Blackfoot language

MoonLake revives FDA push; biotech trio to debut in Hong Kong

2 weeks ago talkbio0Tagged * * Investor Day, Asia, Biological Factors, Blackfoot language, Capital, Hidradenitis Suppurativa, Hong Kong, HS drug approval pathway, immunotherapeutics, License Application, Market, MIRA trial, MoonLake, sonelokimab, Type B meeting, United States Food and Drug Administration, VELA-1 trial, VELA-2 trial

MoonLake Immunotherapeutics; Sonelokimab; Hidradenitis Suppurativa; FDA Type B meeting; Biologics License Application; BLA H2 2026; VELA-1 trial; VELA-2 trial; MIRA trial; HS drug approval pathway; investor day February 23 2026; Hong Kong biotech IPOs; Hong Kong listing; Asia biotech capital markets

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

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

5 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

Outlook Therapeutics Faces New FDA Setback for First Ophthalmic Avastin Formulation

5 months ago talkbio0Tagged AMD, Attitude, Avastin, bevacizumab, Blackfoot language, Clinical Trials, Eight, Glycogen storage disease type II, Lytenava, New-onset refractory status epilepticus, ophthalmic formulation, Rejection, resubmission, United States Food and Drug Administration

Outlook Therapeutics; Avastin; bevacizumab; Lytenava; wet AMD; FDA rejection; NORSE EIGHT; BLA resubmission; ophthalmic formulation; clinical trial

IO Biotech’s cancer vaccine Cylembio narrowly misses Phase III primary endpoint in advanced melanoma, but company eyes FDA filing in 2025

6 months ago talkbio0Tagged biotech, Blackfoot language, Clinical Trials, Cylembio, Drops - Drug Form, etimupepimut, Hazard Ratio, Io satellite, Keytruda, melanoma, Overall Survival, P-Value, pembrolizumab, Phase 3, Progression-Free Survival, United States Food and Drug Administration

Cylembio; IO Biotech; melanoma; Phase 3; pivotal trial; progression-free survival (PFS); hazard ratio 0.77; p-value 0.056; Keytruda (pembrolizumab); FDA BLA; overall survival (OS) trend; IOB-013/KN-D18; NCT05155254; imsapepimut; etimupepimut; stock drop

Sangamo Therapeutics Aligns with FDA on Accelerated Approval Pathway for ST-920 Gene Therapy in Fabry Disease

1 year ago talkbio0Tagged Accelerated, approval pathway, Blackfoot language, Fabry Disease, gene therapy, Sangamo, ST-920, Submission, United States Food and Drug Administration

Sangamo Therapeutics, FDA, Accelerated Approval Pathway, ST-920, Fabry Disease, Gene Therapy, BLA Submission

Eisai and Biogen Overcome Filing Hitch, Initiate FDA Submission for Subcutaneous Leqembi

2 years ago talkbio0Tagged Alzheimer 's disease, Amyloid beta-Peptides, Biogen, Blackfoot language, Clinical Trials, Eisai, Leqembi, Monoclonal Antibodies, rolling, subcutaneous, Submission, United States Food and Drug Administration

Eisai, Biogen, FDA submission, Leqembi, subcutaneous, Alzheimer’s disease, rolling submission, BLA, clinical trials, monoclonal antibody, amyloid beta, neurodegenerative disorder