Celldex’s Phase 3 CSU Trial Enrolls 1,939 Patients Six Months Ahead of Plan
Celldex's Phase 3 CSU Trial enrolls 1,939 patients six months ahead of schedule, representing the largest randomized trial in...
Denali Pursues DNL593 Progranulin Replacement in FTD-GRN After Takeda Exit
Denali pursues DNL593 progranulin replacement in FTD-GRN after Takeda exit, with Phase 1/2 data expected by year-end in a...
The Survival Signal That Should Redesign Every RAS-Mutant Pancreatic Trial Running Right Now
Daraxonrasib cut pancreatic cancer mortality nearly in half vs. chemo in the RASolute 302 Phase 3 trial — here's...
Praxis Reports 77% Seizure Reduction in SCN2A Epilepsy Study
Praxis reported 77% placebo-adjusted seizure reduction in SCN2A epilepsy, with all treated patients showing improvements in sleep, motor function,...
Roche to Acquire PathAI for $750M in AI Pathology Deal
Roche acquires PathAI for $750M to integrate AI pathology tools into its diagnostics division and clinical trial infrastructure for...
Navepegritide Shows 5.84 cm/year Growth Velocity in Achondroplasia Trial
Navepegritide shows 5.84 cm/year growth velocity in achondroplasia trial, nearly double placebo at week 52 with clean safety profile...
The FDA’s One-Day Inspection Pilot Will Expose Every Site That Built Readiness for a Five-Day Visit
FDA's April 2026 one-day inspection pilot compresses what sites have 5 days to prove into a single visit—here's what...
Vaxcyte’s VAX-31 Advances With Three Phase 3 Trials Enrolling 6,191 Adults
Vaxcyte's VAX-31 Phase 3 trials enroll 6,191 adults across three fully enrolled studies designed to challenge Prevnar 20 and...
Daraxonrasib Doubles Overall Survival in Second-Line Pancreatic Cancer
Daraxonrasib doubled overall survival in second-line metastatic pancreatic cancer versus chemotherapy in the RASolute 302 trial.
SPARK Just Ran 5,400-Patient Oncology Research Autonomously. Your Trial’s Biomarker Strategy Has Not Caught Up.
SPARK agentic AI validated prognostic biomarkers across 5,400 patients and 18 cancer types—here's what that means for trial enrichment...