Ultragenyx Pharmaceutical(RARE)
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RARE, MREO Tank as Osteogenesis Study Fails to Meet Primary Endpoint
ZACKS· 2025-12-30 17:00
Core Insights - Shares of Ultragenyx Pharmaceutical (RARE) and Mereo BioPharma (MREO) fell significantly by 42.3% and 87.6% respectively after disappointing results from phase III studies evaluating setrusumab for osteogenesis imperfecta treatment [1][2] Study Results - The Orbit and Cosmic studies did not achieve statistical significance for their primary endpoints related to annualized clinical fracture rate compared to placebo or bisphosphonates [2][7] - Both studies showed statistically significant improvements in bone mineral density (BMD) as a secondary endpoint, with no changes in safety profiles [2][9] - In the Orbit study, participants had meaningful BMD improvements, but these did not lead to a reduction in fracture rates [9] - The Cosmic study indicated that while BMD improvements were observed in a younger patient population, the reduction in fracture rates compared to bisphosphonates was not statistically significant [10] Company Actions - Ultragenyx is reviewing its operations and will implement significant cost-reduction measures following the study results [3][7] - The company is conducting additional analyses on the data from both studies to explore other bone health and clinical endpoints beyond fractures [10] Stock Performance - Over the past six months, Ultragenyx shares have declined by 45.7%, while Mereo BioPharma shares have dropped by 89.7%, contrasting with a 25.9% increase in the industry [4]
CapsoVision, ACM Research And Other Big Stocks Moving Higher On Tuesday - ACM Research (NASDAQ:ACMR), AST SpaceMobile (NASDAQ:ASTS)
Benzinga· 2025-12-30 15:10
Group 1 - U.S. stocks experienced a decline, with the Dow Jones index falling more than 0.1% on Tuesday [1] - CapsoVision, Inc. shares rose sharply by 8.4% to $12.55 after submitting a 510(k) application to the FDA for its AI-assisted module for CapsoCam Plus [1] Group 2 - AXT, Inc. shares increased by 13.5% to $16.56 following the announcement of a public offering priced at $12.25 per share, totaling $87 million [2] - Ultragenyx Pharmaceutical Inc. shares gained 13.6% to $22.40 after a significant drop of 42% on Monday due to disappointing late-stage data [2] - Greenwich LifeSciences, Inc. shares rose 13.6% to $28.25, with an analyst maintaining a Buy rating and raising the price target from $39 to $50 [2] - SELLAS Life Sciences Group, Inc. shares increased by 12% to $3.7537 after providing an update on its Phase 3 REGAL trial for acute myeloid leukemia [2] - Fermi Inc. shares rose by 8.5% to $8.16 [2] - Redwire Corporation shares gained 8.3% to $7.61 [2] - Intuitive Machines, Inc. shares increased by 7% to $16.75 [2] - ACM Research, Inc. shares rose by 6.2% to $42.44, with a preliminary revenue outlook to be released on January 22, 2026 [2] - AST SpaceMobile, Inc. shares gained 6.1% to $75.87 [2] - Compass Diversified shares rose by 5.4% to $4.9350 [2]
Ultragenyx Bone Drug Stumbles In Phase 3, But Key Catalysts Remain
Benzinga· 2025-12-30 14:52
Core Viewpoint - Ultragenyx Pharmaceutical Inc. shares fell 42% following disappointing late-stage data for their rare bone disease program in collaboration with Mereo BioPharma Group plc [1] Group 1: Study Results - The Phase 3 Orbit and Cosmic studies for setrusumab (UX143) in Osteogenesis Imperfecta (OI) did not achieve statistical significance for the primary endpoints of reducing annualized clinical fracture rate compared to placebo or bisphosphonates [2] - Both studies met secondary endpoints, showing improvements in bone mineral density (BMD) against comparators, with no changes in the safety profile observed [2] Group 2: Analyst Reactions - Analysts from William Blair expressed disappointment and surprise at the results, especially given setrusumab's efficacy in the Phase 2 portion of the Orbit study and the increased enrollment of patients with severe disease subtypes in the Phase 3 study [3] - Analyst Sami Corwin is cautious about the future of setrusumab, noting several unknowns regarding the data, including potential effects in pediatric patients and the unexpectedly low annualized fracture rate in the placebo arm [4] Group 3: Market Impact and Future Outlook - Following the news, Ultragenyx is trading at a value reflective of its approved products, with William Blair maintaining an Outperform rating for the stock [4] - There is potential for upside in the next 12 months, particularly with the pivotal Angelman syndrome readout expected in Q3 2026 and the potential approval of two gene therapies eligible for priority review vouchers [5]
DigitalBridge downgraded, Commvault initiated: Wall Street's top analyst calls
Yahoo Finance· 2025-12-30 14:36
Upgrades - Argus upgraded BHP Group (BHP) to Buy from Hold with a price target of $68, citing firming prices for iron ore, copper, and coal as the global economy improves [2] Downgrades - Jefferies downgraded Mereo BioPharma (MREO) to Hold from Buy with a price target of 50 cents, down from $7, due to Setrusumab missing primary endpoints in trials, impacting Mereo's future strategy [3] - RBC Capital downgraded DigitalBridge (DBRG) to Sector Perform from Outperform with a price target of $16, down from $23, following SoftBank's acquisition announcement at $16 per share, totaling a $4 billion enterprise value [4] Initiations - Stephens initiated coverage of Commvault (CVLT) with an Overweight rating and a $162 price target, highlighting its leadership in data protection and transition to Software-as-a-Service [5] - Stephens initiated coverage of Rubrik (RBRK) with an Overweight rating and a $105 price target, noting its strong growth outlook in data protection and expected margin expansion [5] - Stephens initiated coverage of Varonis (VRNS) with an Equal Weight rating and a $40 price target, emphasizing its growth potential in data security as a Software-as-a-Service platform [5] - Freedom Capital initiated coverage of Ero Copper (ERO) with a Buy rating and a $32 price target, pointing out its high-grade, low-cost assets in Brazil [5] - H.C. Wainwright initiated coverage of Terra Innovatum (NKLR) with a Buy rating and a $25 price target, believing its use of off-the-shelf components will lower regulatory and technological barriers [5]
异动盘点1230 |石油股早盘上扬,昭衍新药跌超6%;铜矿板块集体下挫,Ultragenyx Pharmaceutical股价暴跌42.32%
贝塔投资智库· 2025-12-30 04:06
Group 1 - Zijin Mining (02899) rose nearly 3% after announcing the completion of the main construction and core equipment installation for the second phase of the Xizang Julong Copper Mine, marking a key step before production [1] - Asia Pacific Satellite (01045) increased over 5.4%, with a cumulative rise of nearly 30% over the past five trading days, as it operates multiple satellites under China Satcom [1] - Zhaoyan New Drug (06127) fell over 6% following an announcement that its actual controller plans to reduce holdings by up to 14.98 million shares, representing 20.0466% of his holdings and 1.99873% of the company's total share capital [1] - Zhongwei New Materials (02579) surged nearly 7% after signing a strategic cooperation framework agreement with Xinwanda for solid-state batteries [1] Group 2 - Dongyue Group (00189) rose nearly 5% as the long-term contract prices for refrigerants were confirmed, with R32 priced at 61,200 yuan/ton (+1,000 yuan) and R410A at 55,100 yuan/ton (+1,900 yuan) [2] - MicroPort Scientific Corporation (02252) increased over 1.2%, reporting that its core products' cumulative order volume exceeded 230 units [2] - Oil stocks saw gains, with CNOOC (00883) up 4.17%, PetroChina (00857) up 2.91%, and Sinopec (00386) up 1.31%, driven by a rise in international crude oil prices due to geopolitical tensions [2] - Baidu Group (09888) rose nearly 7% after announcing a partnership with Uber and Lyft to launch a robotaxi pilot project in the UK by 2026 [2] Group 3 - NIO (09866) rose over 2.4% after announcing that it successfully delivered over 40,000 units of its new ES8 model within 100 days of the official delivery start [3] - Damai Entertainment (01060) increased nearly 5%, with the total box office for the 2025 New Year’s season reaching 5.245 billion yuan as of December 28 [3] Group 4 - Copper mining stocks collectively declined, with Hudbay Minerals (HBM.US) down 4.01%, Taseko Mines (TGB.US) down 3.1%, and Ero Copper (ERO.US) down 1.64%, as international copper futures fell over 4% [5] - Some cryptocurrency-related stocks fell, with IREN Ltd (IREN.US) down 2.21% and Circle (CRCL.US) down 0.94% [5] - NIO (NIO.US) rose 4.71% in the US market, echoing its performance in Hong Kong [6] - The Nasdaq Golden Dragon Index fell nearly 1%, with major Chinese concept stocks declining, including Alibaba (BABA.US) down 2.46% and Xpeng Motors (XPEV.US) down 1.35% [6]
Why Ultragenyx Pharmaceuticals Stock Is Plummeting Today
The Motley Fool· 2025-12-29 20:14
Core Insights - Ultragenyx Pharmaceuticals announced disappointing Phase 3 study results for setrusumab, leading to a significant drop in stock price [1][4] - Analysts have reacted by slashing price targets for Ultragenyx stock, reflecting a negative outlook [7][9] Company Performance - Ultragenyx's shares are down 43.5%, currently priced at $19.25, with a market cap of $3.3 billion [2][5] - The Phase 3 studies, Orbit and Cosmic, failed to meet primary endpoints related to fracture rate reductions [4][6] Analyst Reactions - Cantor Fitzgerald cut its price target for Ultragenyx from $105 to $84 [9] - Barclays reduced its price target from $81 to $50 [9] - Citigroup lowered its price target from $103 to $50 [9] Market Context - The current trading range for Ultragenyx shares is between $18.41 and $20.49, with a 52-week range of $18.41 to $46.50 [5][6] - The gross margin for the company stands at 79.09% [6] Future Considerations - Investors are advised to monitor the company’s upcoming data from the Phase 3 study of GTX-102 for Angelman syndrome before making investment decisions [8]
Why Ultragenyx Pharmaceutical Shares Are Trading Lower By Around 42%? Here Are Other Stocks Moving In Monday's Mid-Day Session - Autolus Therapeutics (NASDAQ:AUTL), Brand Engagement Network (NASDAQ:BN
Benzinga· 2025-12-29 17:33
Company Performance - Ultragenyx Pharmaceutical Inc. shares fell 42% to $19.84 following the announcement of Phase 3 study results for setrusumab (UX143) in Osteogenesis Imperfecta (OI) [1] - Mereo BioPharma Group plc shares dropped 90% to $0.23 after its Phase 3 studies for setrusumab did not achieve statistical significance against primary endpoints [5] Market Movements - Republic Power Group Ltd surged 163% to $0.69 [5] - Brand Engagement Network Inc jumped 84.3% to $2.21 after entering a Vendor Services Project Agreement [5] - DigitalBridge Group Inc rose 9.9% to $15.30 following the announcement of its acquisition by SoftBank Group for approximately $4.0 billion [5] Precious Metals Sector - Hycroft Mining Holding Corporation was down 14% to $21.61 as precious metal stocks traded lower due to a retreat in commodity prices [6] - Silver prices pulled back after reaching an all-time high, impacting related stocks [6]
美股异动 | 治疗遗传性骨病在研药物临床试验失败 Ultragenyx Pharmaceutical(RARE.US)盘前暴跌超42%
Zhi Tong Cai Jing· 2025-12-29 14:36
Core Viewpoint - Ultragenyx Pharmaceutical's stock plummeted over 42% in pre-market trading following the announcement that its investigational drug for a specific genetic bone disease failed to meet primary efficacy endpoints in late-stage clinical trials [1] Company Summary - The stock price of Ultragenyx Pharmaceutical (RARE.US) fell to $19.69 as of the latest report [1] - The failure of the drug in clinical trials represents a significant setback for the company, impacting investor confidence and market valuation [1]
治疗遗传性骨病在研药物临床试验失败 Ultragenyx Pharmaceutical(RARE.US)盘前暴跌超42%
Zhi Tong Cai Jing· 2025-12-29 14:34
Core Viewpoint - Ultragenyx Pharmaceutical's stock price plummeted over 42% to $19.69 following the announcement that its investigational drug for a specific genetic bone disease did not meet its primary efficacy endpoint in late-stage clinical trials [1] Group 1 - The stock price of Ultragenyx Pharmaceutical (RARE.US) experienced a significant decline, dropping more than 42% [1] - As of the report, the stock was trading at $19.69 [1] - The decline was triggered by the failure of a key investigational drug in late-stage clinical trials [1]
Ultragenyx治疗遗传性骨病药物后期临床试验失败
Xin Lang Cai Jing· 2025-12-29 14:18
Core Viewpoint - Ultragenyx Pharmaceutical announced that its investigational drug for a specific genetic bone disease did not meet the primary efficacy endpoint in late-stage clinical trials [1] Group 1 - The investigational drug is aimed at treating a specific genetic bone disease [1] - The announcement was made on a Monday [1] - The failure to meet the primary efficacy endpoint occurred during late-stage clinical trials [1]