Welcome to our dedicated page for Intra-Cellular Therapies news (Ticker: ITCI), a resource for investors and traders seeking the latest updates and insights on Intra-Cellular Therapies stock.
Intra-Cellular Therapies Inc. (Nasdaq: ITCI) is a pioneering biopharmaceutical company headquartered at 3960 Broadway, New York, New York, United States. The company is dedicated to developing novel, small-molecule drugs to treat diseases of the central nervous system (CNS), focusing on neuropsychiatric and neurological disorders.
Core Business and Products:
Intra-Cellular Therapies leverages proprietary chemistry platforms to create innovative treatments for complex psychiatric and neurologic conditions. Its flagship product, CAPLYTA® (lumateperone), is approved for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorder. CAPLYTA's efficacy is believed to stem from its dual action on serotonin 5-HT2A receptors and dopamine D2 receptors.
Recent Achievements:
- Q3 2023 Financial Performance: The company reported a significant revenue increase to $126.2 million, a 75% rise from the same period in 2022.
- CAPLYTA Sales Growth: CAPLYTA's net product sales surged by 75% in Q3 2023, reaching $125.8 million, demonstrating strong prescription uptake.
- 2023 Net Product Sales Guidance: The company raised its CAPLYTA net product sales guidance to $460-470 million.
- Positive Study Results: At the American College of Neuropsychopharmacology (ACNP) Annual Meeting, the company presented positive results for CAPLYTA in patients with major depressive disorder (MDD) and bipolar disorder with anxious distress and mixed features.
- Phase 3 Study Success: In April 2024, Intra-Cellular Therapies announced robust positive Phase 3 results from Study 501, evaluating lumateperone as an adjunctive therapy for MDD.
Financial Condition and Outlook:
Intra-Cellular Therapies continues to show strong financial performance. For the full year 2023, the company reported total revenues of $464.4 million, up from $250.3 million in 2022. CAPLYTA's net product sales for 2023 were $462.2 million, an 86% year-over-year growth. The company has provided a 2024 net product sales guidance of $645 to $675 million.
Partnerships and Future Projects:
Intra-Cellular Therapies has strategic partnerships with several leading financial institutions, including J.P. Morgan, Leerink Partners, BofA Securities, Morgan Stanley, and RBC Capital Markets, to support its growth and financing strategies. The company is also advancing its pipeline, with upcoming CAPLYTA Phase 3 readouts in adjunctive MDD and additional lumateperone development programs.
Commitment to Safety:
Intra-Cellular Therapies emphasizes the safety and tolerability of its products. CAPLYTA has a favorable safety profile, with the most common adverse reactions being somnolence, dizziness, nausea, and dry mouth. The company remains vigilant in monitoring and communicating any potential risks associated with its therapies.
For more detailed information, please visit the company's official website: www.intracellulartherapies.com
Intra-Cellular Therapies reported a significant revenue growth of 178% in total revenues for Q2 2022, reaching $55.6 million, up from $20.0 million in Q2 2021. CAPLYTA net product revenues were $55.1 million, a 190% increase year-over-year and 58% over Q1 2022. Key metrics include a 225% rise in new prescriptions compared to Q2 2021. However, net loss escalated to $86.6 million from $68.7 million in the prior year. Cash reserves stood at $679.2 million as of June 30, 2022.
Intra-Cellular Therapies (Nasdaq: ITCI) announced a conference call on August 9, 2022, at 8:30 a.m. ET to discuss the financial results for Q2 2022 and provide a corporate update. Interested parties can join the call by dialing 1-(877) 407-8291 or accessing the webcast on the company's website. Intra-Cellular Therapies focuses on developing therapeutics for CNS disorders, utilizing innovative research to create solutions for complex psychiatric and neurologic diseases.
Intra-Cellular Therapies (ITCI) has presented new data regarding lumateperone (CAPLYTA) at the 2022 ISBD virtual conference. Key highlights include efficacy findings from Study 404, demonstrating significant improvements in depression scores (MADRS) and quality of life metrics in patients with bipolar depression. Lumateperone's favorable metabolic profile was also emphasized, showing stabilization of metabolic syndrome rates compared to placebo. Dr. Suresh Durgam expressed satisfaction with the positive feedback from the medical community regarding the drug's efficacy and safety.
Intra-Cellular Therapies reported strong first-quarter 2022 results, highlighting a 120% revenue increase to $35 million compared to Q1 2021. CAPLYTA (lumateperone) saw a remarkable prescription growth, with new prescriptions up 300% post-approval for bipolar depression, and total prescriptions rising 63% from Q4 2021. Net product revenues for CAPLYTA reached $34.8 million, a 123% year-over-year increase. However, a net loss of $72.1 million was reported, up from $52.7 million in the prior year, alongside escalating R&D and SG&A expenses.
Intra-Cellular Therapies (Nasdaq: ITCI) announced a conference call on May 10, 2022, at 8:30 a.m. ET to discuss its financial results for Q1 2022, ending March 31. The company focuses on developing therapeutics for central nervous system disorders, leveraging Nobel prize-winning research to create innovative treatments for psychiatric and neurologic diseases. Interested parties can join via phone or webcast, with dial-in details provided for participants.
Intra-Cellular Therapies has received FDA approval for two new dosage strengths of CAPLYTA (lumateperone): 10.5 mg and 21 mg. These adapt dosage recommendations for patients on moderate or strong CYP3A4 inhibitors and those with moderate to severe hepatic impairment. CAPLYTA is indicated for the treatment of schizophrenia and bipolar depression, demonstrating efficacy with a favorable safety profile. The new dosages will be available mid-2022, further enhancing the medicine's accessibility for specific patient populations.
Intra-Cellular Therapies, Inc. (Nasdaq: ITCI) announced the appointment of E. Rene Salas to its Board of Directors, where he will also serve on the audit committee. With over 35 years in financial and life sciences advisory roles, Salas brings valuable experience, having previously worked at Ernst & Young, LLP and served as CFO of Wellstat, LLC. His expertise is expected to support Intra-Cellular's growth and mission to develop innovative CNS therapies, enhancing operational oversight and strategic direction.
Intra-Cellular Therapies, a biopharmaceutical company focused on CNS disorders, announced that CEO Sharon Mates will present at the 21st Annual Needham Virtual Healthcare Conference on April 12, 2022, at 11:00 am ET. The presentation will be accessible live and archived on the company's website under the Investor Relations section. The company's innovative treatments are based on Nobel prize-winning research aimed at understanding cell interactions. For more details, visit www.intracellulartherapies.com.
Intra-Cellular Therapies received FDA approval for CAPLYTA® (lumateperone) as the first treatment for bipolar depression in adults. In Q4 2021, the company reported total revenues of $25.7 million, a 106% increase year-over-year, with CAPLYTA net product revenues at $25.5 million. For the full year, total revenues reached $83.8 million, up 267%. Despite strong revenue growth, the net loss for 2021 was $284.1 million, reflecting increased R&D and SG&A expenses. CAPLYTA prescriptions rose 15% in Q4 compared to Q3 2021, showcasing strong demand.
Intra-Cellular Therapies (Nasdaq: ITCI) announced a conference call on March 1, 2022, at 8:30 a.m. ET to discuss its corporate updates and financial results for the year ending December 31, 2021. To participate, dial 1-(844) 835-6563 or 1-(970) 315-3916 internationally, using conference ID 5899935. The presentation will be available live and archived in the Investor Relations section on their website. Founded on Nobel prize-winning research, Intra-Cellular focuses on innovative treatments for CNS disorders.
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