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<title>Ultragenyx</title>
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<title>Ultragenyx Announces U.S. FDA Acceptance of BLA Resubmission for UX111 AAV Gene Therapy to Treat Sanfilippo Syndrome Type A (MPS IIIA)</title>
<link>https://6ix.com/company/ultragenyx/news/ultragenyx-announces-us-fda-acceptance-of-bla-resubmission-for-ux111-aav-gene-therapy-to-treat-sanfilippo-syndrome-type-a-mps-iiia-63</link>
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<pubDate>Thu, 02 Apr 2026 04:00:00 GMT</pubDate>
<description>If approved, UX111 will be the first approved therapy for the treatment of Sanfilippo syndrome Type A, a rare disease affecting young children that leads to</description>
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<title>Ultragenyx Announces FDA Clearance of Investigational New Drug (IND) Application for UX016, a Sialic Acid Prodrug for the Treatment of GNE Myopathy</title>
<link>https://6ix.com/company/ultragenyx/news/ultragenyx-announces-fda-clearance-of-investigational-new-drug-ind-application-for-ux016-a-sialic-acid-prodrug-for-the-treatment-of-gne-myopathy</link>
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<pubDate>Mon, 30 Mar 2026 04:00:00 GMT</pubDate>
<description>Program to be externally funded by a venture philanthropy agreement through clinical proof-of-concept, including the Phase 1/2 study planned to begin in the</description>
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<title>Mereo BioPharma Reports Full Year 2025 Financial Results and Provides Corporate Highlights</title>
<link>https://6ix.com/company/ultragenyx/news/mereo-biopharma-reports-full-year-2025-financial-results-and-provides-corporate-highlights</link>
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<pubDate>Thu, 19 Mar 2026 12:30:00 GMT</pubDate>
<description>Additional data analyses from Orbit and Cosmic Phase 3 studies of setrusumab (UX143) in osteogenesis imperfecta ongoing Cash of $41.0 million as of December 31, 2025, expected to provide runway into mid-2027 LONDON, March 19, 2026 (GLOBE NEWSWIRE) -- Mereo BioPharma Group plc (NASDAQ: MREO) (“Mereo” or the “Company”), a clinical-stage biopharmaceutical company focused on rare diseases, today announced financial results for the full year ended December 31, 2025, and provided an update on recent c</description>
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<title>Ultragenyx Announces Positive 36-Week Data from Phase 3 Study of DTX301 AAV8 Gene Therapy for the Treatment of Ornithine Transcarbamylase (OTC) Deficiency</title>
<link>https://6ix.com/company/ultragenyx/news/ultragenyx-announces-positive-36-week-data-from-phase-3-study-of-dtx301-aav8-gene-therapy-for-the-treatment-of-ornithine-transcarbamylase-otc-deficiency-13</link>
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<pubDate>Thu, 12 Mar 2026 04:00:00 GMT</pubDate>
<description>Statistically significant improvements in primary endpoint of ammonia control compared with placebo at 36 weeks Clinically important changes observed in</description>
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<title>Ultragenyx Announces U.S. FDA Acceptance and Priority Review of the Biologics License Application (BLA) for DTX401 AAV Gene Therapy for Glycogen Storage Disease Type Ia (GSDIa)</title>
<link>https://6ix.com/company/ultragenyx/news/ultragenyx-announces-us-fda-acceptance-and-priority-review-of-the-biologics-license-application-bla-for-dtx401-aav-gene-therapy-for-glycogen-storage-disease-type-ia-gsdia</link>
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<pubDate>Mon, 23 Feb 2026 13:30:00 GMT</pubDate>
<description>PDUFA action date set for August 23, 2026 If approved, DTX401 will be the first treatment to address the underlying cause of GDSIa NOVATO, Calif., Feb. 23, 2026 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) today announced the U.S. Food and Drug Administration (FDA or the Agency) has accepted for review the Biologics License Application (BLA) seeking approval of DTX401 AAV gene therapy (pariglasgene brecaparvovec) for the treatment of Glycogen Storage Disease Type Ia (GSDIa).</description>
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<title>Ultragenyx Reports Fourth Quarter and Full Year 2025 Financial Results and Corporate Update</title>
<link>https://6ix.com/company/ultragenyx/news/ultragenyx-reports-fourth-quarter-full-210100492</link>
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<pubDate>Thu, 12 Feb 2026 21:01:00 GMT</pubDate>
<description>2025 total revenue of $673 million,Crysvita® revenue of $481 million and Dojolvi® revenue of $96 million 2026 total revenue from current products expected to be between $730 million to $760 million Initiated a strategic restructuring plan to significantly reduce and focus expenses and headcount, reiterate path to profitability in 2027 2026 catalysts include two potential approvals and expected pivotal Phase 3 data from the GTX-102 Phase 3 Aspire study for Angelman syndrome NOVATO, Calif., Feb. 1</description>
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<title>Ultragenyx to Host Conference Call for Fourth Quarter and Full-Year 2025 Financial Results and Corporate Update</title>
<link>https://6ix.com/company/ultragenyx/news/ultragenyx-host-conference-call-fourth-210500565</link>
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<pubDate>Thu, 05 Feb 2026 21:05:00 GMT</pubDate>
<description>NOVATO, Calif., Feb. 05, 2026 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel products for serious rare and ultra-rare genetic diseases, today announced that it will host a conference call at 5:00 p.m. ET on Thursday, February 12, 2026, to discuss its financial results and corporate update for the quarter and the year ending December 31, 2025. The live and replayed webcast of the call will be</description>
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<title>Ultragenyx Announces Positive Longer-Term Data Demonstrating Treatment with UX111 Gene Therapy Results in Sustained, Significant Reductions in CSF-HS and Continued Meaningful Improvements in Clinical Function Across Multiple Developmental Domains in Children with Sanfilippo Syndrome (MPS IIIA)</title>
<link>https://6ix.com/company/ultragenyx/news/ultragenyx-announces-positive-longer-term-130000411</link>
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<pubDate>Tue, 03 Feb 2026 13:00:00 GMT</pubDate>
<description>Data represents up to 8.5 years of follow-up and are consistent across age, dose, and genotype BLA resubmitted to U.S. FDA in January 2026; Company expects up to six-month review period per FDA guidelines NOVATO, Calif., Feb. 03, 2026 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. today announced new long‑term data from clinical studies evaluating UX111 (rebisufligene etisparvovec), an investigational AAV9 gene therapy for Sanfilippo syndrome Type A (MPS IIIA), a fatal neurodegenerative lyso</description>
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<title>Ultragenyx Announces Positive Longer-Term Data Demonstrating Treatment with UX111 Gene Therapy Results in Sustained, Significant Reductions in CSF-HS and Continued Meaningful Improvements in Clinical Function Across Multiple Developmental Domains in C...</title>
<link>https://6ix.com/company/ultragenyx/news/ultragenyx-announces-positive-longer-term-data-demonstrating-treatment-ux111-gene</link>
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<pubDate>Tue, 03 Feb 2026 05:00:00 GMT</pubDate>
<description>Ultragenyx Announces Positive Longer-Term Data Demonstrating Treatment with UX111 Gene Therapy Results in Sustained, Significant Reductions in CSF-HS and</description>
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<title>Ultragenyx Resubmits Biologics License Application for UX111 AAV Gene Therapy to Treat Sanfilippo Syndrome Type A (MPS IIIA) to U.S. FDA</title>
<link>https://6ix.com/company/ultragenyx/news/ultragenyx-resubmits-biologics-license-application-133000463</link>
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<pubDate>Fri, 30 Jan 2026 13:30:00 GMT</pubDate>
<description>Company expects up to six-month review period per FDA guidelines New longer-term clinical data demonstrating durable positive brain biochemical and clinical effect for as long as 8.5 years to be presented at WORLDSymposium™ 2026 NOVATO, Calif., Jan. 30, 2026 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) today announced that it has resubmitted its Biologics License Application (BLA) seeking accelerated approval for UX111 (rebisufligene etisparvovec) AAV9 gene therapy as a trea</description>
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<title>Ultragenyx Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)</title>
<link>https://6ix.com/company/ultragenyx/news/ultragenyx-reports-inducement-grant-under-213000172</link>
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<pubDate>Fri, 23 Jan 2026 21:30:00 GMT</pubDate>
<description>NOVATO, Calif., Jan. 23, 2026 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for rare and ultra-rare diseases, today reported the grant of 16,355 restricted stock units of the company’s common stock to nine newly hired non-executive officers of the company. The awards were approved by the compensation committee of the company’s board of directors and granted under the Ultragenyx Em</description>
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<title>Ultragenyx Provides Financial and Business Updates at J.P. Morgan Annual Healthcare Conference</title>
<link>https://6ix.com/company/ultragenyx/news/ultragenyx-provides-financial-business-updates-123000104</link>
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<pubDate>Mon, 12 Jan 2026 12:30:00 GMT</pubDate>
<description>Preliminary 2025 total revenue of $672 million to $674 million, exceeding top end of guidance Preliminary cash and investments of approximately $735 million as of December 31, 2025 Anticipated 2026 catalysts include two potential approvals and pivotal Phase 3 data from the GTX-102 Phase 3 Aspire study for Angelman syndrome NOVATO, Calif., Jan. 12, 2026 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization o</description>
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<title>Ultragenyx to Present at the 44th Annual J.P. Morgan Healthcare Conference</title>
<link>https://6ix.com/company/ultragenyx/news/ultragenyx-present-44th-annual-j-210500040</link>
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<pubDate>Wed, 07 Jan 2026 21:05:00 GMT</pubDate>
<description>NOVATO, Calif., Jan. 07, 2026 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for serious rare and ultra-rare genetic diseases, today announced that Emil D. Kakkis, M.D., Ph.D., the company's chief executive officer and president, will present at the 44th Annual J.P. Morgan Healthcare Conference on Monday, January 12, 2026, at 10:30 AM PT. The live and archived webcast of the presen</description>
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<title>Ultragenyx Completes Rolling Submission of Biologics License Application (BLA) to U.S. FDA for DTX401 AAV Gene Therapy for Glycogen Storage Disease Type Ia (GSDIa)</title>
<link>https://6ix.com/company/ultragenyx/news/ultragenyx-completes-rolling-submission-biologics-license-application-bla-us-fda</link>
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<pubDate>Tue, 30 Dec 2025 05:00:00 GMT</pubDate>
<description>If approved, DTX401 will be the first therapy approved to treat the underlying cause of GSDIa NOVATO, Calif., Dec. 30, 2025 (GLOBE NEWSWIRE) -- Ultragenyx</description>
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<title>Ultragenyx Announces Phase 3 Orbit and Cosmic Results for Setrusumab (UX143) in Osteogenesis Imperfecta</title>
<link>https://6ix.com/company/ultragenyx/news/ultragenyx-announces-phase-3-orbit-and-cosmic-results-setrusumab-ux143-osteogenesis</link>
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<pubDate>Mon, 29 Dec 2025 05:00:00 GMT</pubDate>
<description>Neither study achieved its primary endpoint of reduction in annualized clinical fracture rate compared to placebo (Orbit) or bisphosphonates (Cosmic) Both</description>
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<title>Tactical Resources Announces Share Consolidation</title>
<link>https://6ix.com/company/ultragenyx/news/tactical-resources-announces-share-consolidation-1</link>
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<pubDate>Wed, 03 Dec 2025 13:30:00 GMT</pubDate>
<description>VANCOUVER, BC / ACCESS Newswire / December 3, 2025 / Tactical Resources Corp. (TSX.V: RARE)(OTC PINK:USREF) ("Tactical" or the "Company"), a mineral exploration and development company, announces that, in connection with the Company's previously announced ...</description>
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<title>Ultragenyx to Participate in Investor Conferences in December</title>
<link>https://6ix.com/company/ultragenyx/news/ultragenyx-participate-investor-conferences-december-2025-11-24</link>
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<pubDate>Mon, 24 Nov 2025 05:00:00 GMT</pubDate>
<description>NOVATO, Calif., Nov. 24, 2025 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and</description>
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<title>Ultragenyx Reports Third Quarter 2025 Financial Results and Corporate Update</title>
<link>https://6ix.com/company/ultragenyx/news/ultragenyx-reports-third-quarter-2025-financial-results-and-corporate-update-2025-11</link>
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<pubDate>Tue, 04 Nov 2025 05:00:00 GMT</pubDate>
<description>Third quarter total revenue of $160 million, Crysvita® revenue of $112 million and Dojolvi® revenue of $24 million Reaffirm 2025 Revenue Guidance: Total</description>
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<title>Ultragenyx Announces Sale of a Portion of Future North American Royalties on Crysvita® (burosumab) for $400 Million to OMERS Life Sciences</title>
<link>https://6ix.com/company/ultragenyx/news/ultragenyx-announces-sale-portion-future-north-american-royalties-crysvitar-burosumab</link>
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<pubDate>Tue, 04 Nov 2025 05:00:00 GMT</pubDate>
<description>Bolsters balance sheet with non-dilutive capital at an attractive cost Beginning in January 2028 OMERS will receive an additional 25% of the North American</description>
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<title>Ultragenyx Announces First Patient Dosed in Aurora Study Evaluating GTX-102 in Additional Angelman Syndrome Genotypes and Age Groups</title>
<link>https://6ix.com/company/ultragenyx/news/ultragenyx-announces-first-patient-dosed-aurora-study-evaluating-gtx-102-additional</link>
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<pubDate>Thu, 30 Oct 2025 04:00:00 GMT</pubDate>
<description>NOVATO, Calif., Oct. 30, 2025 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) today announced that the first patient has been dosed in the</description>
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