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 (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.
Intra-Cellular Therapies has initiated an underwritten public offering of $350 million in common stock. The offering includes an option for underwriters to purchase an additional 15% of shares. It is led by J.P. Morgan, Goldman Sachs, SVB Leerink, and Evercore as joint book-running managers. The offering is subject to market conditions and will follow a Form S-3 shelf registration. Investors are encouraged to review the preliminary prospectus supplement for details. The press release includes forward-looking statements and cautions against undue reliance on them.
Intra-Cellular Therapies, a biopharmaceutical company focused on CNS disorders, announced that CEO Sharon Mates will present at the 2020 RBC Capital Markets Global Healthcare Conference. The presentation is on May 19, 2020, at 9:10 AM ET, and will be accessible via a live and archived webcast on the company's website. Founded on Nobel prize-winning research, Intra-Cellular Therapies develops innovative treatments for complex psychiatric and neurologic diseases.
Intra-Cellular Therapies (Nasdaq: ITCI) will hold its 2020 Annual Meeting of Stockholders virtually on May 27, 2020, at 10:00 a.m. Eastern Time, due to COVID-19. Stockholders of record as of April 6, 2020, can vote and ask questions online. To participate, stockholders must access the meeting at www.meetingcenter.io/238568156 using a 15-digit control number and the password ITCI2020. Beneficial owners need to register in advance with Computershare. Technical support will be available during the meeting.
Intra-Cellular Therapies (ITCI) reported first-quarter 2020 financial results, highlighting net product sales of CAPLYTA at approximately $882,500, a significant increase from $0 in Q1 2019. The company faced a net loss of $47.4 million, or $0.73 per share, compared to a loss of $34.8 million in the prior year. R&D expenses decreased to $16.0 million from $25.0 million. SG&A expenses rose sharply to $34.1 million due to increased commercialization efforts. The company also completed a $295 million public offering, boosting cash reserves to $450.4 million.
FAQ
What is the current stock price of Intra-Cellular Therapies (ITCI)?
What is the market cap of Intra-Cellular Therapies (ITCI)?
What does Intra-Cellular Therapies Inc. specialize in?
What is CAPLYTA®?
How did Intra-Cellular Therapies perform financially in Q3 2023?
What are the latest CAPLYTA sales figures?
What are the goals of Intra-Cellular Therapies' development programs?
What is the forecast for CAPLYTA's net product sales in 2024?
What were the results of Study 501?
What safety information is available for CAPLYTA?
Where is Intra-Cellular Therapies headquartered?
What recent achievements has Intra-Cellular Therapies made?
