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.

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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.

Intra-Cellular Therapies' (ITCI) CEO Sharon Mates on Q4 2021 Results - Earnings Call Transcript

Received FDA approval for CAPLYTA ® (lumateperone) for the treatment of bipolar depression in adults.

Intra-Cellular Therapies Reports Fourth Quarter and Full-Year 2021 Financial Results and Provides Corporate Update

Intra-Cellular Therapies (ITCI) is seeing favorable earnings estimate revision activity and has a positive Zacks Earnings ESP heading into earnings season.

Why Earnings Season Could Be Great for Intra-Cellular Therapies (ITCI)

NEW YORK, Feb. 22, 2022 (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 it will host a conference call and live webcast discussion at 8:30 a.m. Eastern Time on Tuesday, March 1, 2022, to provide a corporate update and discuss details of the Company's financial results for the quarter and year ended December 31, 2021.

Intra-Cellular Therapies to Host Fourth Quarter and Full Year 2021 Financial Results Conference Call and Webcast

Intra-Cellular (ITCI) possesses the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

Intra-Cellular Therapies (ITCI) Expected to Beat Earnings Estimates: What to Know Ahead of Q4 Release

NEW YORK, Feb. 10, 2022 (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 11th Annual SVB Leerink Global Healthcare Conference on Thursday, February 17, 2022 at 8:40 am ET.

Intra-Cellular Therapies to Present at the 11th Annual SVB Leerink Global Healthcare Conference

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Intra-Cellular (ITCI) witnessed a jump in share price last session on above-average trading volume. The latest trend in earnings estimate revisions for the stock doesn't suggest further strength down the road.

Strength Seen in Intra-Cellular (ITCI): Can Its 9.8% Jump Turn into More Strength?

NEW YORK, Jan. 07, 2022 (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 the completion of its previously announced underwritten public offering of 9,523,810 shares of its common stock at a public offering price of $42.00 per share. In addition, the underwriters have exercised in full their option to purchase an additional 1,428,571 shares.

Intra-Cellular Therapies Announces Closing of $460 Million Public Offering Including Full Exercise of Underwriters' Option to Purchase Additional Shares

The company is floating at least $400 million worth of its common stock.

Why Intra-Cellular Therapies Took a Big Hit Today

Intra-Cellular Therapies Inc (NASDAQ: ITCI) commenced an underwritten public offering of $400 million of shares. Underwriters have an option to purchase up to an additional 15% of the shares of common stock offered in the public offering.

IntraCellular Seeks To Raise $400M Via Equity To Fund Commercialization Of Schizophrenia Med

Intra-Cellular Therapies is rewarding shareholders while bringing stellar medicine to patients suffering from psychiatric conditions. As a differentiated neuroleptic, Caplyta demonstrated robust efficacy with minimal side effects.

Intra-Cellular: Unlocking Value With FDA Approval

Intra-Cellular Therapies received FDA approval of CAPLYTA for the treatment of adults with bipolar depression. Total revenues of CAPLYTA in Q3 2021 for treatment of adults with Schizophrenia surged by 200% to $22.1 million compared to the same time period in the prior year.

Intra-Cellular's Second FDA Win Makes It A Great Long-Term Investment

The FDA has approved Intra-Cellular Therapies Inc (NASDAQ: 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.

FDA Approves Intra-Cellular's Antipsychotic For Bipolar Depression

CAPLYTA is the only FDA-approved treatment for depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults as monotherapy and as adjunctive therapy with lithium or valproate.

Intra-Cellular Therapies Announces U.S. FDA Approval of CAPLYTA® (lumateperone) for the Treatment of Bipolar Depression in Adults

NEW YORK, Dec. 06, 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, mourns the passing of one of our Directors, Richard Lerner, MD, a scientific leader who contributed many research discoveries and technologies that have had major impacts on science and medicine. Dr. Lerner served on the board of directors of Intra-Cellular Therapies since the company's formation in 2002.

Intra-Cellular Therapies Mourns the Passing of Director, Dr. Richard Lerner

Intra-Cellular Therapies, Inc. (ITCI) CEO Sharon Mates on Q3 2021 Results - Earnings Call Transcript

Intra-Cellular Therapies (NASDAQ:ITCI) reported its Q3 earnings results on Tuesday, November 9, 2021 at 08:00 AM. Here's what investors need to know about the announcement.

Intra-Cellular Therapies: Q3 Earnings Insights

CAPLYTA supplemental new drug applications (sNDAs) for the treatment of bipolar depression are under review by the FDA, with a PDUFA target action date of December 17, 2021.

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

As a stellar neuroleptic, Caplyta demonstrated robust efficacy and an excellent safety profile. Intra-Cellular Therapies is expanding Caplyta's label for bipolar depression as well as other indications.

Intra-Cellular Therapies: A Leader In The Psychiatric Medicine Space

NEW YORK, Nov. 02, 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 it will host a conference call and live webcast discussion at 8:30 a.m. Eastern Time on Tuesday, November 9, 2021, to provide a corporate update and discuss details of the Company's financial results for the quarter ended September 30, 2021.

Intra-Cellular Therapies to Host Third Quarter 2021 Financial Results Conference Call and Webcast

Virtual event to include discussions on our lumateperone, ITI-1284, PDE1 inhibitors and ITI-333 platforms

Intra-Cellular Therapies to Host a Virtual Event to Feature Highlights of Several of its Development Programs

Shares of Intra-Cellular Therapies Inc. ITCI, -1.12% gained 1.5% in premarket trading on Monday after the company said clinical data showed that its experimental treatment for bipolar disorder reduced depressive symptoms. The Phase 3 study evaluated Caplyta, which is already approved as a treatment for schizophrenia, in 381 people with bipolar I or bipolar II disorder who were experiencing a depressive episode.

Intra-Cellular says clinical study shows its schizophrenia drug helps patients with bipolar disorder

In this study, lumateperone 42 mg showed significant reduction in depressive symptoms compared to placebo in patients with a major depressive episode associated with bipolar I or bipolar II disorder and a favorable safety and tolerability profile. These anti-depressant effects were statistically significant in both bipolar I and bipolar II disorder subgroup populations

Intra-Cellular Therapies Announces Publication of Lumateperone Pivotal Phase 3 Study in Bipolar Depression in The American Journal of Psychiatry

Results of Study ITI-214-104 show that lenrispodun, in a Phase 1/2a Study, is well tolerated and acts as an inodilator in patients with heart failure without inducing abnormal heart rhythms (Circulation: Heart Failure; Gilotra, et al, 2021)

Intra-Cellular Therapies Announces Publications Highlighting Beneficial Effects of Phosphodiesterase Type I Inhibition with Lenrispodun (ITI-214) on Cardiovascular Function in Patients with Heart Failure and in Models of Accelerated Aging

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