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Investing.com - Ultragenyx Pharma (NASDAQ:RARE) shares dropped approximately 27% in after-hours trading after the company announced its Phase 3 Orbit study of setrusumab in osteogenesis imperfecta (OI) will proceed to final analysis. The company, which has seen its stock trade between $29.59 and $60.37 over the past 52 weeks, currently appears undervalued according to InvestingPro analysis.
The announcement indicates the drug candidate did not achieve the statistical threshold (p
The final analysis, expected around year-end 2025, will apply a lower statistical bar of p
Ultragenyx management expressed confidence in the study’s ultimate success, citing previous Phase 2 results that demonstrated a 67% reduction in annualized fracture rate with a p-value of 0.0014 at 14 months. The final analysis of the Phase 3 Cosmic study in children ages two to five is also expected around year-end.
Goldman Sachs projects peak global sales of $1.6 billion for Ultragenyx by 2033, based on estimated 14% U.S. market penetration and 12% European market penetration, potentially strengthened by the company’s existing commercial infrastructure with Crysvita in X-linked hypophosphatemia. The company’s strong liquidity position, with a current ratio of 2.4 and revenue growth of 33.46% in the last twelve months, supports these ambitious projections. For deeper insights into Ultragenyx’s financial health and growth prospects, access the comprehensive Pro Research Report available on InvestingPro.
In other recent news, Ultragenyx Pharmaceutical (TADAWUL:2070) Inc. reported significant developments impacting its financial and operational landscape. The company achieved a 29% revenue increase in 2024, reaching $560 million, with a projected growth of 14%-20% for 2025. This growth trajectory is supported by the company’s four commercialized products. Additionally, Ultragenyx received Breakthrough Therapy Designation from the FDA for its Angelman syndrome drug, GTX-102, based on promising Phase 1/2 study results. This designation is expected to expedite the drug’s development and review process.
In the realm of clinical trials, Ultragenyx’s Phase 3 Orbit study for UX143 in osteogenesis imperfecta patients will continue to final analysis, as interim results did not meet the threshold for early stoppage. Despite this, Citi has reiterated its Buy rating on Ultragenyx, maintaining a price target of $110, and expressed confidence in the trial’s eventual success. William Blair also set an Outperform rating on Ultragenyx with a $65 target, citing the company’s strong revenue performance and growth potential. These recent developments highlight Ultragenyx’s ongoing efforts to advance treatments for rare genetic diseases.
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