Abeona Therapeutics Reports Third Quarter 2024 Financial Results and Recent Corporate Updates

Abeona Therapeutics Inc. (NASDAQ: ABEO) recently released its financial results for the third quarter of 2024 along with notable corporate updates. The company’s key focus has been on the progress of its Biologics License Application (BLA) resubmission for pz-cel, an autologous cell-based gene therapy developed for recessive dystrophic epidermolysis bullosa (RDEB).

The company highlighted several significant achievements and advancements in its recent operations:

Pz-cel for RDEB:
– Completed a Type A meeting with the FDA in August 2024, aligning on the content for the BLA resubmission for pz-cel to address Chemistry Manufacturing and Controls (CMC) requirements specified in the Complete Response Letter issued in April 2024.
– Secured product-specific procedure codes and favorable Medicare reimbursement decisions for pz-cel, indicating progress towards potential commercialization.
– Resubmitted the BLA for pz-cel to the FDA in October 2024.
– Obtained new patents that cover the use of pz-cel for RDEB treatment.
– FDA accepted the BLA resubmission with a PDUFA target action date set for April 29, 2025.

Other Updates:
– Agreement with Beacon Therapeutics for evaluating AAV204 capsid for potential use in AAV gene therapies for ophthalmology indications.
– Partnered program with Ultragenyx making progress with a pre-BLA meeting for UX111 AAV gene therapy for Sanfilippo syndrome type A.

Financial Results:
As of September 30, 2024, the company reported total cash, cash equivalents, short-term investments, and restricted cash of $110.0 million.
Operational funds expected to last into 2026, excluding potential revenue from commercial sales of pz-cel or proceeds from a Priority Review Voucher.
Research and development expenses increased to $8.9 million for the quarter, while general and administrative expenses rose to $6.4 million.

Overall, Abeona Therapeutics is making significant strides in its development and commercialization efforts, particularly in advancing pz-cel towards potential FDA approval for RDEB treatment. The company is focused on expanding its capabilities, securing regulatory approvals, and ensuring patient access to innovative therapies.

Investors can access further details through Abeona Therapeutics’ official press release and financial statements for the quarter. Additionally, a conference call and webcast discussing the results are scheduled for Thursday, November 14, 2024, at 8:30 a.m. ET.

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This article is based on the 8-K SEC filing and subsequent Exhibit 99.1 by Abeona Therapeutics Inc. For more detailed financial information, please refer to the company’s official filings and reports.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Abeona Therapeutics’s 8K filing here.

Abeona Therapeutics Company Profile

Abeona Therapeutics Inc, a clinical-stage biopharmaceutical company, focuses on developing and delivering gene therapy products for severe and life-threatening rare diseases. The company's lead programs are EB-101 (gene-corrected skin grafts) for recessive dystrophic epidermolysis bullosa (RDEB); ABO-102, which are AAV based gene therapies for Sanfilippo syndrome type A; and ABO-101, an adeno-associated virus (AAV) based gene therapies for Sanfilippo syndrome type B.