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On Tuesday, Stifel analysts maintained a positive stance on Regenxbio Inc . (NASDAQ:RGNX) shares, reiterating a Buy rating and a price target of $40.00. Trading at $8.54, the stock appears undervalued according to InvestingPro analysis, with analyst targets ranging from $12 to $52. The firm’s endorsement comes as Regenxbio transitions from a gene therapy (GTx) development phase towards the commercialization of its products. The company is currently awaiting the FDA’s imminent acceptance of its first accelerated Biologics License Application (BLA) for RGX-121, a treatment for Mucopolysaccharidosis Type II (MPS-II).[Get detailed insights and 8 additional ProTips for RGNX with InvestingPro]
Regenxbio has made significant progress in its Phase 3 enrollment for RGX-202, with over half of the required participants already enrolled. This milestone has been driven by strong demand, supported by consistent biomarker and functional benefit data. The company has also initiated commercial readiness activities for RGX-202, which suggests a high likelihood of another positive functional data readout expected within this quarter.
The analysts noted that FDA interactions regarding Regenxbio’s programs have been consistent and are potentially increasing in a constructive manner. In the field of retinal disease, Regenxbio’s partner AbbVie (NYSE:ABBV) continues to enroll patients for the Phase 3 trials of ABBV-RGX-314 for wet Age-Related Macular Degeneration (wAMD), with completion targeted for 2025 and results anticipated in 2026. Additionally, preparations are underway for the pivotal initiation of RGX-314 in subcutaneous form for diabetic retinopathy.
Stifel’s analysis highlights that with Regenxbio’s stock trading below its cash balance of $272 million plus more than $350 million in potential development fees and Priority Review Voucher (PRV) value, the shares offer a significant opportunity for value realization as the company’s pipeline continues to materialize. Financial metrics from InvestingPro support this view, showing a healthy current ratio of 2.93 and more cash than debt on the balance sheet, though the company is currently burning through cash with an EBITDA of -$141.37 million in the last twelve months. With a market cap of $421.48 million and projected sales growth ahead, investors might find value in this developing story.[Access the comprehensive Pro Research Report and real-time financial metrics for RGNX on InvestingPro]
In other recent news, Regenxbio Inc. reported its first-quarter 2025 earnings, which showed a significant miss on both earnings per share (EPS) and revenue forecasts. The company posted an EPS of $0.12, falling short of the projected $0.48, and revenue came in at $89 million compared to the anticipated $107.85 million. Despite these results, Regenxbio’s stock rose in aftermarket trading, reflecting investor optimism about the company’s strategic partnerships and promising gene therapy pipeline. Additionally, the U.S. Food and Drug Administration (FDA) has accepted Regenxbio’s Biologics License Application (BLA) for RGX-121, a potential gene therapy for Mucopolysaccharidosis II (MPS II), also known as Hunter syndrome, with a target action date set for November 9, 2025. The FDA’s priority review status for RGX-121 has garnered positive investor sentiment, indicating confidence in the therapy’s market potential. Regenxbio’s strategic partnership with Nippon Shinyaku positions the company for commercialization of RGX-121 in the U.S. upon FDA approval. The company’s cash and equivalents increased to $272 million, partly due to a $110 million upfront payment from this partnership, providing a solid foundation for future growth. These developments mark significant steps for Regenxbio as it seeks to bring innovative treatments to market.
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