Wire · opportunities
Andelyn and Its Curator® Platform Achieve First FDA-Approved Commercial Gene Therapy ...
◆ Sectors
◆ Geography
◆ Source
◆ Verified
Fusion42 · 21 September 2026 · Fusion42 review
Andelyn Biosciences has achieved a regulatory milestone by manufacturing the FDA-approved gene therapy FAYUVI™ for commercial supply, marking the first use of its AAV Curator® Platform in commercial gene therapy manufacturing. This follows the FDA approval of Ultragenyx's FAYUVI™ for treating Sanfilippo syndrome type A, a rare fatal lysosomal disease.
This Wire brief sits within Fusion42's coverage of Biotech, and 3 sources have reported it between 18 Sep 2026 and 21 Sep 2026.
◆ ◆ The Wire takeaway
You now have a commercially validated manufacturing route for AAV gene therapies via Andelyn’s platform, cutting uncertainty in scaling FDA-approved treatments. Prepare to engage with commercial CDMOs who can deliver under regulatory standards for rare disease programs.
◆ Coverage
3 sources · first reported 18 Sep 2026 · latest 21 Sep 2026
◆ Related on Wire
◆ Topics