FDA Approves Intra-Cellular's Antipsychotic For Bipolar Depression - Intra-Cellular Therapies (NASDAQ:ITCI)

The FDA has approved Intra-Cellular Therapies Inc ITCI Caplyta for depressive episodes associated with bipolar I or II disorder in adults.
The approval for Caplyta comes as monotherapy and as adjunctive therapy with lithium or valproate.
The drug has shown a favorable profile on weight, cardiometabolic parameters, and extrapyramidal symptoms (movement disturbances).
Related content: Benzinga's Full FDA Calendar.
The Company says it is positioned to launch the drug immediately.
The approval is based on two positive Phase 3 studies, which demonstrated statistically significant improvements over placebo for the change from baseline in the Montgomery-Asberg Depression Rating scale (MADRS) total score at week 6.
Caplyta 42 mg also showed a statistically significant improvement in the key secondary endpoint relating to the clinical global impression of bipolar disorder in each study.
Price Action: ITCI shares are up 19.3% at $46.72 during the premarket session on the last check Monday.