Krystal Biotech’s KB707 Receives the US FDA RMAT Designation to Treat Advanced or Metastatic NSCLC

Shots: The US FDA has granted RMAT Designation to KB707 for the treatment of advanced or metastatic NSCLC Designation was supported by the ongoing P-I/II (KYANITE-1) trial assessing KB707 (administered via nebulization) across 7 cohorts: Arms 1-4 as monotx., Arm 5 with Keytruda, Arm 6 with Keytruda & CT & Arm 7 with CT alone…

ByRidhi RastogiFebruary 10, 2026

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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

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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

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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

Krystal Biotech’s KB707 Receives the US FDA RMAT Designation to Treat Advanced or Metastatic NSCLC

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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