Cell Therapy
Capricor Claims FDA Misinterpreted Efficacy Data Leading to Rejection of DMD Therapy
Capricor Therapeutics; FDA rejection; deramiocel; Duchenne muscular dystrophy (DMD); efficacy data misinterpretation; clinical trial endpoints; HOPE-2 trial; non-parametric test; statistical significance; cell therapy
Appia Bio Shuts Down Before Reaching Clinical Trials Amid Biotech Funding Crunch
Appia Bio; cell therapy; biotech shutdown; funding challenges; clinical trials; Kite Pharma partnership; oncology; biotech closures; IND application
Funding Drought Puts Pressure on Cell Therapy Startups Like Appia Bio
Appia Bio; cell therapy; funding drought; biotech; venture capital; Series A financing; ACUA platform; CAR-iNKT cells
Recent Advances for Confident Cell Line Transfer
cell line development; cell transfer; clone stability; electroporation; transfection; quality assurance; GMP compliance; cell therapy
Gilead’s Kite to Acquire Interius for $350M, Advancing In Vivo CAR-T Therapy
Gilead; Kite; Interius BioTherapeutics; CAR-T therapy; in vivo CAR-T; acquisition; off-the-shelf cell therapy; $350 million; biotech; Yescarta; Tecartus; cell therapy platform
Genentech to End $2B Cell Therapy Collaboration with Adaptive Biotechnologies
Genentech; Adaptive Biotechnologies; cell therapy; collaboration termination; T-cell receptor; TruTCR platform; personalized cancer therapy; $2 billion deal
BioNTech to Cut 90 More US Jobs Amid Strategic Realignment
BioNTech; layoffs; job cuts; R&D; pipeline focus; Gaithersburg; Cambridge; cell therapy; post-COVID market; strategic alignment
Galapagos Considers Sale of Cell Therapy Unit in Ongoing Strategic Overhaul
Galapagos; cell therapy; sale; strategic alternatives; pipeline pruning; biotech; spinout; Gilead Sciences; GLPG5101; mantle cell lymphoma; business development
How Data Secrecy Is Stalling Progress in Cell and Gene Therapy (2025)
data secrecy; cell therapy; gene therapy; data sharing; intellectual property; patient privacy; regulatory barriers
FDA Rejects Capricor’s Cell Therapy for Duchenne Muscular Dystrophy
FDA rejection; Capricor Therapeutics; deramiocel; Duchenne muscular dystrophy; DMD; cell therapy; cardiomyopathy; clinical data; Phase 3 HOPE-3 trial; Complete Response Letter