What happened
Shares of Intra-Cellular Therapeutics (ITCI 3.00%) were up 14.8% Tuesday morning after the healthcare company released top-line phase 3 trial information regarding its depression therapy, Caplyta (lumateperone). The drug, administered in a 42-milligram daily dose, met its primary endpoint of a reduction of symptoms on the Montgomery Asberg Depression Rating Scale (MADRS), the company said.
The stock is down more than 12% over the past 12 months but up more than 2% so far in 2023.
So what
Intra-Cellular focuses on therapies to treat central nervous system disorders. The key in the study was Caplyta did well on patients with major depressive disorder (MDD) with mixed features, as well as bipolar depression with mixed features.
Overall, patients saw a 5.7-point reduction on the MADRS 60-point scale of depression severity. The study could mean a big jump up in patients for Caplyta, which is approved to treat schizophrenia as well as episodes of bipolar I and bipolar II depression.
The antipsychotic drug was responsible for most of the company's revenue last year, bringing in $249.1 million, up 205% over 2021. Overall, the biotech company's revenue rose 199% last year to $250.3 million.
Now what
While Intra-Cellular has four drugs in its pipeline, Caplyta is its only drug approved by the Food and Drug Administration (FDA). Adding MDD as well as patients with depression tied to MDD and bipolar depression would significantly increase its patient population.
According to the National Institute of Mental Health (NIMH), there were 21 million adults in the U.S. in 2020 with at least one major depressive episode. Bipolar disorder affects roughly 5.7 million people in the U.S., according to the NIMH. Last year, the company reported a loss of $256.3 million, or $2.72 a share, compared to a loss of $284.1 million, or $3.50 a share, in 2021. The addition of more indications for Caplyta could push the company's finances into the black.
