July 23, 2025 – Talk Bio

CorestemChemon; ATG Lifetech; organoids; transcriptomics; preclinical CRO; drug discovery; predictive analytics; tumorigenicity; FDA/EMA regulatory pathways; liver organoids; heart organoids; blood-brain barrier models

Abivax aces pair of phase 3 ulcerative colitis trials as end of cash runway looms

2 days ago talkbio0Tagged Abivax, ABTECT-1, ABTECT-2, cash runway, clinical remission, induction trials, maintenance trial, Obefazimod, Oral cavity, Ulcerative Colitis

Abivax; Obefazimod; ulcerative colitis; Phase 3 trial; clinical remission; ABTECT-1; ABTECT-2; cash runway; induction trials; oral miR-124 enhancer; maintenance trial

Dispatch Bio Launches with $216M and CAR-T Pioneer Carl June to Advance Universal Solid Tumor Immunotherapy

2 days ago talkbio0Tagged Arch of foot, Cancer Therapeutic Procedure, CAR-T, Carl June, Dispatch Bio, Flare platform, Funding, Immunotherapy, Parker Institute for Cancer Immunotherapy, Partner in relationship, Series, Solid Neoplasm, venture

Dispatch Bio; solid tumors; immunotherapy; CAR-T; Carl June; Series A funding; Flare platform; Parker Institute for Cancer Immunotherapy; ARCH Venture Partners; universal cancer treatment

Lack of Transparency Tarnishes Sarepta’s Sheen as Patient Deaths Trigger FDA Battle

2 days ago talkbio0Tagged ELEVIDYS, gene therapy, lack of transparency, Market, Muscular Dystrophies, Limb-Girdle, Muscular Dystrophy, Duchenne, patient deaths, Regulatory Action, United States Food and Drug Administration, Withdraw (activity)

Sarepta Therapeutics; Elevidys; patient deaths; FDA; lack of transparency; gene therapy; market withdrawal; regulatory action; limb-girdle muscular dystrophy (LGMD); Duchenne muscular dystrophy

Sarepta Therapeutics Faces FDA Crackdown after Third Patient Death; George Tidmarsh Named Top FDA Drug Regulator; Multiple Drugs Rejected; Pharma Invests Billions in US Manufacturing

2 days ago talkbio0Tagged drug rejection, ELEVIDYS, gene therapy, George Tidmarsh, Liver Failure, Acute, pharmaceutical manufacturing, reshoring, Study on Hold, United States Food and Drug Administration

Sarepta Therapeutics; FDA; gene therapy; Elevidys; acute liver failure; clinical hold; George Tidmarsh; drug rejection; reshoring; pharmaceutical manufacturing

Scancell’s Cancer Vaccine Supercharges Melanoma Immunotherapy in Recent Trials

3 days ago talkbio0Tagged Cancer Vaccines, checkpoint inhibitors, Clinical Trials, Immunotherapy, iSCIB1 +, melanoma, Melanoma TRP2 CTL Epitope Vaccine SCIB1, Scancell, SCOPE trial

Scancell; SCIB1; iSCIB1+; melanoma; cancer vaccine; immunotherapy; checkpoint inhibitors; clinical trial; SCOPE trial