Body Part, Organ, or Organ Component

Biopharma Bites: Teva, Kinaset Funding Wins, Camzyos Teen Approval, Lynk and Lyra’s Mixed Fortunes

2 weeks ago talkbio0Tagged approvals, Biopharma, Camzyos, Clinical, Funding, Kinaset, Lynk, Structure of hippocampal commissure, Teva

Teva; Kinaset; Camzyos; Lynk; Lyra; biopharma funding; clinical approvals

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

3 months 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 Extends Review Period for Rhythm Pharmaceuticals’ Imcivree (Setmelanotide) in Acquired Hypothalamic Obesity

3 months ago talkbio0Tagged Agonist, amendment, goal, Hypothalamic structure, Imcivree, MC4R protein, human, PDUFA, Phase 3 trial, review extension, Rhythm Pharmaceuticals, setmelanotide, United States Food and Drug Administration

Imcivree; Rhythm Pharmaceuticals; FDA; review extension; acquired hypothalamic obesity; setmelanotide; PDUFA goal date; Phase 3 trial; major amendment; MC4R agonist

Vera Therapeutics Announces Full Phase 3 Win for Atacicept in Kidney Disease, Prepares FDA Filing by Year’s End

3 months ago talkbio0Tagged asparagine, Atacicept, autoimmune kidney disease, Blackfoot language, File (record), IGA, IGA Glomerulonephritis, Kidney, Phase 3 trial, Proteinuria, Submission, United States Food and Drug Administration, UPCR, Vera Therapeutics

Vera Therapeutics; atacicept; Phase 3 trial; IgA nephropathy; proteinuria reduction; UPCR; FDA filing; BLA submission; ASN Kidney Week 2025; autoimmune kidney disease

Roche Pays $55M Upfront to Manifold Bio in $2B+ Deal for AI-Guided Next-Gen Brain Shuttles

3 months ago talkbio0Tagged AI drug discovery, BBB, Blood - brain barrier anatomy, Manifold Bio, milestones, Neurological diseases, research, Roche (company), shuttles, therapeutic payloads, upfront payment

Roche; Manifold Bio; blood-brain barrier; BBB shuttles; neurological diseases; AI drug discovery; research deal; upfront payment; milestones; therapeutic payloads

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

3 months 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

3 months 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

3 months 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

Cartography Biosciences Closes $67 Million Series B Round Led by Pfizer to Advance CRC T-cell Engager

4 months ago talkbio0Tagged Antibodies, Biosciences, Cartography, CBI-1214, Cervical Atlas, Colorectal Carcinoma, Neoplasms, Pfizer Ventures, Platform, Series B funding, summit, T-Cell engager

Cartography Biosciences; Series B Funding; Pfizer Ventures; CBI-1214; T-cell engager; colorectal cancer (CRC); ATLAS platform; SUMMIT platform; antibody therapeutics; oncology

Aerska Launches with $21M to Use Brain ‘Shuttles’ for RNAi Delivery in Neurological Diseases

4 months ago talkbio0Tagged Aerska, Alzheimer 's, antibody-oligonucleotide, Blood - brain barrier anatomy, brain shuttles, Gene Silencing, Immunostimulating conjugate (antigen), Irish (ethnic group), Neurological diseases, Parkinson 's, Precision Medicine, RNA Interference

Aerska; Irish biotech; RNA interference (RNAi); brain shuttles; blood-brain barrier; neurological diseases; Alzheimer’s; Parkinson’s; gene silencing; precision medicine; antibody-oligonucleotide conjugates