Investigational New Drug– tag –
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Sana Biotechnology Targets 2026 IND for iPSC-Derived Hypoimmune Pancreatic Islet Cell Therapy SC451 in Type 1 Diabetes
TipRanks / Sana Biotechnology, Inc. USA Overview Sana Biotechnology updated its investor presentation, emphasizing pipeline advancements, particularly for SC451, an iPSC-derived hypoimmune pancreatic islet cell therapy for Type 1 diabete... -
Cellipont Bioservices Supports Six Cell Therapy Programs Towards 2026 IND Filings, Highlighting CDMO Market Growth
Cellipont Bioservices (via Contract Pharma news) USA Overview Texas-based cell therapy CDMO Cellipont Bioservices announced it is supporting six client projects anticipated to reach Investigational New Drug (IND) submission in 2026. Thei... -
WuXi Biologics Reports 18.4% H1 2026 Revenue Growth and 300 IND Application Capacity Annually, Driven by Low-Cost Strategy
Seeking Alpha China Overview WuXi Biologics announced robust financial results for H1 2026, with revenue increasing by 18.4%, primarily driven by demand for investigational drugs and multi-specific antibodies. The company has expanded it... -
Cellipont Bioservices’ Texas Facility Propels Six Client Cell Therapy Programs to Expected 2026 IND Submissions
PR Newswire (Cellipont Bioservices) USA Overview Cellipont Bioservices, a cell therapy CDMO, announced that its Texas facility has supported six client projects anticipated to reach Investigational New Drug (IND) submission in 2026. This... -
FDA Expands Regulatory Flexibility for Cell and Gene Therapies, Streamlining CMC Requirements to Accelerate Early Clinical Development
Medicinova, Inc. (Facebook) USA Overview The US FDA has announced an expansion of regulatory flexibility for Cell and Gene Therapy (CGT) products, particularly adapting Chemistry, Manufacturing, and Controls (CMC) requirements across the... -
KOLON Biotech Expands Comprehensive CDMO Services in Korea, Specializing in Cell, Gene, and Exosome Therapies
MTEC South Korea Overview KOLON Biotech in South Korea is bolstering its capabilities as a specialized Contract Development and Manufacturing Organization (CDMO) for advanced cell, gene, and exosome therapies. The company offers end-to-e... -
RiboX Therapeutics Receives FDA IND Clearance for RXIM002, the First Circular RNA-Based In Vivo CAR Therapy for Autoimmune Cytopenias
BioSpace USA Overview RiboX Therapeutics has received FDA Investigational New Drug (IND) clearance for RXIM002, a circular RNA (circRNA)-based in vivo CAR therapy targeting autoimmune cytopenias. RXIM002 is the first in vivo CAR therapy ... -
Century Therapeutics Targets Q4 2026 IND Submission for iPSC-Derived CNTY-813 in Type 1 Diabetes, Advances CAR-iT Cell Therapy CNTY-308 Towards Clinical Trials This Year
Century Therapeutics, Inc. (Press Release) USA Overview Century Therapeutics announced that it has completed its pre-IND meeting with the FDA for CNTY-813, an iPSC-derived cell therapy for Type 1 diabetes, targeting an Investigational Ne... -
Fate Therapeutics Initiates Phase 2 Trial for iPSC-Derived Off-the-Shelf CAR T-Cell Therapy FT819 in Lupus Nephritis, Gains FDA IND Approval for Autoimmune FT839
Fate Therapeutics, Inc. (Press Release) USA Overview Fate Therapeutics reported significant advancements in its iPSC-derived off-the-shelf CAR T-cell immunotherapy pipeline, with the first patient dosed in the Phase 2 RECLAIM-LN study of... -
Fate Therapeutics Executives Sell Shares Post-FDA IND Approval for Next-Gen Autoimmune CAR-T Candidate FT839, Market Anticipates Basket Trial Success
TipRanks USA Overview Fate Therapeutics executives engaged in significant insider stock sales following news of the U.S. FDA's Investigational New Drug (IND) approval for FT839, its next-generation off-the-shelf CAR-T candidate for autoi...
