News|Articles|September 12, 2025
CGTLive®’s Weekly Rewind – September 12, 2025
Author(s)Noah Stansfield
Review top news and interview highlights from the week ending September 12, 2025.
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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. In Response to FDA’s Release of Full CRL for Deramiocel, Capricor Publishes Full Response to the Agency
Capricor stated that it was not notified in advance by the FDA that the latter would be publishing the CRL publicly on its website.
2. Robert Alexander Wesselhoeft, PhD, on Broader Trends in the RNA Therapeutic Research Landscape
The director of RNA Therapeutics at MGB’s Gene and Cell Therapy Institute expressed optimism for RNA’s potential role in CAR-T therapy, gene editing, and more.
3. Patients With DMD Treated With Avidity Biosciences’ Antibody Oligonucleotide Conjugate Del-Zota Show Functional Improvements
The findings come from patients with DMD44 treated in the phase 1/2 EXPLORE44 clinical trial and the phase 2 EXPLORE44-OLE clinical trial.
4. Standardizing Gene Therapy Care in Duchenne: An Overview of Consensus Guidelines
Mind Moments®, a podcast from our sister site NeurologyLive®, held an exclusive interview with Barry Byrne, MD, PhD.
5. Some Patients Treated in Anixa's Ovarian Cancer CER-T Trial Show Longer Than Expected Survival
The company specifically highlighted that 1 patient who was treated in the trial’s first cohort is still alive at 28 months.
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