Liver – Talk Bio

Patient Hospitalized After Receiving Intellia’s CRISPR Therapy Dies, Prompting FDA Hold on Trials

3 weeks ago talkbio0Tagged Amyloidosis, Clinical Trials, Comorbidity, CRISPR therapy, Intellia, Liver, nex-z, nexiguran ziclumeran, Patient Death, Phase III MAGNITUDE trial, Toxicity aspects, TTR wt Allele, United States Food and Drug Administration

Intellia Therapeutics; CRISPR therapy; nexiguran ziclumeran (nex-z); patient death; liver toxicity; Phase III MAGNITUDE trial; ATTR amyloidosis; clinical trial hold; FDA; comorbidities

FDA Places Clinical Hold on Two Intellia CRISPR Trials After Life-Threatening Liver Toxicity Case

4 weeks ago talkbio0Tagged ATTR-CM, ATTR-PN, Clustered Regularly Interspaced Short Palindromic Repeats, gene therapy, Intellia, Liver, MAGNITUDE trial, Nexiguran, Senile cardiac amyloidosis, Study on Hold, Toxicity aspects, United States Food and Drug Administration, ziclumeran

FDA; Intellia; CRISPR; clinical hold; liver toxicity; nexiguran ziclumeran; MAGNITUDE trial; transthyretin amyloidosis; ATTR-CM; ATTR-PN; gene therapy

Intellia Pauses Two CRISPR Trials After Severe Liver Toxicity Hospitalizes Patient

4 weeks ago talkbio0Tagged Clustered Regularly Interspaced Short Palindromic Repeats, Gene Modification, Hospitalization, Intellia, Liver, Pauses, Phase 3 Clinical Trials, Safety, Senile cardiac amyloidosis, Toxicity aspects

Intellia Therapeutics; CRISPR; transthyretin amyloidosis; Phase III trials; gene editing; liver toxicity; patient hospitalization; safety pause

Inhibrx to Seek FDA Approval in 2026 After Strong Phase 2 Data for Bone Cancer Drug Ozekibart

1 month ago talkbio0Tagged Anti-DR5 Agonistic Monoclonal Antibody INBRX-109, Biological Factors, Chondrosarcoma, Infrequent, Inhibrx, Liver, Malignant Bone Neoplasm, Malignant Neoplasms, ozekibart, Progression-Free Survival, Receptors, Tumor Necrosis Factor, Member 10b, Submission, Toxicity aspects, United States Food and Drug Administration

Inhibrx; FDA submission; ozekibart; INBRX-109; chondrosarcoma; bone cancer; phase 2 clinical trial; progression-free survival; death receptor 5; biologics license application; rare cancer; liver toxicity

FDA Investigates Patient Deaths Linked to Sarepta’s Elevidys Gene Therapy for Duchenne Muscular Dystrophy

5 months ago talkbio0Tagged ELEVIDYS, Evaluation, gene therapy, Liver, Liver Failure, Acute, Muscular Dystrophy, Duchenne, patient deaths, regulatory, Toxicity aspects, Unable to walk (finding), United States Food and Drug Administration

FDA; Sarepta; Elevidys; Duchenne muscular dystrophy; gene therapy; patient deaths; acute liver failure; liver toxicity; regulatory investigation; non-ambulatory patients

Aligos Therapeutics’ HERALD Study Shows Promising MASH Treatment Results, Yet Fails to Impress Investors

1 year ago talkbio0Tagged ALG-055009, Aligos, Clinical Research, HERALD, investor, Liver, MASH, phase 2a

Aligos Therapeutics, HERALD study, MASH treatment, ALG-055009, liver fat reduction, Phase 2a results, investor reaction.

Biomea’s Early-Stage Diabetes Drug Placed on Full Clinical Hold, Stock Plummets

1 year ago talkbio0Tagged Biomea, crash, Diabetes, Liver, Menin Inhibitor BMF-219, Study on Hold, Toxicity aspects, United States Food and Drug Administration

Biomea, diabetes, clinical hold, FDA, BMF-219, liver toxicity, stock crash

Tango Pauses Clinical Trials of Promising Solid Tumor Treatment Due to Liver Toxicity Concerns

2 years ago talkbio0Tagged ARNT gene, aspects of adverse effects, Cancer Research, Clinical Trials, Drug Development, Liver, solid tumor treatment, Toxicity aspects

Tango Therapeutics, solid tumor treatment, clinical trials, liver toxicity, drug development, cancer research, treatment side effects, patient safety.

Boehringer Ingelheim and Ochre Bio Join Forces in a $1 Billion Collaboration to Combat Chronic Liver Diseases

2 years ago2 years ago talkbio0Tagged boehringer ingelheim, Chronic liver disease, Collaboration, Drug Discovery, Fibrosis, Liver, Nonalcoholic Steatohepatitis, RNA

Boehringer Ingelheim, Ochre Bio, collaboration, chronic liver diseases, $1 billion, drug discovery, RNA therapeutics, liver fibrosis, non-alcoholic steatohepatitis (NASH)

FDA Awaits Final Decision on Madrigal’s Resmetirom for NASH Treatment with Priority Review and NDA Acceptance Set for March 14, 2024

2 years ago talkbio0Tagged Fibrosis, Liver, Liver, Madrigal's, March 14, 2024, New Drug Application, Nonalcoholic Steatohepatitis, Priority Review, resmetirom, United States Food and Drug Administration

Nonalcoholic Steatohepatitis, resmetirom, United States Food and Drug Administration, New Drug Application, Priority Review, Fibrosis, Liver, Liver, Madrigal’s, March 14, 2024