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Neurocrine Biosciences (NBIX) investor relations material
Neurocrine Biosciences TD Cowen's 5th Annual Novel Mechanisms in Neuropsychiatry & Epilepsy Summit summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
Evolving R&D strategy and portfolio focus
Shifting R&D strategy to emphasize internal discovery alongside in-licensing, with increased focus on new modalities such as proteins, monoclonal antibodies, and peptides, and prioritizing clinically or genetically validated targets.
Targeting neurology, psychiatry, endocrinology, and immunology, with a central focus on CNS and brain-related diseases.
Portfolio expected to rebalance over time toward 40-50% neurology, 20-30% psychiatry, and 10-20% each for endocrinology and immunology, aiming for higher probability therapeutic areas.
Goal to initiate at least four new phase I, two new phase II, and maintain three phase III programs annually, targeting one new medicine every other year.
Key clinical programs and data updates
NBI-770, an NR2B negative allosteric modulator for major depressive disorder, aims to match ketamine's efficacy with fewer side effects; phase II data expected in October-November, focusing on rapid onset and a 3-4 point MADRS change by day five.
Osavampator, an AMPA potentiator, showed strong efficacy and safety in phase II, with effect sizes up to 0.75 and minimal side effects; phase III trials are ongoing, with primary endpoint at day 56 to capture increasing efficacy over time.
NBI-568 (dracoledine) for schizophrenia demonstrated robust phase II results with a 7.5-point placebo-corrected PANSS improvement and effect size of 0.61; phase III trials are underway with a simplified design and data expected in 2027.
Next-generation VMAT2 inhibitors (NBI-890, NBI-675) are in phase I, aiming for improved compliance and efficacy, including long-acting injectable options.
Commercial performance and outlook
Combined Q2 revenue from CRENESSITY and INGREZZA reached $682 million, a 17% year-over-year increase, with record prescription growth and expanding market share.
Strong advocacy and physician support, along with robust R&D and commercial execution, position the company as a leading neuroscience player.
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