Neurocrine Biosciences has unveiled an educational initiative, ‘What the C@H?!’, to support patients with congenital adrenal hyperplasia (CAH) and healthcare professionals. The initiative aims to provide a platform for sharing experiences, advice, and educational resources related to CAH. The company anticipates submitting a market application for its CAH drug crinecerfont to the FDA in Q2.
Results for: Neurocrine Biosciences
Neurocrine Biosciences’ Phase 2 SAVITRI trial for depression therapy NBI-1065845 has reached its main goals in adults with major depressive disorder. The once-daily oral therapy indicated a statistically significant change from baseline in a clinical measure called the Montgomery-Åsberg Depression Rating Scale at Days 28 (primary) and 56 (secondary) compared to placebo. Neurocrine’s medical chief Eiry Roberts said, “The Phase 2 data are very encouraging, and we look forward to meeting with the FDA to discuss a path into Phase 3 studies.”
Neurocrine Biosciences’ Phase 2 SAVITRI study has demonstrated the efficacy of NBI-1065845 in reducing depressive symptoms in adults with major depressive disorder. The study met its primary and key secondary endpoints, with NBI-1065845 showing statistically significant improvement in Montgomery Åsberg Depression Rating Scale (MADRS) total score at both Day 28 and Day 56 compared to placebo. NBI-1065845 was generally well-tolerated, with headache being the most common adverse event.