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Ultragenyx Wins FDA Approval for FAYUVI, First Sanfilippo Type A Treatment
Ultragenyx Pharmaceutical received full U.S. FDA approval in September 2026 for FAYUVI, also known as UX111, the first-ever treatment for pediatric patients with Sanfilippo syndrome Type A, a previously untreated ultra-rare and fatal neurodegenerative disease. The approval came with a Priority Review Voucher and expands Ultragenyx's commercial gene therapy portfolio and U.S. manufacturing footprint. The FAYUVI clearance follows the accelerated FDA approval of GENGLYCOS, also known as DTX401, for GSDIa in August 2026, giving the company two new gene therapies approved within weeks, each generating its own Priority Review Voucher. Ultragenyx's investment narrative projects $1.2 billion in revenue and $43.8 million in earnings by 2029, with a $27.00 fair value estimate implying 86% upside to the current price. The company's biggest immediate risk remains high cash burn and potential dilution if launches underperform or costs do not come down, with adoption, reimbursement and scaling of the new therapies shaping whether it can move closer to its 2027 profitability goal.
Avantor Expands RIM Single-Use Bioprocessing Portfolio Across APAC
Avantor has expanded the availability of its RIM single-use bioprocessing portfolio across the Asia Pacific region, strengthening its presence in a key biopharma manufacturing market. The portfolio includes single-use consumables such as bioprocessing bags, assemblies, tubing and components, plus mixing and storage hardware, and is manufactured at Avantor's Changzhou, China facility, the company's first single-use production site in APAC. That 2,600-square-meter plant operates under ISO 9001:2015 certification and Good Manufacturing Practice standards, and RIM products are available exclusively to APAC customers. The move aligns with management's broader Revival strategy, and in the second quarter of 2026 the Bioscience & Medtech Products segment posted double-digit order growth and a book-to-bill ratio of 1.1x, with management expecting the segment to return to organic growth in the second half of 2026. Avantor currently has a market capitalization of $10.56 billion, and its shares have gained 38.4% year to date versus 3.4% growth for the industry and a 10.1% rise in the S&P 500.
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Andelyn Begins Commercial Manufacturing of Ultragenyx's FDA-Approved FAYUVI Gene Therapy
Andelyn Biosciences announced it is now manufacturing FAYUVI, Ultragenyx Pharmaceutical Inc.'s FDA-approved gene therapy for Sanfilippo syndrome type A, also known as mucopolysaccharidosis type IIIA, for commercial supply at its Columbus, Ohio facility. The move follows the U.S. Food and Drug Administration's approval of FAYUVI, making it the first FDA-approved gene therapy manufactured using the Andelyn AAV Curator Platform process. Sanfilippo syndrome type A is a rare, fatal lysosomal storage disease that primarily affects the central nervous system and is marked by rapid neurodegeneration beginning in early childhood; it is estimated to affect 3,000 to 5,000 patients worldwide, with a median life expectancy of 15 years. Andelyn Chief Executive Officer Wade Macedone said the company is proud to manufacture an FDA-approved gene therapy for commercial use using an AAV Curator Platform process, calling the milestone a reflection of the purpose behind Andelyn's founding. Andelyn, a full-service FDA-inspected cell and gene therapy commercial CDMO with more than 20 years of experience, has produced clinical and commercial material for more than 500 cGMP batches and 85 global clinical trials.