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Intra-Cellular's (ITCI) Caplyta Aids Growth, Overdependence a Woe
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Intra-Cellular Therapeutics (ITCI - Free Report) is a biopharma company focused on discovering, developing and commercializing small-molecule drugs for treating neuropsychiatric and neurological disorders.
ITCI has only one marketed drug in its portfolio, marketed as Caplyta (lumateperone), for treating schizophrenia and bipolar disorder in adults.
Caplyta has shown an encouraging uptake since its launch in March 2020.
In December 2021, FDA approved the drug for depressive episodes associated with bipolar I or II disorder in adults as monotherapy and adjunctive therapy with lithium or valproate.
Moreover, in April 2022, the FDA approved two new dosage strengths of Caplyta, 10.5 mg and 21 mg for patients concomitantly taking strong or moderate CYP3A4 inhibitors and 21 mg for patients with moderate or severe hepatic impairment. These new dosage strengths have expanded the eligible patient population for Caplyta.
Post the approvals, Caplyta sales have picked up further, witnessing robust growth in sales and total prescriptions. In the third quarter, Caplyta sales were up 233% year over year, reaching $72 million. Total prescriptions were up 220% year-over-year.
Shares of Intra-cellular have declined 3.3% in the year-to-date period compared with the industry’s fall of 17.9%.
Image Source: Zacks Investment Research
Intra-Cellular is also evaluating Caplyta in several other indications. The candidate is currently being evaluated in three phase III studies evaluating the drug as a treatment for major depressive disorder (MDD), for treating major depressive episodes associated with bipolar I or bipolar II disorder and for relapse prevention in schizophrenic patients. A potential approval in the future is anticipated to boost Intra-Cellular’s top line.
The company is also developing a deuterated form of lumateperone, ITI-1248-ODT-SL, for treating behavioral disturbance in dementia patients, dementia-related psychosis and certain depressive disorders in the elderly. Phase I single and multiple ascending dose studies have been completed. Based on these results, Intra-Cellular expects to begin phase II clinical studies in agitation in patients with probable Alzheimer’s disease, in dementia-related psychosis and certain depressive disorders in the elderly in 2023.
Intra-Cellular’s high dependence on just Caplyta sales for revenues is a concern. It needs a growth opportunity apart from Caplyta.
Other than Caplyta, Intra-Cellular also has two other pipeline candidates in early-stage studies. Lenrispodun (ITI-214) is being developed for Parkinson’s disease and ITI-333 is being developed as a potential treatment for substance use disorders, pain and psychiatric comorbidities, including depression and anxiety. However, both are several years away from commercialization.
Nonetheless, a consistent increase in Caplyta sales, successful label expansion of the drug, and minimal competition in its target market is likely to keep the stock afloat in the long term.
Zacks Rank and Stocks to Consider
Intra-Cellular Therapeutics currently has a Zacks Rank #2 (Buy).
Immunocore’s loss per share estimates for 2022 have narrowed from $1.25 to 97 cents over the past 30 days. The loss per share for 2023 has narrowed from $1.69 to $1.10 in the same time frame.
Earnings of Immunocore beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion. The average earnings surprise for IMCR is 68.34%.
AVEO Pharmaceuticals loss per share estimates for 2022 have narrowed down from 94 cents to 68 cents over the past 30 days. The earnings estimate for 2023 remained steady at improved from 41 cents to 52 cents in the same time frame.
Earnings of AVEO beat estimates in three of the trailing four quarters, while missing the same in the reaming occasion. The average earnings surprise for AVEO is 19.87%.
Eton Pharmaceuticals’ loss per share estimates for 2022 remained steady at 44 cents in the past 30 days. The earnings per share for 2023 have remained steady at a cent in the same time frame.
Earnings of Eton missed estimates in three of the trailing four quarters, while beating the same on the remaining occasion. The average earnings surprise for ETON is 115.63%.
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Intra-Cellular's (ITCI) Caplyta Aids Growth, Overdependence a Woe
Intra-Cellular Therapeutics (ITCI - Free Report) is a biopharma company focused on discovering, developing and commercializing small-molecule drugs for treating neuropsychiatric and neurological disorders.
ITCI has only one marketed drug in its portfolio, marketed as Caplyta (lumateperone), for treating schizophrenia and bipolar disorder in adults.
Caplyta has shown an encouraging uptake since its launch in March 2020.
In December 2021, FDA approved the drug for depressive episodes associated with bipolar I or II disorder in adults as monotherapy and adjunctive therapy with lithium or valproate.
Moreover, in April 2022, the FDA approved two new dosage strengths of Caplyta, 10.5 mg and 21 mg for patients concomitantly taking strong or moderate CYP3A4 inhibitors and 21 mg for patients with moderate or severe hepatic impairment. These new dosage strengths have expanded the eligible patient population for Caplyta.
Post the approvals, Caplyta sales have picked up further, witnessing robust growth in sales and total prescriptions. In the third quarter, Caplyta sales were up 233% year over year, reaching $72 million. Total prescriptions were up 220% year-over-year.
Shares of Intra-cellular have declined 3.3% in the year-to-date period compared with the industry’s fall of 17.9%.
Image Source: Zacks Investment Research
Intra-Cellular is also evaluating Caplyta in several other indications. The candidate is currently being evaluated in three phase III studies evaluating the drug as a treatment for major depressive disorder (MDD), for treating major depressive episodes associated with bipolar I or bipolar II disorder and for relapse prevention in schizophrenic patients. A potential approval in the future is anticipated to boost Intra-Cellular’s top line.
The company is also developing a deuterated form of lumateperone, ITI-1248-ODT-SL, for treating behavioral disturbance in dementia patients, dementia-related psychosis and certain depressive disorders in the elderly. Phase I single and multiple ascending dose studies have been completed. Based on these results, Intra-Cellular expects to begin phase II clinical studies in agitation in patients with probable Alzheimer’s disease, in dementia-related psychosis and certain depressive disorders in the elderly in 2023.
Intra-Cellular’s high dependence on just Caplyta sales for revenues is a concern. It needs a growth opportunity apart from Caplyta.
Other than Caplyta, Intra-Cellular also has two other pipeline candidates in early-stage studies. Lenrispodun (ITI-214) is being developed for Parkinson’s disease and ITI-333 is being developed as a potential treatment for substance use disorders, pain and psychiatric comorbidities, including depression and anxiety. However, both are several years away from commercialization.
Nonetheless, a consistent increase in Caplyta sales, successful label expansion of the drug, and minimal competition in its target market is likely to keep the stock afloat in the long term.
Zacks Rank and Stocks to Consider
Intra-Cellular Therapeutics currently has a Zacks Rank #2 (Buy).
Some stocks to consider in the same sector include Immunocore (IMCR - Free Report) , carrying a Zacks Rank #1 (Strong Buy), AVEO Pharmaceuticals and Eton Pharmaceuticals (ETON - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.
Immunocore’s loss per share estimates for 2022 have narrowed from $1.25 to 97 cents over the past 30 days. The loss per share for 2023 has narrowed from $1.69 to $1.10 in the same time frame.
Earnings of Immunocore beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion. The average earnings surprise for IMCR is 68.34%.
AVEO Pharmaceuticals loss per share estimates for 2022 have narrowed down from 94 cents to 68 cents over the past 30 days. The earnings estimate for 2023 remained steady at improved from 41 cents to 52 cents in the same time frame.
Earnings of AVEO beat estimates in three of the trailing four quarters, while missing the same in the reaming occasion. The average earnings surprise for AVEO is 19.87%.
Eton Pharmaceuticals’ loss per share estimates for 2022 remained steady at 44 cents in the past 30 days. The earnings per share for 2023 have remained steady at a cent in the same time frame.
Earnings of Eton missed estimates in three of the trailing four quarters, while beating the same on the remaining occasion. The average earnings surprise for ETON is 115.63%.