息請求中,美國食品和藥物管理局指出,滿足化學制造與控制(CMC)要求需要某些額外信息。

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.

作爲回應,該公司向美國食品和藥物管理局提交了計劃,承諾在BLA批准之前提供CMC數據,並在2024年中期批准後提供完整的驗證報告。

In addition, the company discussed these plans with the FDA in a subsequent informal meeting.

此外,該公司在隨後的非正式會議上與美國食品和藥物管理局討論了這些計劃。

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.

美國食品和藥物管理局在CRL中表示,Abeona提交數據的擬議時間將需要更長的時間才能讓FDA在PDUFA的2024年5月25日之前完成審查。

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).

滿足CRL中CMC要求所需的信息涉及某些製造和發佈測試方法的驗證要求,包括FDA許可前檢查(PLI)期間觀察到的一些信息。

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沒有發現任何與BLA中的臨床療效或臨床安全數據相關的缺陷,FDA也沒有要求任何新的臨床試驗或臨床數據來支持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 已獲得 FDA 的申請許可,並於 2023 年 11 月獲得 FDA 的優先審查指定。

Price Action: ABEO shares are down 45.10% at $4.04 at the last check Tuesday.

價格走勢:在週二的最後一次檢查中,ABEO股價下跌45.10%,至4.04美元。

Photo via Shutterstock

照片來自 Shutterstock

声明:本內容僅用作提供資訊及教育之目的,不構成對任何特定投資或投資策略的推薦或認可。 更多信息
    搶先評論