Bullish indicating open at $55-$60, IPO prices at $37
On Friday, H.C. Wainwright analysts reiterated a Buy rating and maintained a $34 price target on Regenxbio Inc . (NASDAQ:RGNX), a $419 million market cap biotech company, following the release of new positive interim data from the company’s AFFINITY DUCHENNE trial. According to InvestingPro data, analysts broadly maintain a bullish stance with targets ranging from $13 to $52, suggesting significant upside potential. The trial, focusing on RGX-202 for Duchenne muscular dystrophy, showed consistent benefits in participants at 9 and 12 months post-treatment.
The interim results highlighted improvements in various functional measures, including the North Star Ambulatory Assessment, attributing these to microdystrophin expression after RGX-202 treatment. The data suggests that the treatment is delaying disease progression in patients who would typically experience functional decline. While the company maintains a strong balance sheet with more cash than debt and a healthy current ratio of 2.93x, InvestingPro analysis indicates rapid cash burn requires monitoring.
Regenxbio management noted that over half of the ambulatory patients aged 1 and above have been enrolled in the pivotal portion of the AFFINITY DUCHENNE trial. This segment of the trial is expected to report topline data in the first half of 2026, which could lead to a Biologics License Application submission under the accelerated approval pathway by mid-2026.
The positive interim data has reinforced the analysts’ confidence in the potential of RGX-202, leading to the reaffirmation of the Buy rating and the $34 price target.
In other recent news, REGENXBIO Inc. reported encouraging interim data from its Phase I/II AFFINITY DUCHENNE trial, showcasing positive functional, safety, and biomarker outcomes for its gene therapy, RGX-202. Participants treated with Dose Level 2 demonstrated improved performance on functional measures and exceeded external natural history controls at 9 and 12 months post-treatment. Stifel analysts, recognizing the significance of these results, reiterated their Buy rating on the company’s stock with a $40.00 price target. In addition, REGENXBIO has secured a financial boost through a royalty bond agreement with Healthcare Royalty, receiving $150 million upfront with the potential for up to $250 million. This strategic move aims to extend the company’s cash runway into early 2027, supporting late-stage activities such as the potential FDA approval of RGX-121 for MPS II and the submission of a Biologics License Application for RGX-202. The company is also progressing in its Phase 3 enrollment for RGX-202, with over half of the required participants already enrolled. Stifel analysts noted that REGENXBIO’s financial position is further strengthened by expected non-dilutive funding sources, potentially extending resources well into 2028.
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