Fourth quarter 2024 CAPLYTA net product sales grew to $199.2 million, representing a 51% increase over the same period in 2023 Full year 2024 CAPLYTA net product sales were $680.5 million, representing year-over-year growth of 47% The U.S. Food and Drug Administration (FDA) accepted for review the lumateperone supplemental New Drug Application (sNDA) submission for adjunctive treatment of major depressive disorder (MDD)... Read More

BEDMINSTER, N.J., Jan. 10, 2025 (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 has entered into a settlement agreement with Sandoz Inc. (Sandoz) resolving patent litigation related to Intra-Cellular Therapies’ product CAPLYTA® (lumateperone). The... Read More

Presentations complement topline data with new data from two pivotal studies (Studies 501 and 502) evaluating lumateperone as an adjunctive therapy for the treatment of major depressive disorder Data shows robust remission and response efficacy rates in patients taking CAPLYTA Robust improvements in anxiety symptoms were also observed in patients taking CAPLYTA as measured by the Generalized Anxiety Disorder Questionnaire... Read More

The sNDA submission is based on positive results from Studies 501 and 502 demonstrating CAPLYTA’s robust antidepressant efficacy and favorable safety and tolerability profile CAPLYTA, if approved as an adjunctive therapy in MDD, would be indicated for the treatment of three different major psychiatry indications affecting over 30 million adult patients in the US BEDMINSTER, N.J., Dec. 03, 2024 (GLOBE NEWSWIRE) --... Read More

BEDMINSTER, N.J., Nov. 19, 2024 (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 three upcoming investor conferences: Evercore 7th Annual HealthCONx Conference... Read More

Presentations include results from two pivotal studies (Studies 501 and 502) evaluating lumateperone as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) Results show robust efficacy and favorable safety and tolerability profile for CAPLYTA BEDMINSTER, N.J., Nov. 07, 2024 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc . (Nasdaq: ITCI), a biopharmaceutical company focused on the... Read More

The efficacy and safety of CAPLYTA (lumateperone) as a maintenance treatment in adults with schizophrenia was demonstrated in a randomized withdrawal trial The study demonstrated a statistically significant (p=0.0002) longer time to relapse in schizophrenia patients treated with lumateperone compared to placebo BEDMINSTER, N.J., Nov. 05, 2024 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a... Read More

CAPLYTA Q3 2024 net product sales were $175.2 million, compared to $125.8 million for the same period in 2023, representing a 39% increase CAPLYTA’s strong prescription uptake continues: Q3 2024 CAPLYTA total prescriptions increased 38%, versus the same period in 2023 CAPLYTA 2024 net product sales guidance range raised to $665 to $685 million Following a successful pre-supplemental NDA (sNDA) meeting with the U.S. Food and... Read More

NEW YORK, Oct. 17, 2024 (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 it will host a conference call and live webcast discussion at 8:30 a.m. Eastern Time on Wednesday, October 30, 2024, to provide a corporate update and discuss details of the Company's... Read More

Oral and poster presentations of results from Study 501 evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) Poster presentations of post-hoc analyses from Study 403 including the prespecified patient population with MDD or bipolar depression with mixed features who also had anxious distress NEW YORK, Sept. 23, 2024 (GLOBE NEWSWIRE) -- Intra-Cellular... Read More

NEW YORK, Aug. 28, 2024 (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 three upcoming investor conferences: Morgan Stanley 22nd Annual Global Healthcare Conference... Read More

NEW YORK, Aug. 08, 2024 (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 Canaccord Genuity 44th Annual Growth Conference on Tuesday, August 13, 2024 at 12:00... Read More

NEW YORK, Aug. 07, 2024 (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 Sanjeev Narula will join the Company on August 12, 2024 and will serve as Executive Vice President, Chief Financial Officer. Mr. Narula will report to Dr. Sharon Mates, ITCI’s... Read More

CAPLYTA Q2 2024 net product sales were $161.3 million, compared to $110.1 million for the same period in 2023, representing a 46% increase CAPLYTA’s strong prescription uptake continues: Q2 2024 CAPLYTA total prescriptions increased 36%, versus the same period in 2023 CAPLYTA 2024 net product sales guidance raised to $650 to $680 million Announced positive Phase 3 results from Study 501 and Study 502 evaluating lumateperone... Read More

NEW YORK, July 24, 2024 (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 it will host a conference call and live webcast discussion at 8:30 a.m. Eastern Time on Wednesday, August 7, 2024, to provide a corporate update and discuss details of the Company's... Read More

In Study 502, lumateperone 42 mg achieved statistically significant and clinically meaningful results in both the primary and the key secondary endpoints Lumateperone 42 mg met the primary endpoint of change from baseline at Week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score versus placebo (4.5 point reduction v. placebo; p<0.0001; Cohen’s d effect size (ES)=0.56) Lumateperone 42 mg also met the key... Read More

NEW YORK, June 10, 2024 (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 45th Annual Goldman Sachs Global Healthcare Conference on Tuesday, June 11, 2024 at 10:00... Read More

NEW YORK, May 29, 2024 (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 Jefferies Global Healthcare Conference on Wednesday, June 5, 2024 at 11:00 a.m. ET in New... Read More

NEW YORK, May 23, 2024 (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 highlights data presentations at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting being held in Miami, May 28 - 31, 2024. The analyses being presented provide important... Read More

NEW YORK, May 08, 2024 (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 participate in two upcoming investor conferences: 2024 RBC Capital Markets Global Healthcare Conference Tuesday, May 14, 2024 at 10:00 a.m. ET in New York, NY Bank of... Read More

CAPLYTA Q1 2024 net product sales were $144.8 million, compared to $94.7 million for the same period in 2023, representing a 53% increase CAPLYTA’s strong prescription uptake continues: Q1 2024 CAPLYTA total prescriptions increased 39%, versus the same period in 2023 CAPLYTA 2024 net product sales guidance reiterated at $645 - $675 million Announced robust positive Phase 3 results from Study 501 evaluating lumateperone as an... Read More

NEW YORK, April 30, 2024 (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 it will host a conference call and live webcast discussion at 8:30 a.m. Eastern Time on Tuesday, May 7, 2024, to provide a corporate update and discuss details of the Company's... Read More

NEW YORK, April 24, 2024 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq: ITCI) (“Intra-Cellular Therapies”), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced that it has completed the sale of an additional 1,027,397 shares of its common stock at a public offering price of $73.00 per share on April 24, 2024,... Read More

NEW YORK, April 17, 2024 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq: ITCI) (“Intra-Cellular Therapies”), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced the pricing of its previously announced underwritten public offering of 6,849,316 shares of its common stock at a public offering price of $73.00 per... Read More

NEW YORK, April 16, 2024 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq: ITCI) (“Intra-Cellular Therapies”), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced that it has commenced an underwritten public offering of $500 million of shares of its common stock. In connection with the offering, Intra-Cellular... Read More

Lumateperone 42 mg achieved statistically significant and clinically meaningful results in both the primary and the key secondary endpoints Lumateperone 42 mg met the primary endpoint of change from baseline at Week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score versus placebo (4.9 point reduction v. placebo; p<0.0001; Cohen’s d effect size (ES)= 0.61) Lumateperone 42 mg also met the key secondary... Read More

NEW YORK, March 19, 2024 (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 promotion of Michael Halstead, J.D. to the position of President. Mr. Halstead is currently serving as Executive Vice President and General Counsel. In this newly created... Read More

NEW YORK, March 06, 2024 (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 participate in three upcoming investor conferences: Leerink Partners Global Biopharma Conference Tuesday, March 12, 2024 at 10:40 a.m. ET in Miami, FL Jefferies Biotech... Read More

NEW YORK, Feb. 27, 2024 (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 44th Annual TD Cowen Health Care Conference on Tuesday, March 5, 2024 at 11:10 a.m. ET in... Read More

Full year 2023 total revenues of $464.4 million, compared to $250.3 million in 2022 Full year 2023 CAPLYTA net product sales were $462.2 million, representing year-over-year growth of 86%. CAPLYTA fourth quarter 2023 net product sales grew to $131.5 million, a 50% increase over the same period in 2022 In 2023, CAPLYTA total prescriptions achieved strong year-over-year growth of 85% CAPLYTA 2024 net product sales guidance of... Read More

NEW YORK, Feb. 08, 2024 (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 it will host a conference call and live webcast discussion at 8:30 a.m. Eastern Time on Thursday, February 22, 2024, to provide a corporate update and discuss details of the Company's... Read More

NEW YORK, Jan. 02, 2024 (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 42nd Annual J.P. Morgan Healthcare Conference on Tuesday, January 9, 2024 at 8:15 a.m. PT... Read More

Company presents positive results of a pre-specified patient population in Study 403 examining the effects of CAPLYTA ® (lumateperone) in patients experiencing a major depressive episode with anxious distress and mixed features. Company presents preclinical data on ITI-1549, our lead product candidate in our non-hallucinogenic psychedelics program in mood disorders and other psychiatric disorders. NEW YORK, Dec. 05, 2023... Read More

NEW YORK, Nov. 15, 2023 (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 present at the 6th Annual Evercore ISI HealthCONx Conference on Tuesday, November 28, 2023 at 3:25 p.m. ET in Miami, FL. The live and archived webcast can be accessed... Read More

Q3 2023 total revenues increased to $126.2 million, compared to $71.9 million in the same period in 2022 CAPLYTA Q3 2023 net product sales were $125.8 million, compared to $71.9 million for the same period in 2022, representing a 75% increase CAPLYTA’s strong prescription uptake continues: Q3 2023 CAPLYTA total prescriptions increased 71%, versus the same period in 2022 2023 CAPLYTA net product sales guidance raised to $460... Read More

NEW YORK, Oct. 31, 2023 (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 participate in two upcoming investor conferences: J.P. Morgan Equity Opportunities Forum Monday, November 6 – Tuesday, November 7, 2023 in Miami, FL UBS Biopharma... Read More

NEW YORK, Oct. 26, 2023 (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 it will host a conference call and live webcast discussion at 8:30 a.m. Eastern Time on Thursday, November 2, 2023, to provide a corporate update and discuss details of the Company's... Read More

NEW YORK, Sept. 20, 2023 (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 present at the 2023 Cantor Fitzgerald Global Healthcare Conference on Wednesday, September 27, 2023 at 1:15 p.m. ET. The live and archived webcast can be accessed under... Read More

NEW YORK, Sept. 11, 2023 (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 several CAPLYTA data presentations at the 2023 Psych Congress held September 6 - 10, 2023 in Nashville. “We are very excited to share additional lumateperone data including the... Read More

NEW YORK, Sept. 05, 2023 (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 present at the Morgan Stanley 21st Annual Global Healthcare Conference on Tuesday, September 12, 2023 at 12:55 p.m. ET. The live and archived webcast can be accessed... Read More

NEW YORK, Aug. 04, 2023 (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 present at the Canaccord Genuity 43rd Annual Growth Conference on Wednesday, August 9, 2023 at 1:30 p.m. ET. The live and archived webcast can be accessed under "Events &... Read More

Q2 2023 total revenues increased to $110.8 million, compared to $55.6 million in the same period in 2022 CAPLYTA Q2 2023 net product sales were $110.1 million, compared to $55.1 million for the same period in 2022, representing a 100% increase CAPLYTA’s strong prescription uptake continues: Q2 2023 CAPLYTA total prescriptions increased 96%, versus the same period in 2022 and 13% sequentially versus Q1 2023 2023 CAPLYTA net... Read More

NEW YORK, July 28, 2023 (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 it will host a conference call and live webcast discussion at 8:30 a.m. Eastern Time on Thursday, August 3, 2023, to provide a corporate update and discuss details of the Company's... Read More

NEW YORK, June 05, 2023 (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 present at the Goldman Sachs 44th Annual Global Healthcare Conference on Monday, June 12, 2023 at 2:00 p.m. PT. The live and archived webcast can be accessed under "Events... Read More

NEW YORK, May 31, 2023 (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 several CAPLYTA data presentations at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting being held in Miami, May 30 - June 2, 2023. The analyses being presented... Read More

Q1 2023 total revenues of $95.3 million, compared to $35.0 million in the same period in 2022 CAPLYTA Q1 2023 net product sales were $94.7 million, compared to $34.8 million for the same period in 2022, representing a 173% increase Q1 2023 CAPLYTA total prescriptions increased 159%, versus the same period in 2022 and 16% sequentially versus Q4 2022 Reiterating CAPLYTA 2023 net product sales guidance of $430 to $455 million... Read More

NEW YORK, May 02, 2023 (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 present at two upcoming investor conferences: Bank Of America Securities 2023 Health Care Conference Tuesday, May 9, 2023 at 2:20 p.m. PT. (5:20 p.m. ET.) 2023 RBC Capital... Read More

NEW YORK, April 26, 2023 (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 it will host a conference call and live webcast discussion at 8:30 a.m. Eastern Time on Thursday, May 4, 2023, to provide a corporate update and discuss details of the Company's... Read More

NEW YORK, April 11, 2023 (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 22nd Annual Needham Virtual Healthcare Conference on Tuesday, April 18, 2023 at 11:45... Read More

Lumateperone 42mg was statistically significant on the primary endpoint of symptom reduction on the Montgomery Asberg Depression Rating Scale (MADRS) for each patient population including: combined major depressive disorder (MDD) with mixed features and bipolar depression with mixed features (5.7 point reduction v. placebo; p<0.0001; Cohen’s d effect size (ES) = 0.64) MDD with mixed features (5.9 point reduction v. placebo;... Read More

Full year 2022 total revenues of $250.3 million, compared to $83.8 million in 2021 CAPLYTA fourth quarter 2022 net product sales grew to $87.4 million, a 243% increase over the same period in 2021 and a 22% sequential increase over the third quarter 2022 Full year 2022 CAPLYTA net product sales grew to $249.1 million, a 205% increase over 2021 CAPLYTA 2023 net product sales guidance of $430 to $455 million NEW YORK, March... Read More

NEW YORK, Feb. 14, 2023 (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 it will host a conference call and live webcast discussion at 8:30 a.m. Eastern Time on Wednesday, March 1, 2023, to provide a corporate update and discuss details of the Company's... Read More

NEW YORK, Feb. 08, 2023 (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 SVB Securities Global Biopharma Conference on Wednesday, February 15, 2023 at 10:40 a.m.... Read More

NEW YORK, Jan. 03, 2023 (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 41 st Annual J.P. Morgan Healthcare Conference on Monday, January 9, 2023 at 11:15 a.m.... Read More

NEW YORK, Dec. 08, 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 four data presentations at the American College of Neuropsychopharmacology (ACNP) 61st Annual Meeting highlighting the therapeutic use of CAPLYTA for the treatment of bipolar I and II... Read More