Rapport’s RAP-219 Shows 22-Day Half-Life, Reshapes Phase 3 Design
RAP-219's revised 22-day half-life extends seizure control weeks past treatment and reshapes Phase 3 design for focal onset seizures.
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.