Bioheng Therapeutics has received FDA clearance for a phase 1b/2 clinical trial of CTD402, a CD7-directed UCAR-T therapy, aimed at treating relapsed/refractory T-cell acute lymphoblastic leukemia/lymphoma, which has shown promising preliminary results.

Capricor Therapeutics' biologics license application for Deramiocel, a cell therapy targeting Duchenne muscular dystrophy cardiomyopathy, has been accepted by the FDA for priority review, with a PDUFA action date set for August 31, 2025.

IN8bio has launched a next-generation gamma-delta T-cell engager platform, INB-600, which aims to enhance T-cell therapies by expanding the gamma-delta T cell response against cancer and autoimmune diseases.

Regeneron's gene therapy DB-OTO has demonstrated improvements in hearing for pediatric patients suffering from otoferlin-related hearing loss during the phase 1/2 CHORD clinical trial.

In a notable application of investigational therapies, NKGen Biotech has treated a patient with frontotemporal dementia using its NK cell therapy, troculeucel, under a compassionate use IND approved by the FDA.

As of March 5, 2025, significant advancements and updates in the biotechnology sector highlight the rapid progress in cell and gene therapies.

Ocugen's gene therapies, OCU410 for geographic atrophy and OCU410ST for Stargardt disease, have garnered positive opinions from the European Medicines Agency's Committee for Advanced Therapies.