iRegene Therapeutics’ NouvNeu001 Receives the US FDA RMAT Designation in Parkinson’s Disease

Shots: The US FDA has granted RMAT designation to NouvNeu001 for the treatment of Parkinson's disease The P-I data showed marked improvements in MDS-UPDRS Part III motor scores, as low-dose pts achieved 30.6 (OFF; 52.82% improvement) & 12.9 (ON; 54.67% improvement) points at 12mos. & high-dose pts 23.3 (OFF) & 9.67 (ON) at 9mos., with…

ByRidhi RastogiJanuary 20, 2026

March Biosciences’ MB-105 Receives the Regenerative Medicine Advanced Therapy Designation for R/R CD5+ T-Cell Lymphoma

Shots: The US FDA has granted RMAT designation to MB-105 for the treatment of r/r CD5-positive T-cell lymphoma Designation was based on the ongoing P-II trial, which showed clinical activity with a favorable safety profile; initial data to be presented at ASH’25, with additional updates expected in 2026 March Bio will pursue clinical & commercial…

ByRidhi RastogiNovember 12, 2025

Galapagos Secures the US FDA’s RMAT Designation for GLPG5101 to Treat R/R Mantle Cell Lymphoma

Shots: The US FDA has granted RMAT designation to GLPG5101 for the r/r mantle cell lymphoma (MCL) Designation was supported by P-I/II (ATALANTA-1) trial assessing GLPG5101 [50×106 (DL1), 110×106 (DL2) & 250×106 (DL3)] in r/r B-cell Non-Hodgkin Lymphoma pts, incl. those with MCL Trial demonstrated superior ORR & CR rate as well as favorable safety…

ByRidhi RastogiAugust 6, 2025

iRegene Therapeutics’ NouvNeu001 Receives the US FDA RMAT Designation in Parkinson’s Disease

March Biosciences’ MB-105 Receives the Regenerative Medicine Advanced Therapy Designation for R/R CD5+ T-Cell Lymphoma

Galapagos Secures the US FDA’s RMAT Designation for GLPG5101 to Treat R/R Mantle Cell Lymphoma

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