By David Bautz, PhD
READ THE FULL ABEO RESEARCH REPORT
FDA Inspection and BLA Mid-Cycle Review Meeting Completed
On February 1, 2024, Abeona Therapeutics, Inc. (NASDAQ:ABEO) announced that, as part of the review of the Biologics License Application (BLA) for prademagene zamikeracel (pz-cel; formerly EB-101), the U.S. Food and Drug Administration (FDA) completed both a Bioresearch Monitoring (BIMO) inspection and the BLA mid-cycle review meeting. 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. This is separate from the inspection of the manufacturing facility, which is expected to take place at the end of February 2024.
The BIMO inspection took place from January 22, 2024 to January 24, 2024. The FDA inspector did not issue any observations or FDA Form 483s during the inspection. An FDA Form 483 is issued when an investigator observes condition(s) that in their judgement would indicate that there are “objectionable conditions” that need to be amended. The formal report from the FDA based on the BIMO inspection will be issued at a later date.
Following the BIMO inspection, the company conducted the BLA mid-cycle review meeting with the FDA. During that meeting, the FDA reaffirmed that it does not plan on holding an Advisory Committee meeting for pz-cel. In addition, the FDA noted that Risk Evaluation and Mitigation Strategies (REMS) are not anticipated for pz-cel. Lastly, the FDA reconfirmed the PDUFA target action date of May 24, 2024.
The conclusion of the BIMO inspection at Abeona’s headquarters in Cleveland without the issuance of any observations or FDA Form 483s is great news for the company and the FDA remains on track to issue a decision on the BLA for pz-cel on or before the PDUFA date of May 25, 2024. We have advanced our DCF model ahead by one year, which has slightly increased our valuation to $12 per share.
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