Research Activity
Star Therapeutics Raises $125M as Bleeding Disorder Therapy Enters Phase III
Star Therapeutics; Series D financing; bleeding disorders; VGA039; Phase III clinical trial; biotech funding; rare diseases; antibody therapy
Merck Makes Strong Case for Winrevair in Earlier-Stage Pulmonary Arterial Hypertension (PAH) Patients After Positive Phase 3 HYPERION Results
Winrevair; Merck; HYPERION study; PAH; sotatercept; clinical worsening; early disease; activin signaling; FDA approval; Phase 3 trial
IO Biotech Sheds 50% of Staff After FDA Blocks Cancer Vaccine Approval Path
IO Biotech; layoffs; cancer vaccine; FDA rejection; Cylembio; Phase 3 trial; melanoma; regulatory setback; cost cutting; clinical trial
Enanta Presses Ahead with RSV Drug Zelicapavir Despite Missing Primary Endpoint in Phase IIb Trial
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
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
Applied Therapeutics; govorestat; CMT-SORD; rare disease; FDA; confirmatory study; clinical trial; regulatory alignment
Eli Lilly Withdraws $1.9B Phase 2b Obesity Trial Before Launching Enrollment
Eli Lilly; obesity drug; tirzepatide; bimagrumab; trial termination; phase 2b; Zepbound; type 2 diabetes; clinical trial; regulatory strategy
uniQure’s Gene Therapy AMT-130 Significantly Slows Huntington’s Progression in Pivotal Trial
Gene therapy; uniQure; AMT-130; Huntington’s disease; clinical trial; disease progression; FDA approval; huntingtin-lowering; neurodegeneration
Placebo Response Trips Up Harmony Biosciences’ Fragile X Drug in Late-Stage Phase 3 Trial
Harmony Biosciences; ZYN002; Fragile X syndrome; Phase 3 trial; placebo response; clinical trial failure; RECONNECT study; transdermal cannabidiol gel
Seres Therapeutics Cuts 25% of Workforce Following FDA Feedback on Microbiome Therapy Trial
Seres Therapeutics; layoffs; microbiome; FDA feedback; SER-155; phase 2 trial; workforce reduction; biopharma; clinical studies; cash runway