Abeona Therapeutics (NASDAQ: ABEO) experienced a significant drop of over half of its stock price on October 30, 2024, which can be attributed to the following factors1:
- FDA Complete Response Letter: The company received a Complete Response Letter (CRL) from the FDA regarding its Biologics License Application (BLA) for pz-cel. This letter typically indicates that the FDA has concerns about the application, which can lead to delays or rejection of the drug candidate.
- Biologics License Application Resubmission: Despite the setback, Abeona Therapeutics announced the resubmission of its BLA to the FDA on October 29, 2024. This action suggests that the company is addressing the issues raised in the CRL and is confident in the resubmission. However, the market may have reacted negatively due to uncertainty surrounding the FDA review process and potential delays in the approval timeline23.
In summary, the decline in Abeona Therapeutics' stock price today is likely a result of the FDA Complete Response Letter and the subsequent resubmission of the Biologics License Application.
10/30/2024 05:19pm
