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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 (Nasdaq: ITCI) announced a conference call on February 25, 2021, at 8:30 a.m. ET to discuss its financial results for the quarter and year ending December 31, 2020. Investors can access the call by dialing 1-(844) 835-6563 (U.S.) or 1-(970) 315-3916 (international), using conference ID 8499868. The call will also be available as a live and archived webcast on the company's website under the Investor Relations section.
Intra-Cellular Therapies (Nasdaq: ITCI) published positive results from the CAPLYTA clinical trial (ITI-007-303) in patients with stable schizophrenia. The 6-week study demonstrated that CAPLYTA, administered at 42 mg, was well-tolerated with minimal metabolic and extrapyramidal symptoms. Patients experienced stability in schizophrenia symptoms, with low adverse events such as somnolence (6.6%) and headache (5.3%). Notably, mean cholesterol and weight levels decreased during treatment. The findings support CAPLYTA's safety and efficacy, offering valuable insights for clinicians in managing schizophrenia.
Intra-Cellular Therapies (Nasdaq:ITCI) announced that CEO Sharon Mates, Ph.D., will present at the 39th Annual J.P. Morgan Healthcare Conference on January 12, 2021, at 9:10 AM ET. The conference will be accessible via a live and archived webcast on the company's website, requiring registration 5-10 minutes prior to the event.
Intra-Cellular Therapies focuses on developing therapeutics for central nervous system disorders, leveraging Nobel prize-winning research to create innovative treatments for complex psychiatric and neurologic diseases.
Intra-Cellular Therapies has initiated clinical programs for its long-acting injectable formulation of lumateperone and the novel compound ITI-333 for opioid use disorder.
The LLAI formulation is designed for once monthly administration to maintain therapeutic levels in patients with schizophrenia. The Phase 1 study will assess its pharmacokinetics and safety.
ITI-333 aims to treat opioid use disorder with a unique mechanism, showing promise without the safety concerns associated with traditional opioids.
Intra-Cellular Therapies (Nasdaq: ITCI) presented promising findings regarding lumateperone at the 59th Annual Meeting of the American College of Neuropsychopharmacology.
Results from a Phase 3 trial showed significant antidepressant effects of lumateperone in patients with bipolar depression, achieving a p-value of p<.0001 on the Montgomery-Åsberg Depression Rating Scale.
Additional data indicated substantial improvements in depression symptoms among patients with schizophrenia and comorbid depression, with a mean reduction of 4.8 points on the Calgary Depression Scale after one year of treatment.
Intra-Cellular Therapies (Nasdaq:ITCI) announced that CEO Sharon Mates, Ph.D., will participate in a fireside chat at the Evercore ISI 3rd Annual HealthCONx Conference on December 2, 2020, at 9:15 AM ET. Investors can access the live and archived webcast on the company’s Investor Relations website. Intra-Cellular Therapies is a biopharmaceutical firm focusing on developing innovative treatments for central nervous system disorders, leveraging insights from Nobel prize-winning research.
Intra-Cellular Therapies, Inc. (Nasdaq: ITCI) reported positive topline results from Study 402, a Phase 3 trial assessing lumateperone for bipolar depression. The company plans to submit a supplemental NDA to the FDA early 2021. CAPLYTA demonstrated robust commercial performance with a 280% increase in prescriptions from Q2 to Q3 2020. Clinical expansion includes trials in Major Depressive Disorder (MDD) and mixed features of bipolar depression. The third quarter net product sales reached $7.4 million, while the net loss was $55.2 million, a significant increase from $34.9 million in Q3 2019.
Intra-Cellular Therapies (Nasdaq: ITCI) announced a conference call scheduled for November 9, 2020, at 8:30 a.m. ET to discuss financial results for Q3 2020 and provide a corporate update. Investors can join the call by dialing 1-(844) 835-6563 (international: 1-(970) 315-3916) using conference ID 1859956. The call will also be available via a webcast on their website's Investor Relations section. Intra-Cellular Therapies focuses on developing treatments for central nervous system disorders based on Nobel Prize-winning research.
Intra-Cellular Therapies (Nasdaq:ITCI) announces the promotion of Dr. Suresh Durgam to Chief Medical Officer, effective immediately. Dr. Andrew Satlin will leave the position on October 28, 2020, for another opportunity. Dr. Durgam has extensive experience in neuropsychiatric drug development and has successfully led clinical programs for lumateperone, addressing schizophrenia and bipolar depression. He previously contributed to the approval of cariprazine and boasts over 23 years in clinical research, enhancing the company's R&D strategy for CNS disorders.
Intra-Cellular Therapies (ITCI) announced a public offering of 11,666,667 shares of common stock at $30.00 per share, expecting gross proceeds of $350 million before expenses. The offering will close on September 15, 2020, contingent upon customary closing conditions. The underwriters have a 30-day option to purchase an additional 1,750,000 shares. The offering is made under a previously filed shelf registration statement with the SEC.
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