On Monday, H.C. Wainwright reaffirmed its Buy rating and $15.00 price target for NASDAQ:ABEO, Abeona Therapeutics (NASDAQ:ABEO). The firm's confidence is anchored in the recent development that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for Abeona's lead candidate, prademagene zamikeracel (pz-cel, formerly known as EB-101). The FDA has scheduled an approval decision date, known as a Prescription Drug User Fee Act (PDUFA) date, for April 29, 2025.
The acceptance of the BLA by the FDA marks a significant milestone for Abeona Therapeutics, as it brings the company one step closer to potentially bringing its therapy to market. The therapy is designed to address the needs of patients with recessive dystrophic epidermolysis bullosa (RDEB), a rare and severe skin disorder. The firm's analysis suggests that the product could be a leading treatment option for the most challenging RDEB cases upon approval.
H.C. Wainwright's statement highlights the potential for prademagene zamikeracel to be used not only as a standalone therapy but also in combination with other approved treatments such as VYJUVEK (beremagene geperpavec) for certain patients. The firm's outlook is further bolstered by the comparison of pz-cel's efficacy and durability against the existing treatment Filsuvez (birch triterpenes topical gel), which carries a high list price of approximately $500,000.
The analyst from H.C. Wainwright expressed optimism about Abeona Therapeutics' competitive edge in the market, especially given the perceived limitations of Filsuvez. With the FDA's review process underway, the company awaits the decision that could potentially allow for the commercialization of its lead candidate. The reiterated Buy rating and price target reflect the firm's continued endorsement of Abeona's stock as an investment.
In other recent news, Abeona Therapeutics has shared its Q3 2024 results and updates on its lead gene therapy product, Pradimogene zamykerathal (PZ cell).
The biopharmaceutical company reported a net loss of $30.3 million for the quarter, largely due to warrant liability remeasurement. Despite this, Abeona's cash reserves stand at a robust $110 million, projected to fund operations until 2026. The FDA has accepted the resubmission of the Biologics License Application for PZ cell, setting a PDUFA date for April 2025.
Abeona is making strides in its commercial preparations, with five treatment centers qualified and pricing strategies for the one-time gene therapy under exploration. In addition to these developments, the company has been granted two new patents, bolstering its intellectual property portfolio and protection until 2037 and 2040.
InvestingPro Insights
To complement the positive outlook from H.C. Wainwright on Abeona Therapeutics (NASDAQ:ABEO), recent data from InvestingPro provides additional context for investors. Despite the company's promising lead candidate and potential market opportunity, InvestingPro Tips highlight that Abeona is "quickly burning through cash" and "not profitable over the last twelve months." This aligns with the company's current stage of development, as it awaits FDA approval for its therapy.
The company's financial position shows a market capitalization of $260.69 million, reflecting investor expectations for future growth. Interestingly, Abeona's stock has seen a significant 47.29% price increase over the past six months, indicating growing market optimism possibly tied to the FDA's acceptance of the BLA for prademagene zamikeracel.
For investors seeking a more comprehensive analysis, InvestingPro offers 8 additional tips for Abeona Therapeutics, providing a deeper understanding of the company's financial health and market position as it approaches this critical juncture in its product development timeline.
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