On November 14, 2024, Abeona Therapeutics, Inc. (ABEO) announced financial results for the third quarter of 2024 and provided a business update. The company recently announced that the U.S. FDA has accepted the re-submission of the Biologics License Application (BLA) for pz-cel and set a PDUFA target action date of April 29, 2025. The acceptance of the BLA by the FDA indicates that the resubmission includes all the necessary information that was found to be deficient in the original BLA filing and we are confident that the company has addressed all the issues identified in the CRL and the pre-license inspection. The company continues pre-commercialization activities with a goal of being ready to start treating patients approximately two to three months post approval. Following an upward adjustment to our estimated price per treatment for pz-cel, our valuation has increase to $9.50.
