CGTLive®’s Weekly Rewind – November 7, 2025

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 Activity Recap: October 2025 Features New Platform Technology Designation, RDEA Pilot Program Selection, and More

Catch up on any of the key FDA news stories you may have missed last month, with coverage highlights from the CGTLive team.

2. PreBLA Meeting With FDA Sinks uniQure’s Hopes for Approval of Huntington Disease Gene Therapy AMT-130 Based Primarily on Phase 1/2 Data

uniQure pointed out that this new feedback stands in contrast to its previous communications with the FDA in several Type B meetings.

3. Quarter Century Update: The Impact of Artificial Intelligence

Deborah Phippard, PhD, and Renier Brentjens, MD, PhD, discussed how AI will affect cell and gene therapy research and practice.

4. Evaluating CAR-T KYV-101 for Generalized Myasthenia Gravis

Naji Gehchan, MD, MBA, the chief medical and development officer of Kyverna Therapeutics, went over new data the company presented at AANEM’s 2025 meeting.

5. What Were the Most Significant Inflection Points or Breakthroughs in Cell and Gene Therapy?

Phippard and Brentjens spoke on major events in the past quarter century of cell and gene therapy research.