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Investing.com - Morgan Stanley (NYSE:MS) has reiterated an Overweight rating and $65.00 price target on Ultragenyx Pharma (NASDAQ:RARE), currently trading at $41.44, as the company’s Phase 3 Orbit study for setrusumab progresses toward final analysis expected by year-end 2025. According to InvestingPro data, analysts maintain a Strong Buy consensus with targets ranging from $39 to $136.
The Data Monitoring Committee confirmed setrusumab’s acceptable safety profile and recommended continuation of the study to final analysis. No p-values were provided with this interim analysis, and the second Phase 3 study, Cosmic, was not analyzed at this stage.
Patients will continue dosing across both trials, with final analysis planned after patients complete at least 18 months of therapy. The predefined threshold for statistical significance is set at p
Morgan Stanley noted that setrusumab achieved a 67% fracture reduction (p=0.04) at 6 months in the Phase 2 trial, which was maintained at 14 months with improving statistical significance (p=0.0014). This improvement occurs because fracture rates diverge further with longer follow-up.
The investment firm recognizes the unmet need in osteogenesis imperfecta, as bisphosphonates are used off-label, and continues to see scientific rationale for setrusumab’s efficacy. Morgan Stanley currently models a 60% probability of success with risk-adjusted U.S. peak sales of approximately $430 million in 2035. For deeper insights into Ultragenyx’s valuation and growth prospects, access the comprehensive Pro Research Report, available exclusively on InvestingPro, which covers over 1,400 US stocks with expert analysis and actionable intelligence.
In other recent news, Ultragenyx Pharmaceutical (TADAWUL:2070) announced that its Phase 3 Orbit study for setrusumab, a treatment for osteogenesis imperfecta, will proceed to a final analysis phase after failing to meet the predetermined interim analysis thresholds. This decision follows the study’s inability to achieve the statistical significance required at the second interim analysis, prompting the continuation of the trial with results expected by the end of 2025. Despite the setback, Wells Fargo (NYSE:WFC) maintained an Overweight rating, while Canaccord Genuity and BofA Securities held their Buy ratings, with price targets of $136 and $80, respectively. The Data Monitoring Committee confirmed that setrusumab has an acceptable safety profile, allowing the study to continue. Analysts from BofA Securities suggest that the extended study duration might increase the likelihood of success due to more fracture events accruing. Goldman Sachs also maintained a Buy rating with a price target of $82, projecting peak global sales of $1.6 billion by 2033. Mereo BioPharma, in collaboration with Ultragenyx, confirmed the trial’s progression, with the final analysis applying a lower statistical threshold. This development comes amid investor concerns and ongoing debates about the trial’s outcomes and future implications.
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