RMAT– tag –
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BrainChild Bio Secures $116M, Earns FDA Breakthrough Designations for CAR-T Therapy Against Pediatric Brain Cancer DIPG
Hoodline USA Overview BrainChild Bio, a biotechnology firm spun out of Seattle Children's Hospital, has raised $116 million to advance its novel CAR-T cell therapy for Diffuse Intrinsic Pontine Glioma (DIPG), a devastating pediatric brai... -
Hereditary Transthyretin Amyloidosis Market: Intellia/Regeneron’s CRISPR Gene Editor Nexiguran ziclumeran Receives FDA RMAT Designation
GlobeNewswire USA Overview This article summarizes a market research report by DelveInsight on the hereditary transthyretin amyloidosis (hATTR) market. The report highlights Nexiguran ziclumeran (nex-z), a CRISPR-Cas9-based gene-editing ... -
Ocugen Doses First Patient in Phase 3 Registrational Trial for OCU410 Modifier Gene Therapy for Geographic Atrophy, Following RMAT Designation
GlobeNewswire USA Overview Ocugen has initiated patient dosing in its Phase 3 registrational trial for OCU410, a modifier gene therapy targeting geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD). OCU410 rece... -
Allogene Therapeutics’ TALEN-Edited Lymphoma Cell Therapy cema-cel Receives FDA RMAT and Fast Track Designations, Achieves 58.3% MRD Negativity in Phase 2 Trial
PRISM MarketView USA Overview Allogene Therapeutics' TALEN-edited allogeneic cell therapy, cema-cel, has received both Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the FDA, accelerating its regulatory pa... -
China’s Hopstem Biotech Secures Nearly RMB 200 Million in Series C First Close to Advance iPSC Cell Therapy Pipeline Led by hNPC01
Insight, China's Pharmaceutical Industry China Overview China's Hopstem Biotech has completed the first close of nearly RMB 200 million (approximately $27.5 million USD) in Series C funding to advance its iPSC cell therapy pipeline, led ... -
US FDA Reports Approximately 50% Approval Rate for Regenerative Medicine Advanced Therapy (RMAT) Designations, Totaling 193 Approvals Out of 388 Applications, Highlighting Accelerated Development in Regenerative Medicine
BioInformant (Blog) USA Overview According to a BioInformant blog post, the U.S. FDA has announced the approval of 193 out of 388 total Regenerative Medicine Advanced Therapy (RMAT) designation applications received to date. This indicat... -
Aspen Neuroscience’s Personalized Cell Therapy Sasineprocel (ANPD001) Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for Parkinson’s Disease
Longevity.Technology USA Overview Aspen Neuroscience announced that sasineprocel (ANPD001), its personalized cell therapy for Parkinson's disease, has been granted Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. FDA... -
Allogene Therapeutics’ Off-the-Shelf CAR-T Cema-cel Achieves 58.3% MRD Negativity in ALPHA3 Phase 2 LBCL Trial, Securing FDA RMAT and Fast Track Designations
Allogene Therapeutics, Inc. (Press Release) USA Overview Allogene Therapeutics announced strong Q2 2026 results, highlighting that its off-the-shelf CAR T-cell therapy, cema-cel, achieved a robust 58.3% minimal residual disease (MRD) neg... -
Aspen Neuroscience’s ANPD001 Cell Therapy for Parkinson’s Disease Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation, Signaling Accelerated Development
RegMedNet USA Overview A RegMedNet report indicates that Aspen Neuroscience's ANPD001 cell therapy for Parkinson's disease has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. FDA, based on preliminary Pha... -
U.S. FDA Regenerative Medicine Advanced Therapy (RMAT) Designations: 168 Publicly Announced by 2026, Accelerating Transformative Therapies in Oncology and Rare Diseases
BioInformant USA Overview According to BioInformant, as of August 2026, the U.S. FDA has publicly announced 168 Regenerative Medicine Advanced Therapy (RMAT) designations. These designations are granted to cell and gene therapy products ...
