Submission – Talk Bio

Cogent Hits Unprecedented Efficacy in Rare Stomach Cancer, Clearing Path to FDA

3 weeks ago talkbio0Tagged bezuclastinib, Cogent Biosciences, Effectiveness, Frequency of Responses, Gastrointestinal Stromal Tumors, Infrequent, Malignant neoplasm of stomach, Progression-Free Survival, second-line treatment, Submission, United States Food and Drug Administration

Cogent Biosciences; bezuclastinib; unprecedented efficacy; rare stomach cancer; gastrointestinal stromal tumor (GIST); FDA submission; second-line treatment; objective response rate; progression-free survival

Cogent Biosciences Soars on Positive Phase 3 PEAK Results in Gastrointestinal Stromal Tumors (GIST)

3 weeks ago talkbio0Tagged bezuclastinib, Clinical Trials, Cogent Biosciences, Frequency of Responses, Gastrointestinal Stromal Tumors, NDA, Phase 3, Progression-Free Survival, Standard (qualifier), Stock Surge, Submission, sunitinib

Cogent Biosciences; bezuclastinib; sunitinib; GIST; Phase 3; progression-free survival; objective response rate; NDA submission; clinical trial; stock surge; standard of care

Ionis Claims Curative Potential for Tryngolza in Severe Triglyceride Disease

3 weeks ago talkbio0Tagged Antisense Oligonucleotides, curative potential, Hypertriglyceridemia, Ionis, Pancreatitis, Acute, Phase 3 Clinical Trials, RNA-targeted therapy, Severe (severity modifier), Submission, Triglycerides, TRYNGOLZA, United States Food and Drug Administration

Ionis; Tryngolza; severe hypertriglyceridemia; curative potential; triglyceride reduction; acute pancreatitis; antisense oligonucleotide; FDA submission; Phase III trial; RNA-targeted therapy

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

4 weeks 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

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

GSK, Spero Reveal Full Phase 3 Data for Oral Antibiotic Tebipenem HBr; Regulatory Filing Set for End of 2025

1 month ago talkbio0Tagged Complicated, cUTIs, HBr, IDWeek, non-inferiority, oral carbapenem, Phase 3 PIVOT-PO trial, Regulatory Filing, SmithKline Beecham, Spero Therapeutics, Submission, United States Food and Drug Administration, Urinary tract infection

GSK; Spero Therapeutics; tebipenem HBr; oral carbapenem; Phase 3 PIVOT-PO trial; complicated urinary tract infections (cUTIs); non-inferiority; IDWeek 2025; regulatory filing; FDA submission

Exelixis’ Kinase Blocker Zanzalintinib Sets New Survival Standard in Third-Line Metastatic Colorectal Cancer, Paving Way for FDA Review

1 month ago talkbio0Tagged Colorectal Carcinoma, Exelixis, kinase inhibitor [EPC], Overall Survival, regorafenib, STELLAR-303 trial, Submission, Tecentriq, Third line treatment, United States Food and Drug Administration, zanzalintinib

Exelixis; zanzalintinib; kinase inhibitor; colorectal cancer; STELLAR-303 trial; Tecentriq; regorafenib; overall survival; third-line therapy; FDA submission

Satellos Advances Duchenne Pill Trial in Children; Idorsia Raises $81 Million

2 months ago talkbio0Tagged Child, Fund Raising, Idorsia, Indonesian language, Muscular Dystrophy, Duchenne, oral small-molecule therapy, Phase 2 clinical trial, SAT-3247, Satellos, Submission, United States Food and Drug Administration

Satellos; Duchenne muscular dystrophy; SAT-3247; Phase 2 clinical trial; children; FDA IND submission; oral small-molecule therapy; Idorsia; fundraising; biotech

Regeneron Prepares U.S. Submission for Garetosmab After Breakthrough Phase III Result in Ultra-Rare FOP

3 months ago talkbio0Tagged bone lesion prevention, Drugs, Orphan, fibrodysplasia, Fibrodysplasia Ossificans Progressiva, Garetosmab, Infrequent, OPTIMA trial, ossificans, Phase III, progressiva, Regeneron, Submission, United States Food and Drug Administration

Regeneron; garetosmab; FOP; fibrodysplasia ossificans progressiva; Phase III; OPTIMA trial; bone lesion prevention; rare disease; FDA submission; orphan drug

Avidity Touts Functional Improvements for DMD Therapy, Clearing Way to FDA

3 months ago talkbio0Tagged Approved, Avidity, Biosciences, Blackfoot language, Breakthrough Therapy, Clinical Trials, Functional, Improvements, Muscular Dystrophy, Duchenne, skipping, Submission, United States Food and Drug Administration

Avidity Biosciences; del-zota; DMD; Duchenne muscular dystrophy; FDA approval; functional improvements; exon 44 skipping; Breakthrough Therapy; clinical trial; BLA submission