The positive CHMP opinion is supported by results from the Phase III QUASAR trial
At the trial’s pre-specified interim analysis, giredestrant achieved a hazard ratio of 0.70, marking a statistically significant improvement in invasive disease-free survival
The investigational therapy uses SteadyTeq, a proprietary copolymer technology from Medincell designed to release olanzapine steadily over time
Adverse events were similar to placebo, and no AP-101-induced antibody responses were detected
It's a development that marks a potential breakthrough for people living with the rare and debilitating disease Duchenne muscular dystrophy (DMD)
MRI is particularly valuable in pediatric care due to its non-invasive nature
The company is excluding data from the affected sites to maintain the study's integrity
The company also revealed that MK-2214 has received Fast Track Designation from the U.S. Food and Drug Administration
Fresh Phase 1b/2a data highlight the strength of the iberdomide + daratumumab + dexamethasone combination in transplant-deferred or ineligible NDMM
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