Phase III – Talk Bio

METiS BioTech Announces China’s First AI-Enabled Formulation Drug Candidate to Complete Phase III Clinical Trial

2 days ago talkbio0Tagged AiTEM, biotech, China, Clinical, Drug Formulation Process, Metis people, nanodelivery, PBA, Phase III, pseudobulbar, Pseudobulbar affect

METiS BioTech; AI; drug formulation; Phase III; pseudobulbar affect (PBA); China; nanodelivery; AiTEM; clinical milestone

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

AstraZeneca’s Saphnelo Succeeds in Phase III as Self-Injectable Lupus Treatment

1 month ago talkbio0Tagged anifrolumab, AstraZeneca, Clinical Trials, disease activity, Encephalitis, St. Louis, Lupus Erythematosus, Systemic, Phase III, Saphnelo, Self-Injectable, subcutaneous, TULIP-SC trial

AstraZeneca; Saphnelo; anifrolumab; Phase III; TULIP-SC trial; systemic lupus erythematosus; SLE; self-injectable; subcutaneous; clinical trial; disease activity reduction

Priovant Announces Successful Phase III Results for Brepocitinib in Dermatomyositis (VALOR Study)

1 month ago talkbio0Tagged Brepocitinib, Clinical Trials, cutaneous remission, Dermatomyositis, NDA filing, Phase III, Priovant, Roivant, Steroids, Total Improvement Score, Tumor stage Tis, VALOR study

Priovant; Roivant; brepocitinib; Phase III; VALOR study; dermatomyositis; clinical trial; Total Improvement Score; TIS; steroid reduction; cutaneous remission; NDA filing

LB Pharmaceuticals Upsizes IPO to $285M, Marks First Major Biotech Listing in Months

2 months ago talkbio0Tagged IPO, IPOs, LBRX, Nasdaq, Phase III, Pounds, public entity, Schizophrenia

LB Pharmaceuticals; IPO; biotech; $285 million; LBRX; schizophrenia; Phase III; public offering; Nasdaq; 2025 biotech IPOs

Phase III Study: Perioperative Padcev & Keytruda Combo Significantly Improves Survival in Bladder Cancer

2 months ago talkbio0Tagged cisplatin-ineligible, enfortumab, Event-Free Survival, Keytruda, Malignant neoplasm of urinary bladder, muscle-invasive bladder cancer, Overall Survival, Padcev, pembrolizumab, perioperative, Phase III, vedotin

Padcev; Keytruda; enfortumab vedotin; pembrolizumab; phase III; bladder cancer; muscle-invasive bladder cancer; cisplatin-ineligible; perioperative; event-free survival; overall survival

Biogen Ushers Spinraza Follow-Up (Salanersen) Into Pivotal SMA Studies

4 months ago talkbio0Tagged Antistreptolysin O, Biogen, Clinical Trials, motor milestones, Nerve Degeneration, Novartis, Pediatric brand name, Phase III, salanersen, Spinal Muscular Atrophy, Spinraza, Zolgensma

Biogen; SMA; Spinraza; salanersen; Phase III; clinical trials; neurodegeneration; motor milestones; pediatric; Novartis Zolgensma; ASO therapy

Regenxbio Reports Consistent One-Year Benefit for DMD Gene Therapy RGX-202

5 months ago talkbio0Tagged AFFINITY DUCHENNE trial, Biological Markers, Clinical Trials, Functional, gene therapy, Muscular Dystrophy, Duchenne, Phase III, Regenxbio, SLC6A8 Inhibitor RGX-202

Regenxbio; DMD; Duchenne muscular dystrophy; RGX-202; gene therapy; AFFINITY DUCHENNE trial; clinical trial; microdystrophin; biomarker; phase I/II; functional data