Neuren partner Acadia bags FDA go-ahead for new DAYBUE STIX powder for Rett Syndrome
The new powder formulation gives children and adults living with Rett syndrome greater flexibility and choice in dose volume and taste
The new powder formulation gives children and adults living with Rett syndrome greater flexibility and choice in dose volume and taste
The study also showed a clear dose-dependent trend, with the 75 mg QD group outperforming the 50 mg QD cohort
Updated results from the EMBER-3 study showed that the drug -- Inluriyo (imlunestrant) -- as a standalone treatment cut the risk of progression or death by 38%
The positive CHMP opinion is supported by results from the Phase III QUASAR trial
The Phase-2b study is a randomized, double-blind, placebo-controlled trial that will enroll approximately 195 patients across 35 sites in the USA
The Phase 3 HER2CLIMB-05 trial showed a 35.9% reduction in risk for patients treated with TUKYSA
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
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