PRODUCT – Talk Bio

FDA Rejects Sydnexis Myopia Drug for Kids; Chugai to Buy Renalys for $98M Upfront

2 days ago talkbio0Tagged Chugai, Complete Response Letter, methionine, Myopia, Ophthalmology specialty, Pediatric brand name, Renalys, SYD-101, Sydnexis, United States Food and Drug Administration

FDA; SYD-101; Sydnexis; myopia; pediatric; complete response letter; Chugai; Renalys; acquisition; $98M; ophthalmology

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

3 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

Lilly’s Oral GLP-1, Orforglipron, Achieves Two New Clinical Wins in Type 2 Diabetes

2 weeks ago talkbio0Tagged ACHIEVE-1, ATTAIN-2, Clinical Trials, Diabetes Mellitus, Non-Insulin-Dependent, Effectiveness, Eli Lilly, Farxiga, Glucagon-Like Peptide 1, Oral cavity, orforglipron, regulatory submission, Safety, semaglutide, Weight Loss

Lilly; Orforglipron; oral GLP-1; type 2 diabetes; clinical trial; weight loss; regulatory submission; ACHIEVE-1; ATTAIN-2; semaglutide; Farxiga; efficacy; safety

Tubulis Secures $361 Million Series C to Advance Clinical-Stage Antibody-Drug Conjugates (ADCs)

2 weeks ago talkbio0Tagged Antibody-Drug Conjugates, cancer therapeutics, Clinical Trials, Optimization, precision oncology, Series C funding, Solid Neoplasm, therapeutic autologous dendritic cells, TUB-030, TUB-040, Tubulis

Tubulis; Series C funding; antibody-drug conjugates; ADC; precision oncology; cancer therapeutics; TUB-040; TUB-030; solid tumors; clinical trials; biotech; platform optimization

Natera to Present 14 Studies at ESMO, Including IMvigor011 Oral Presentation in Presidential Symposium

2 weeks ago talkbio0Tagged adjuvant Tecentriq, Clinical Oncology, Clinical Trials, ESMO Congress, Molecular residual disease, muscle-invasive bladder cancer, Natera, Precision Medicine, Presidential Symposium, Signatera

Natera; ESMO Congress; IMvigor011 trial; Presidential Symposium; Signatera; molecular residual disease; muscle-invasive bladder cancer; adjuvant Tecentriq; precision medicine; clinical oncology

Star Therapeutics Raises $125M as Bleeding Disorder Therapy Enters Phase III

4 weeks ago talkbio0Tagged Antibody Therapy, Blood Coagulation Disorders, Infrequent, Phase 3 Clinical Trials, Series D financing, Star Therapeutics, VGA039

Star Therapeutics; Series D financing; bleeding disorders; VGA039; Phase III clinical trial; biotech funding; rare diseases; antibody therapy

Enanta Presses Ahead with RSV Drug Zelicapavir Despite Missing Primary Endpoint in Phase IIb Trial

4 weeks ago talkbio0Tagged Clinical Trials, Congestive heart failure, COPD, development aspects, Elderly (population group), Enanta, Hospitalization, Neoplasm Metastasis, Phase II B Trial, primary endpoint, rates, Respiratory syncytial virus, United States Food and Drug Administration, Zelicapavir

Enanta Pharmaceuticals; RSV; zelicapavir; Phase IIb trial; primary endpoint miss; secondary endpoints; clinical trials; FDA Fast Track; elderly; COPD; congestive heart failure; hospitalization rates; future development

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