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Andelyn and Its Curator Platform Achieve First FDA-Approved Commercial Gene Therapy ...

Published

18 September 2026

Topic

opportunities

◆ Sectors

Biotech

◆ Geography

United States

◆ Source

Read at firstwordpharma.com →

◆ Verified

Fusion42 · 19 September 2026 · Fusion42 review

Andelyn Biosciences has started commercial manufacturing of FAYUVI™, the first FDA-approved gene therapy for Sanfilippo syndrome type A, using its proprietary AAV Curator® Platform at its Columbus, Ohio facility following FDA approval.

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 should explore partnerships or customers seeking FDA-approved gene therapy manufacturing as Andelyn sets a commercial precedent with its AAV Curator® Platform. This opens supply chain access in rare disease gene therapies that you can tap into now.

◆ Coverage

3 sources · first reported 18 Sep 2026 · latest 21 Sep 2026

◆ Related on Wire

◆ Topics

Biotechgene-therapycdmofda-approvalmanufacturingrare-disease