Intra-Cellular Therapies

Intra-Cellular Therapies, Inc. operates as a biopharmaceutical company. It focuses on the discovery and clinical development of small molecule drugs that address underserved medical needs in neuropsychiatric and neurological disorders by targeting intracellular signaling mechanisms within the central nervous system, or CNS. The firm’s lead product candidate, ITI-007, is in clinical development as a first-in-class treatment for schizophrenia. It also includes pre-clinical programs that are focused on advancing drug candidates for the treatment of cognitive dysfunction, in both schizophrenia and Alzheimer's disease and for disease modification and the treatment of neurodegenerative disorders, including Alzheimer's disease. The company was founded by Paul Greengard and Sharon Mates in 2002 and is headquartered in New York, NY.

Earnings data Q1 2021

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Intra-Cellular Therapies (ITCI) reports stellar Q4 performance and eyes market expansion

Intra-Cellular Therapies (ITCI) delivered strong financial performance in Q4 2022, driven by robust sales growth of CAPLYTA and a focus on expanding clinical programs.
While facing challenges in managing expenses and navigating market dynamics, the company is well-positioned to capitalize on opportunities in new indications and patient education initiatives.
ITCI's strategic investments in innovation and market expansion underscore its commitment to long-term growth and addressing mental health needs through novel treatment options.

Intra-Cellular Therapies reports robust Q1 performance and growth prospects

ITCI's strong Q1 performance driven by CAPLYTA and promising results from lumateperone studies position the company well for future growth.
Addressing unmet needs in MDD and bipolar depression, along with ongoing pipeline progress, showcases ITCI's commitment to innovation in neuropsychiatric treatments.
While facing challenges in market share data and increasing expenses, opportunities lie in expanding sales force, new indications for pipeline programs, and driving awareness for CAPLYTA.

Intra-Cellular Therapies (ITCI) reports strong Q2 performance and expands treatment portfolio

Intra-Cellular Therapies (ITCI) demonstrated robust performance in Q2, driven by strong revenue growth and promising developments in its product portfolio.
The company's financial strength, innovative pipeline, and focus on addressing unmet medical needs position it well for future growth and success.
While facing challenges in revenue guidance clarity and resource allocation, ITCI has opportunities to expand its market reach and improve patient outcomes.
By leveraging its strengths and addressing challenges effectively, Intra-Cellular Therapies (ITCI) can capitalize on opportunities to drive continued growth and innovation.

Intra-Cellular Therapies (ITCI) excels in Q3, eyes market expansion

Intra-Cellular Therapies (ITCI) showcased strong financial performance and growth prospects in Q3 2023, driven by CAPLYTA's success and pipeline advancements.
While the company faces challenges in sustaining growth and navigating regulatory complexities, opportunities in market expansion and innovation are key for future success.
ITCI's focus on expanding indications, clinical advancements, and financial strength position it well for continued growth and leadership in the pharmaceutical industry.

Intra-Cellular Therapies (ITCI) reports robust growth and strategic expansion

Intra-Cellular Therapies (ITCI) delivered a strong performance in 2023, with robust revenue growth and strategic plans for pipeline advancement and market expansion.
The company faces challenges in managing expenses, optimizing market penetration, and navigating competitive dynamics, but opportunities in sales growth and innovation are evident.
Overall, Intra-Cellular Therapies (ITCI) is well-positioned for continued success, with a focus on driving growth through product differentiation and market positioning.

Intra-Cellular Therapies (ITCI) reports strong Q1 earnings and eyes market expansion

Intra-Cellular Therapies (ITCI) delivered strong Q1 2024 earnings driven by robust CAPLYTA sales and positive results in MDD studies, positioning the company for future growth.
With a solid financial position, a broad label strategy, and a focus on pipeline expansion, ITCI is well-equipped to capitalize on market opportunities and drive long-term success.
While facing near-term uncertainties and challenges, ITCI's strategic initiatives and ongoing studies present significant opportunities for expanding its market reach and revenue potential.
Overall, ITCI's commitment to developing innovative medicines and its market acceptance indicate a promising outlook for sustained growth and value creation.

Intra-Cellular Therapies (ITCI) reports robust Q3 performance and eyes market expansion

Intra-Cellular Therapies (ITCI) delivered strong financial performance in Q3 2024, driven by CAPLYTA's sales growth and strategic investments in R&D.
The company's focus on innovation, with new program initiations and pipeline advancements, positions it well for future growth and market expansion.
While facing challenges in a competitive market and cost management, ITCI's solid financial position and promising pipeline offer opportunities for sustained success.

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Intra-Cellular Therapies, Inc. operates as a biopharmaceutical company. It focuses on the discovery and clinical development of small molecule drugs that address underserved medical needs in neuropsychiatric and neurological disorders by targeting intracellular signaling mechanisms within the central nervous system, or CNS. The firm’s lead product candidate, ITI-007, is in clinical development as a first-in-class treatment for schizophrenia. It also includes pre-clinical programs that are focused on advancing drug candidates for the treatment of cognitive dysfunction, in both schizophrenia and Alzheimer's disease and for disease modification and the treatment of neurodegenerative disorders, including Alzheimer's disease. The company was founded by Paul Greengard and Sharon Mates in 2002 and is headquartered in Bedminster, NJ.

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Pooled analysis of 3 randomized, double-blind, pacebo-cotrolled trials supports the safety and the distinct and favorable tolerability profile of lumateperone 42 mg

CAPLYTA® (lumateperone) Schizophrenia Safety and Tolerability Profile Published in the Journal, International Clinical Psychopharmacology

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Intra-Cellular Therapies, Inc. (ITCI) CEO Sharon Mates on Q1 2021 Results - Earnings Call Transcript

Shares of Intra-Cellular Therapies (NASDAQ:ITCI) were unchanged after the company reported Q1 results. Quarterly Results Earnings per share rose 10.96% over the past year to ($0.65), which beat the estimate of ($0.80).

Recap: Intra-Cellular Therapies Q1 Earnings

CAPLYTA supplemental new drug applications (sNDAs) for the treatment of bipolar depression in adults as both monotherapy and adjunctive treatment with lithium or valproate have been accepted for review by the FDA, with a PDUFA target action date of December 17, 2021.

Intra-Cellular Therapies Reports First Quarter 2021 Financial Results and Provides Corporate Update

NEW YORK, May 03, 2021 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental New Drug Applications (sNDAs) for lumateperone, an investigational agent for the treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 17, 2021 for the applications. If approved, CAPLYTA has the potential to be an important medicine for a broad group of patients suffering from these highly prevalent, chronic complex conditions.

Intra-Cellular Therapies Announces FDA Acceptance of CAPLYTA® (lumateperone) sNDAs for the Treatment of Bipolar Depression

Intra-Cellular (ITCI) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

Earnings Preview: Intra-Cellular Therapies (ITCI) Q1 Earnings Expected to Decline

After its recent launch of Caplyta for schizophrenia, Intra-Cellular Therapies is poised to gain Caplyta label expansion for bipolar depression. Aside from three label expansions for Caplyta, the company is innovating other forms of Caplyta.

Intra-Cellular: Substantial Unlocked Value In Caplyta Franchises

Webcast to be Held Tuesday, May 4, 2021 at 2:00 p.m. EDT

Intra-Cellular Therapies Announces Investor Webcast and Presentations on Lumateperone Programs at the Upcoming American Psychiatric Association (APA) Annual Meeting

Board of Directors Nominates Sir Michael Rawlins GBE M.D., FRCP, FMedSci, Former Chairman of the UK's Medicines and Healthcare products Regulatory Agency (MHRA), as a New, Independent Director Board of Directors Nominates Sir Michael Rawlins GBE M.D., FRCP, FMedSci, Former Chairman of the UK's Medicines and Healthcare products Regulatory Agency (MHRA), as a New, Independent Director

Intra-Cellular Therapies Announces Board of Director Nominations in Advance of 2021 Annual Meeting

Our research has demonstrated that the phosphodiesterase type 1 (PDE1) enzyme modulates the immune system by reducing macrophage and microglial activity with demonstrated effects in neuroinflammatory conditions, cancer and cardiac diseases.

Intra-Cellular Therapies Presents Data on Antitumor Effects of Phosphodiesterase I Inhibition in a Preclinical Colorectal Cancer Model at the 2021 American Association for Cancer Research (AACR) Annual Meeting

ITCI has one approved product targeting schizophrenia patients. It has an sNDA filed for a larger indication.

Intra-Cellular: Label Expansion PDUFA Up Ahead

Intra-Cellular Therapies, Inc.'s (ITCI) CEO Sharon Mates on Q4 2020 Results - Earnings Call Transcript

Successfully launched CAPLYTA ® (lumateperone) in late March 2020 and demonstrated strong commercial execution in the midst of COVID-19.

Intra-Cellular Therapies Reports Fourth Quarter and Full-Year 2020 Financial Results And Provides Corporate Update

Intra-Cellular Therapies Inc (NASDAQ: ITCI) expands its pipeline with a new molecular entity, ITI-1284, a sublingually delivered deuterated form of lumateperone. ITI-1284 has been developed in collaboration with Catalent Inc (NYSE: CTLT), using its proprietary Zydis ODT (orally disintegrating tablet) fast-dissolving formulation.

Intra-Cellular Therapies Discloses New Drug Candidate For Dementia Related Episodes

ITI-1284 is a deuterated form of lumateperone delivered sublingually as an orally disintegrating tablet (ODT-SL). ITI-1284 ODT-SL may offer pharmacologic benefits and ease-of-use for patients, particularly in elderly populations.

Intra-Cellular Therapies Announces Expansion of its Pipeline with the Introduction of a New Molecular Entity, ITI-1284

Intra-Cellular Therapies Inc (NASDAQ: ITCI) submits CAPLYTA (lumateperone) supplemental marketing application to the FDA to treat depressive episodes associated with bipolar I or II disorder in adults. The application seeks approval for two indications of CAPLYTA; as monotherapy and as adjunctive therapy with lithium or valproate.

Intra-Cellular Therapies Files US Application For Expanded Use Of Lumateperone In Bipolar Settings

NEW YORK, Feb. 22, 2021 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, announced that it has recently submitted supplemental New Drug Applications (sNDAs) to the U.S. Food and Drug Administration (FDA) for two indications for CAPLYTA (lumateperone): 1) as monotherapy; and 2) as adjunctive therapy with lithium or valproate for the treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults. If approved, CAPLYTA would be the first therapy indicated for the treatment of depressive episodes associated with bipolar I or II disorder both as monotherapy and as adjunctive therapy in adults. The Company anticipates an FDA target action date for the sNDAs in the second half of 2021.

Intra-Cellular Therapies Applies for FDA Approval of CAPLYTA® (lumateperone) for the Treatment of Bipolar Depression

Patients with stable symptoms of schizophrenia were switched from previous antipsychotic medications with no dose titration to CAPLYTA 42 mg for a 6-week treatment duration, then switched back to previous or another approved antipsychotic.

CAPLYTA® (lumateperone) Open-Label Safety Switching Study in Patients with Schizophrenia Published in the Journal, Schizophrenia Research

Investors need to pay close attention to Intra-Cellular Therapies (ITCI) stock based on the movements in the options market lately.

Do Options Traders Know Something About Intra-Cellular Therapies (ITCI) Stock We Don't?

NEW YORK, Jan. 05, 2021 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced that Sharon Mates, Ph.D., Chief Executive Officer and Chairman, is scheduled to present at the 39th Annual J.P. Morgan Healthcare Conference on Tuesday, January 12, 2021 at 9:10 am ET.

Intra-Cellular Therapies to Present at the 39th Annual J.P. Morgan Healthcare Conference

The Company continues expansion of its lumateperone programs with the advancement of a Long-Acting injectable formulation into clinical trials.

Intra-Cellular Therapies Announces the Initiation of Clinical Trials for ITI-LLAI, a Long-Acting Injectable Formulation of Lumateperone for the Treatment of Schizophrenia and for ITI-333, a Novel Treatment for Opioid Use Disorder

After a magnificent performance last year with Caplyta approval for schizophrenia, Intra-Cellular stocks gave up some gains. And it's been trading in cyclical growth spurts of gives and takes. Investors are eyeing Caplyta sales to ascertain that the drug has strong sales prospects. Moreover, they want to see additional catalysts materialize.

News for Intra-Cellular Therapies Stock (ITCI)