---
title: CRO Daily News — July 22, 2026
slug: daily-news-2026-07-22-cro
site: cro
post_kind: news
byline: BioBM
description: July 22 CRO daily: SK pharmteco Advances AAV Gene Therapy to Phase III with 20 Clinical Batches for Genethon DMD Program — SK pharmteco's demonstrated ability…
canonical_url: https://www.cro.directory/posts/daily-news-2026-07-22-cro
published_at: 2026-07-22T23:59:24.280Z
last_updated: 2026-07-23T00:03:29.742Z
---

### SK pharmteco Advances AAV Gene Therapy to Phase III with 20 Clinical Batches for Genethon DMD Program
- SK pharmteco's Yposkesi French facility has manufactured 20 AAV8 batches (18 cGMP) at 400 L scale to support Genethon's GNT-0004 DMD gene therapy through Phase III authorization by EMA and MHRA in 2025.
- The partnership demonstrates viral vector CMC, analytical validation, and clinical supply capabilities; SK pharmteco is now manufacturing additional batches while preparing commercial-scale documentation and process validation.
- Long-term efficacy and safety data presented at ASGCT 2026 showed sustained improvements in muscle function over two years, supporting continued enrollment in the 72-patient Phase III trial.

**Operational Impact**

SK pharmteco's demonstrated ability to manufacture 400 L cGMP AAV batches and transition from clinical to commercial-scale documentation strengthens its competitive position in viral vector CDMO services for late-stage gene therapy programs in Europe and beyond.

*Source: [PharmaSource RSS](https://pharmasource.global/content/news/cdmo-news/sk-pharmteco-supports-genethon-gene-therapy-program-through-phase-iii-manufacturing)*

## References

1. [PharmaSource RSS — SK pharmteco Advances AAV Gene Therapy to Phase III with 20 Clinical Batches for Genethon DMD Program](https://pharmasource.global/content/news/cdmo-news/sk-pharmteco-supports-genethon-gene-therapy-program-through-phase-iii-manufacturing)

Source: https://www.cro.directory/posts/daily-news-2026-07-22-cro