Functional Concept – Page 2

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

MoonLake shares crash after mixed results in pivotal hidradenitis suppurativa studies

1 month ago talkbio0Tagged Bimzelx, Clinical Trials, Cosentyx, drug approval outlook, drug market, Hidradenitis Suppurativa, inhibitors, Interleukin-17, MoonLake Immunotherapeutics, Placebos, Response process, sonelokimab

MoonLake Immunotherapeutics; Sonelokimab; hidradenitis suppurativa; Phase 3 trial; clinical trial results; biotech shares; placebo response; drug approval outlook; IL-17 inhibitors; Bimzelx; Cosentyx; drug market potential

New Confirmatory Study Suggests Progress in Applied Therapeutics–FDA Alignment for Rare Disease Drug

1 month ago talkbio0Tagged Apply, Clinical Trials, CMT-SORD, confirmatory study, Govorestat, Infrequent, regulatory alignment, United States Food and Drug Administration

Applied Therapeutics; govorestat; CMT-SORD; rare disease; FDA; confirmatory study; clinical trial; regulatory alignment

Biogen Shuffles Staff and Exits AAV Gene Therapy Programs After Strategic Shift

1 month ago talkbio0Tagged AAVS1 gene, Biogen, Biotech Layoffs, Discontinuation (procedure), gene therapy, layoffs, Pharma, staff reorganization

Biogen; AAV gene therapy; layoffs; staff reorganization; biotech layoffs; pharma restructuring; gene therapy discontinuation

BMS Breaks Clinical Losing Streak with Positive Phase 3 Myeloma Readout for Iberdomide

1 month ago talkbio0Tagged CELMoD, Clinical Trials, EXCALIBER-RRMM, iberdomide, Minimal Residual Disease Negativity, Multiple Myeloma, Myers, Phase 3, Progression-Free Survival, Protein Degradation, Metabolic, Relapsing course, squibb, Unresponsive to Treatment

Bristol Myers Squibb; iberdomide; multiple myeloma; clinical trial; EXCALIBER-RRMM; minimal residual disease negativity; CELMoD; protein degradation; progression-free survival; phase 3; relapsed or refractory