Core Viewpoint - Ultragenyx Pharmaceutical Inc. will host a conference call on February 12, 2026, to discuss its financial results and corporate updates for the year ending December 31, 2025 [1]. Group 1: Company Overview - Ultragenyx is a biopharmaceutical company focused on developing and commercializing novel products for serious rare and ultra-rare genetic diseases [3]. - The company has established a diverse portfolio of approved therapies and product candidates aimed at addressing diseases with high unmet medical needs [3]. - Ultragenyx's management team has extensive experience in the development and commercialization of therapeutics for rare diseases [4]. Group 2: Strategic Approach - The company's strategy emphasizes time- and cost-efficient drug development to deliver safe and effective therapies to patients urgently [4].

Faruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses In Ultragenyx To Contact Him Directly To Discuss Their Options If you purchased or acquired securities in Ultragenyx between August 3, 2023 and December 26, 2025 and would like to discuss your legal rights, call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310). [You may also click here for additional information] NEW YORK, Feb. 05, 2026 (GLOBE NEWSWIRE) -- ...

NEW YORK--(BUSINESS WIRE)--Rosen Law Firm, a global investor rights law firm, announces a class action lawsuit on behalf of purchasers of common stock of Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) between August 3, 2023 and December 26, 2025. Ultragenyx describes itself as a "biopharmaceutical company focused on rare and ultrarare genetic disorders.†For more information, submit a form, email attorney Phillip Kim, or give us a call at 866-767-3653. The Allegations: Rosen Law Firm is Investig. ...

NEW YORK, Feb. 05, 2026 (GLOBE NEWSWIRE) -- Gainey McKenna & Egleston announces that a securities class action lawsuit has been filed in the United States District Court for the Northern District of California on behalf of all persons or entities who purchased or otherwise acquired Ultragenyx Pharmaceutical Inc. (“Ultragenyx” or the “Company”) (NASDAQ: RARE) securities between August 3, 2023 and December 26, 2025, inclusive (the “Class Period”). The Complaint alleges that Defendants provided misleading stat ...

ATLANTA, Feb. 05, 2026 (GLOBE NEWSWIRE) -- A shareholder class action lawsuit has been filed against Ultragenyx Pharmaceutical Inc. (“Ultragenyx” or the “Company”) (NASDAQ: RARE). The lawsuit alleges that Defendants issued false and misleading statements and/or failed to disclose material adverse facts regarding Ultragenyx’s expected results for its Phase III Orbit and Cosmic Studies, including setrusumab’s potential and the risks inherent in the study protocols put forth. If you purchased Ultragenyx shares ...

Core Viewpoint - The Ultragenyx class action lawsuit alleges that the company and its executives made misleading statements regarding the efficacy of setrusumab in treating Osteogenesis Imperfecta, leading to significant stock price declines when the truth was revealed [4][5][6]. Company Overview - Ultragenyx Pharmaceutical Inc. is a biopharmaceutical company focused on developing treatments for rare and ultra-rare genetic diseases [3]. Allegations of the Lawsuit - The lawsuit claims that Ultragenyx misrepresented the reliability of information regarding setrusumab's effects and downplayed the risks associated with the Phase III Orbit study, which ultimately failed to show statistically significant results [4]. - On July 9, 2025, Ultragenyx disclosed that the Phase III Orbit study did not achieve statistical significance, resulting in a stock price drop of over 25% [5]. - On December 29, 2025, the company announced that both the Phase III Orbit and Cosmic studies failed to meet primary endpoints, causing a further stock price decline of more than 42% [6]. Legal Process - The Private Securities Litigation Reform Act of 1995 allows investors who purchased Ultragenyx stock during the class period to seek appointment as lead plaintiff in the lawsuit, representing the interests of all class members [7]. Law Firm Background - Robbins Geller Rudman & Dowd LLP is a leading law firm in securities class action recoveries, having recovered over $916 million for investors in 2025 alone, and a total of $8.4 billion over the past five years [8].

Core Viewpoint - The Ultragenyx class action lawsuit alleges that the company and its executives made misleading statements regarding the efficacy of their drug setrusumab, leading to significant stock price declines when the truth was revealed [4][5][6]. Company Overview - Ultragenyx is a biopharmaceutical company focused on developing treatments for rare and ultra-rare genetic diseases [3]. Allegations of the Lawsuit - The lawsuit claims that Ultragenyx misrepresented the reliability of information regarding setrusumab's effects on Osteogenesis Imperfecta (OI) patients and downplayed the risks associated with the Phase III Orbit study [4]. - It is alleged that Ultragenyx's optimism regarding the Phase III Orbit study was unfounded, as the results were based on Phase II data without a placebo control group, which could have led to misleading conclusions about the drug's effectiveness [4]. Stock Price Impact - Following the announcement on July 9, 2025, that the Phase III Orbit study did not achieve statistical significance, Ultragenyx's stock price fell by over 25% [5]. - On December 29, 2025, after revealing that both the Phase III Orbit and Cosmic studies failed to meet primary endpoints, the stock price dropped by more than 42% [6]. Lead Plaintiff Process - The Private Securities Litigation Reform Act of 1995 allows investors who purchased Ultragenyx common stock during the Class Period to seek appointment as lead plaintiff in the class action lawsuit [7]. - The lead plaintiff represents the interests of all class members and can select a law firm to litigate the case [7]. Law Firm Background - Robbins Geller Rudman & Dowd LLP is recognized for recovering over $916 million for investors in 2025 and has a strong track record in securities class action recoveries, totaling $8.4 billion over the past five years [8].

Core Viewpoint - Robbins LLP has initiated a class action lawsuit on behalf of investors who purchased Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) common stock between August 3, 2023, and December 26, 2025, alleging that the company misled investors regarding the Phase III Orbit and Cosmic Studies for setrusumab [1][2]. Allegations - The lawsuit claims that during the class period, Ultragenyx provided investors with overly positive information about the expected results of the Phase III Orbit and Cosmic Studies, which tested setrusumab in patients with Osteogenesis Imperfecta (OI) [2]. - Defendants allegedly expressed confidence in setrusumab's ability to reduce the annualized fracture rate in OI patients and in the study designs to demonstrate this ability, while concealing material adverse facts about the drug's true potential and the risks associated with the study protocols [3]. Study Results and Impact - On December 29, 2025, Ultragenyx announced that the Phase III Orbit and Cosmic Studies did not achieve statistical significance in reducing the annualized clinical fracture rate compared to placebo or bisphosphonates [4]. - Following this announcement, Ultragenyx's stock price plummeted from $34.19 per share on December 26, 2025, to $19.72 per share on December 29, 2025, marking a decline of approximately 42.32% in just one day [4]. Next Steps for Shareholders - Shareholders interested in participating in the class action against Ultragenyx are encouraged to contact Robbins LLP, with the option to serve as lead plaintiff or remain an absent class member [5].

NEW YORK, Feb. 03, 2026 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Ultragenyx Pharmaceutical Inc. (“Ultragenyx” or the “Company”) (NASDAQ: RARE). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. The investigation concerns whether Ultragenyx and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.  [Click here for information about joining the class acti ...

Core Insights - Ultragenyx Pharmaceutical (RARE) has resubmitted its biologics license application (BLA) to the FDA for accelerated approval of its gene therapy candidate UX111, aimed at treating Sanfilippo syndrome type A (MPS IIIA) [1][8] - The company’s shares have decreased by 44.6% over the past year, contrasting with a 15.2% increase in the industry [2] BLA Resubmission Details - The FDA issued a Complete Response Letter (CRL) in July 2025, requesting additional information regarding chemistry, manufacturing, and controls (CMC) elements, which were facility- and process-related issues not tied to product quality [3][10] - The resubmitted BLA addresses all CMC observations from the CRL and includes long-term data supporting neurological benefits, along with biomarker data in line with FDA agreements [4][11] Regulatory Timeline - A target action date from the FDA is expected within a month, with a review period of up to six months anticipated, aiming for a decision in the third quarter of 2026 [5][8] Clinical Data and Efficacy - The original BLA submission was supported by data from the phase I/II/III Transpher A study, which showed that UX111 treatment led to a significant reduction in heparan sulfate (HS) levels in cerebrospinal fluid (CSF) and improved long-term cognitive development [9][11] - The updated clinical data in the resubmission includes an additional year of patient follow-up, demonstrating durable treatment benefits and increasing separation from untreated outcomes [11] Disease Context - Sanfilippo syndrome type A is a rare, fatal lysosomal storage disorder affecting the central nervous system, with approximately 3,000 to 5,000 patients in commercially accessible areas and a median life expectancy of 15 years [14]