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Investing.com - H.C. Wainwright has reiterated its Buy rating and $20.00 price target on Abeona Therapeutics (NASDAQ:ABEO), currently trading at $5.74 with a market cap of $294 million, following the FDA’s Complete Response Letter (CRL) for the company’s gene therapy treatment. According to InvestingPro, analysts maintain a Strong Buy consensus with price targets ranging from $11 to $27.50.
The FDA requested additional information related to chemistry, manufacturing and controls (CMC) and noted observations from recent manufacturing facility inspections for UX111, a gene therapy treatment for Sanfilippo syndrome type A (MPS IIIA). InvestingPro data shows the company maintains a strong liquidity position with a current ratio of 4.9x, though it’s experiencing rapid cash burn.
The regulatory agency acknowledged the robustness of the neurodevelopmental outcome data provided to date, with biomarker data offering additional supportive evidence, according to H.C. Wainwright.
The CRL did not identify any issues with the clinical data package or clinical inspections, but requested updated clinical data from current patients be included in the resubmission, which could face up to a six-month review period.
H.C. Wainwright maintains that UX111 remains "eminently approvable" and notes that while Abeona would be entitled to royalties on net sales if approved, its valuation assessment does not factor in such royalties, thus the CRL does not impact its investment thesis.
In other recent news, Abeona Therapeutics announced the sale of its Rare Pediatric Disease Priority Review Voucher for $155 million, bolstering its financial position with approximately $225 million in cash and investments. This transaction provides Abeona with substantial financial flexibility, ensuring over two years of operating capital. Abeona’s cell-based gene therapy, ZEVASKYN, received FDA approval, with its first patient treatment expected in the third quarter of 2025. Analysts at Oppenheimer have assumed coverage of Abeona Therapeutics with an Outperform rating, highlighting the strong momentum following ZEVASKYN’s approval. Meanwhile, Stifel adjusted its price target for Abeona to $20, maintaining a Buy rating, citing anticipated revenue impacts in the latter half of 2025. Abeona’s financial position was further strengthened by the PRV sale, equating to over $2 per share on a fully-diluted basis. Additionally, Beacon Therapeutics licensed Abeona’s AAV204 capsid for potential retinal gene therapies, marking another strategic development for the company. Bio-Techne (NASDAQ:TECH)’s Simple Western technology supported the FDA approval of ZEVASKYN, emphasizing its role in quality control testing. These developments reflect Abeona’s strategic advancements in gene therapy and its strengthened financial outlook.
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