CLEVELAND - Abeona Therapeutics Inc. (NASDAQ:ABEO), a clinical-stage biopharmaceutical company, has received a product-specific procedure code from the Centers for Medicare and Medicaid Services (CMS) for its gene therapy candidate pz-cel. The code, designated for prademagene zamikeracel (pz-cel), is expected to streamline hospital billing and reimbursement processes upon the therapy's potential approval.
The new ICD-10-PCS code, which is set to become effective on October 1, 2024, will allow for precise documentation and analysis of inpatient procedures involving pz-cel, Abeona's investigational treatment for recessive dystrophic epidermolysis bullosa (RDEB). This rare genetic disorder affects the skin's ability to repair and regenerate, often resulting in severe blistering and wounds.
Furthermore, CMS has assigned pz-cel to a high reimbursement category under the Inpatient Prospective Payment System (IPPS) for fiscal year 2025. The Medicare Severity Diagnosis Related Group (MS-DRG) 018 is among the highest for inpatient hospital reimbursement levels for cell and gene therapies. This classification is also slated to take effect on October 1, 2024.
Madhav Vasanthavada, Chief Commercial Officer at Abeona, expressed satisfaction with CMS's recognition of pz-cel as a breakthrough gene therapy technology. He noted the decision by CMS as a significant step towards ensuring access and reimbursement for RDEB patients, complementing positive feedback from commercial payers.
Pz-cel is currently in development, designed to deliver a functional collagen-producing gene into a patient's skin cells using a retroviral vector. The Phase 3 VIITAL™ study has evaluated the therapy's efficacy, safety, and tolerability. Pz-cel has received multiple designations from the U.S. Food and Drug Administration (FDA), including Regenerative Medicine Advanced Therapy and Breakthrough Therapy.
Abeona produces pz-cel at its gene and cell therapy manufacturing facility in Cleveland, Ohio, which is capable of supporting commercial production upon FDA approval.
This news is based on a press release statement and is part of ongoing developments in the field of gene therapy and biopharmaceuticals. The granting of the procedure code and DRG assignment by CMS could facilitate the future billing and reimbursement for pz-cel, pending its potential approval by the FDA.
In other recent news, Abeona Therapeutics has made substantial progress towards the resubmission of its Biologics License Application for prademagene zamikeracel, a gene therapy for recessive dystrophic epidermolysis bullosa.
The company has completed most of the required data generation and expects to resubmit in the latter half of 2024. Financial services companies H.C. Wainwright and Stifel have both reaffirmed their positive outlook on Abeona, citing the potential of the company's gene therapy advancements.
In addition, Abeona has partnered with Beacon Therapeutics to explore potential gene therapies for eye diseases, focusing on Abeona's patented AAV204 capsid. The company has also reported a net income of $7.4 million for Q2 of 2024 and closed a $75 million securities offering in May 2024.
These are the recent developments in the company's operations. However, it's important to note that these facts do not serve as a comprehensive view of Abeona Therapeutics.
InvestingPro Insights
As Abeona Therapeutics Inc. (NASDAQ:ABEO) advances its gene therapy candidate pz-cel towards potential approval, the company's financial health remains a key area of interest for investors. With a market capitalization of approximately $202.77 million, Abeona is a moderate-sized player in the biopharmaceutical space. The company's financial metrics reflect its status as a clinical-stage entity, with a significant revenue growth of 227.72% in the last twelve months as of Q1 2024, indicating a growing interest in its pipeline.
However, the financial situation at Abeona is complex, with a reported gross profit margin of -810.34% in the same period. This underscores the company's current challenges in generating profit from its operations, as it continues to invest heavily in research and development. Additionally, Abeona's P/E ratio stands at -1.6, with an adjusted P/E ratio of -2.62, highlighting that the company is not currently generating earnings—a common scenario for clinical-stage biopharmaceutical companies.
InvestingPro Tips for Abeona reveal a mixed picture: while the company holds more cash than debt, suggesting a degree of financial stability, it is also quickly burning through cash, which is a concern for its long-term sustainability. Moreover, Abeona's stock price has been volatile, reflecting the high-risk nature of investing in clinical-stage biopharmaceuticals. On a positive note, Abeona has demonstrated a strong return over the last three months, with a 15.12% price total return, which may interest investors looking for short-term gains.
For those considering an investment in Abeona, it is worth noting that the company does not pay a dividend, which is typical for companies that are not yet profitable. With analysts not anticipating profitability this year, potential investors should weigh the prospects of the company's gene therapy candidate against the backdrop of its financial metrics. For additional insights, there are 10 more InvestingPro Tips available for Abeona, which can be found at https://www.investing.com/pro/ABEO, offering a deeper dive into the company's financial health and investment potential.
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