CGTLive®’s Weekly Rewind – February 13, 2026

Welcome to CGTLive®’s Weekly Rewind! We’ve compiled 5 highlights from this week’s coverage of advances in gene and cell therapies, including FDA actions, notable research, and interviews with experts across the field.

1. FDA Slams REGENXBIO's MPS II Gene Therapy RGX-121 With CRL

FDA objections centered on study population misclassification risk, external control validity, and surrogate end point evidentiary strength.

2. ImmunoLogic, Episode 8: "Surgery Meets Immunotherapy: A One-Two Punch for Breast Cancer" With Julia C. Tchou, MD, PhD, FACS

In episode 8 of ImmunoLogic, Julia C. Tchou, MD, PhD, and the cohosts discussed the potential of combining immunotherapy approaches and surgery in the treatment of breast cancer.

3. American College of Physicians Calls for An End of the Term 'Provider' in Policy Paper

Taysha also disclosed that it has received written alignment from the FDA on elements of a potential BLA strategy for TSHA-102.

4. Ultragenyx Puts BLA for MPS IIIA Gene Therapy UX111 in Front of FDA Again

The new BLA includes “substantial longer-term data on multiple measures of neurologic benefit”, and is aimed at obtaining an accelerated approval for the gene therapy product.

5. 'Paintable' CAR T-Cells

Tchou and the ImmunoLogic cohosts discussed the potential use of ‘paintable’ chimeric antigen receptor (CAR) T-cells for the treatment of pancreatic cancer.