Money Chance: ABEO ' s New Drug Application of Recessive dystrophic epidermolysis bullosa to be Decided by FDA soon

Summary:
This week, FDA would give a NDA (New Drug Application) result, which means a large potential market movements for investors:
Pz-cel (prademagene zamikeracel) EB-101 (COL7A1) for Recessive dystrophic epidermolysis bullosa,from ABEO,PDUFA date is April 29 2025.

Why should focus PDUFA Date:
The PDUFA (Prescription Drug User Fee Act) is a critical regulatory milestone in the drug development process. It refers to the date by which the FDA (Food and Drug Administration) is expected to make a decision on a new drug application. As the pharmaceutical industry is highly regulated, the FDA plays a crucial role in approving or rejecting drugs that can be marketed in the United States.
When a PDUFA date is approaching, it creates an investment opportunity for traders and investors to capitalize on the potential market movements related to the FDA's decision on drug approvals or rejections. Typically, a positive outcome can lead to an increase in the stock price of the pharmaceutical company, while a negative outcome can lead to a decline in the stock price.

About Recessive dystrophic epidermolysis bullosa
Recessive dystrophic epidermolysis bullosa (RDEB) is a severe form of EB characterized by a mutation in the COL7A1 gene, which leads to defective type VII collagen synthesis and anchoring fibril assembly. This results in poor epidermal-dermal adherence, causing skin fragility and blistering. RDEB is one of the most severe forms of EB, with symptoms including chronic wounds, skin cancer, and a high risk of squamous cell carcinoma. Current treatments are largely supportive, focusing on wound care and pain management. However, there is ongoing research into gene therapy, cell therapy, and protein-based therapy, which offer promising avenues for future treatment and potential cure.

About Pz-cel (prademagene zamikeracel) EB-101 (COL7A1)
Abeona Therapeutics has recently received a significant milestone in its quest to bring pz-cel (prademagene zamikeracel) to market. The U.S. FDA has accepted and granted Priority Review for the Biologics License Application (BLA) for pz-cel, an investigational gene therapy designed to treat recessive dystrophic epidermolysis bullosa (RDEB), a rare and severe skin disorder. This designation underscores the high unmet need in RDEB and the potential for pz-cel to provide meaningful benefits to patients. The FDA has set a target action date of May 25, 2024, under the Prescription Drug User Fee Act (PDUFA). Notably, the FDA does not plan to convene an Advisory Committee meeting to discuss the pz-cel application. This development is a crucial step forward in Abeona's goal to bring this life-altering therapy to patients as soon as possible.

About Abeona Therapeutics(ABEO)
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