Submission – Talk Bio

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

1 week 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

1 month 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

1 month 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

Apnimed Advances FDA Filing after Second Pivotal Win for Oral Sleep Apnoea Drug

3 months ago talkbio0Tagged AD109, Apnimed, aroxybutynin, atomoxetine, Clinical Trials, LunAIRo, oral drug, Sleep Apnea, Obstructive, Submission, SynAIRgy, United States Food and Drug Administration

Apnimed; AD109; obstructive sleep apnea; OSA; oral drug; phase 3 trial; LunAIRo; SynAIRgy; FDA submission; clinical trial; aroxybutynin; atomoxetine

Nuvalent Reports Positive Pivotal Data for ROS1-Targeted Lung Cancer Drug; Rolling FDA Submission Planned

4 months ago talkbio0Tagged ARROS-1 trial, Frequency of Responses, Metastatic malignant neoplasm to brain, Neoplasms, Non-Small Cell Lung Carcinoma, Nuvalent, Protein-tyrosine kinase inhibitor, ROS1-positive Lung Cancer, Submission, United States Food and Drug Administration, zidesamtinib

Nuvalent; ROS1-positive lung cancer; zidesamtinib; FDA submission; ARROS-1 trial; NSCLC; tyrosine kinase inhibitor; objective response rate; brain metastases; oncology

GSK, Spero Report Major Phase 3 Win for UTI Antibiotic; Spero’s Stock Surges

5 months ago talkbio0Tagged Antibiotics, Clinical Trials, Complicated, HBr, PIVOT-PO trial, SmithKline Beecham, Spero Therapeutics, Stock Surge, Submission, United States Food and Drug Administration, Urinary tract infection

GSK; Spero Therapeutics; tebipenem HBr; Phase 3 trial; UTI antibiotic; complicated urinary tract infection; PIVOT-PO trial; stock surge; clinical trial results; FDA submission