Intra-Cellular Therapies, Inc., a biopharmaceutical company, develops novel drugs for the treatment of neuropsychiatric and neurologic diseases, and other disorders of the central nervous system (CNS) in the United States. The company offers CAPLYTA for the treatment of schizophrenia in adults. It is also developing lumateperone, which is in Phase 3 clinical trials for the treatment of bipolar depression, as well as to treat autism spectrum disorder, and sleep disorders associated with neuropsychiatric and neurological disorders. In addition, the company is developing ITI-002 that inhibits the enzyme phosphodiesterase type 1; ITI-214 for the treatment of Parkinson's disease and heart failure; ITI-1284 for the treatment of neuropsychiatric disorders and behavioral disturbances in dementia; and ITI-333, for substance use disorders, pain, and psychiatric comorbidities, including depression and anxiety. Intra-Cellular Therapies, Inc. is headquartered in New York, New York.
IPO Year:
Exchange: NASDAQ
Website: intracellulartherapies.com
| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 9/6/2024 | $68.00 → $92.00 | Neutral → Overweight | Piper Sandler |
| 1/3/2024 | $83.00 | Outperform | Robert W. Baird |
| 12/11/2023 | $75.00 | Outperform | TD Cowen |
| 4/20/2023 | $80.00 | Overweight | Morgan Stanley |
| 8/22/2022 | $64.00 → $49.00 | Buy → Neutral | Goldman |
| 7/7/2022 | $74.00 | Buy | Mizuho |
| 6/14/2022 | $75.00 | Buy | UBS |
| 4/22/2022 | $59.00 | Neutral | Piper Sandler |
| 3/2/2022 | $50.00 → $65.00 | Outperform | SVB Leerink |
| 2/25/2022 | $59.00 → $65.00 | Buy | Needham |
DFAN14A - Intra-Cellular Therapies, Inc. (0001567514) (Subject)
DEFA14A - Intra-Cellular Therapies, Inc. (0001567514) (Filer)
DEFA14A - Intra-Cellular Therapies, Inc. (0001567514) (Filer)
8-K - Intra-Cellular Therapies, Inc. (0001567514) (Filer)
8-K - Intra-Cellular Therapies, Inc. (0001567514) (Filer)
8-K - Intra-Cellular Therapies, Inc. (0001567514) (Filer)
144 - Intra-Cellular Therapies, Inc. (0001567514) (Subject)
8-K - Intra-Cellular Therapies, Inc. (0001567514) (Filer)
10-Q - Intra-Cellular Therapies, Inc. (0001567514) (Filer)
8-K - Intra-Cellular Therapies, Inc. (0001567514) (Filer)
Acquisition includes CAPLYTA® (lumateperone), the first and only U.S. FDA-approved treatment for bipolar I and II depression as an adjunctive and monotherapy; also approved for the treatment of schizophrenia in adults sNDA submitted to U.S. FDA for CAPLYTA® as adjunctive treatment for major depressive disorder; if approved, CAPLYTA® has potential to become a standard of care for most common depressive disorders CAPLYTA® adds to Johnson & Johnson's robust lineup of therapies with $5 billion+ potential in peak year salesi and further solidifies sales growth above analyst expectations now through the remainder of the decade Promising clinical-stage pipeline with best-in-disease potent
Acquisition includes CAPLYTA® (lumateperone), the first and only U.S. FDA-approved treatment for bipolar I and II depression as an adjunctive and monotherapy; also approved for the treatment of schizophrenia in adults sNDA submitted to U.S. FDA for CAPLYTA® as adjunctive treatment for major depressive disorder; if approved, CAPLYTA® has potential to become a standard of care for most common depressive disorders CAPLYTA® adds to Johnson & Johnson's robust lineup of therapies with $5 billion+ potential in peak year salesi and further solidifies sales growth above analyst expectations now through the remainder of the decade Promising clinical-stage pipeline with best-in-disease potential
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 litigation, which is pending in the U.S. District Court for the District of New Jersey, resulted from submission by Sandoz of an Abbreviated New Drug Application to the U.S. Food and Drug Administration seeking approval to market a generic equivalent of CAPLYTA in the Un
BEDMINSTER, N.J., Jan. 06, 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 Sharon Mates, Ph.D., Chief Executive Officer and Chairman, is scheduled to present at the 43rd Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2025 at 11:15 a.m. PT in San Francisco, CA. The live and archived webcast can be accessed under "Events & Presentations" in the Investors section of the Company's website at www.intracellulartherapies.com. Please log in approximately 5-10 minutes prior to the event to register and
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 (GAD-7) Pooled safety and tolerability data from Studies 501 and 502 show favorable safety and tolerability profile for CAPLYTA consistent with prior studies A post-hoc analysis from Study 403 in mixed features shows CAPLYTA significantly improved anhedonia symptoms as
The sNDA submission is based on positive results from Studies 501 and 502 demonstrating CAPLYTA's robust antidepressant efficacy and favorable safety and tolerability profileCAPLYTA, 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) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, announced that it has recently submitted a supplemental New Drug Application (sNDA) to the U.S
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 ConferenceTuesday, December 3, 2024 at 10:50 a.m. ET in Miami, FL Citi 2024 Global Healthcare ConferenceWednesday, December 4, 2024 at 3:15 p.m. ET in Miami, FL Piper Sandler 36th Annual Healthcare ConferenceThursday, December 5, 2024 at 11:30 a.m. ET in New York, NY A live and achie
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 development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced presentations about lumateperone including the results from Phase 3 adjunctive Major Depressive Disorder (MDD) Studies 501 and 502 at Psych Congress held O
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 biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced positive results from Study 304 evaluating the efficacy and safety of lumateperone 42 mg for the prevention of relapse in adult pat
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 Drug Administration (FDA), the lumateperone sNDA submission for adjunctive treatment of major depressive disorder (MDD) is anticipated in the fourth quarter of 2024 Patient enrollment ongoing in ITI-1284 Phase 2 studies in generalized anxiety disorder
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 Chairman and Chief Executive Officer. Lawrence Hineline, who currently serves as Chief Financial Officer, will retire on the same date but will continue to serve as a consultant to the Company for a period of time to ensure a smooth transition. "I am excited to welcome Mr.
NEW YORK, April 21, 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 appointment of E. Rene Salas to the Intra-Cellular Therapies Board of Directors. Mr. Salas will serve as a member of the audit committee. "We are pleased to welcome Rene Salas to the Intra-Cellular Therapies Board," said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies. "Rene's extensive financial and life sciences advisory experience will be very valuable as we continue to grow our business and pursue our mission to develop innova
Cibus, a leading agricultural biotechnology company, announced today the appointment of Rory Riggs, co-founder, and Chairman of Cibus, to serve as Chief Executive Officer. He will succeed Peter Beetham, PhD, also a Cibus co-founder, who has been appointed President and Chief Operating Officer of the 20-year-old company. "Since our founding, Rory has been an important strategic partner in the success of Cibus and we are pleased that he is deepening his involvement in the company's growth as CEO," said Dr. Beetham. "With the recent progress toward a European approval of Cibus' proprietary precision gene-editing technology, as well as other recent Cibus commercial announcements, this manageme
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4 - Intra-Cellular Therapies, Inc. (0001567514) (Issuer)
4 - Intra-Cellular Therapies, Inc. (0001567514) (Issuer)
4 - Intra-Cellular Therapies, Inc. (0001567514) (Issuer)
4 - Intra-Cellular Therapies, Inc. (0001567514) (Issuer)
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Piper Sandler upgraded Intra-Cellular Therapies from Neutral to Overweight and set a new price target of $92.00 from $68.00 previously
Robert W. Baird initiated coverage of Intra-Cellular Therapies with a rating of Outperform and set a new price target of $83.00
TD Cowen initiated coverage of Intra-Cellular Therapies with a rating of Outperform and set a new price target of $75.00
Morgan Stanley initiated coverage of Intra-Cellular Therapies with a rating of Overweight and set a new price target of $80.00
Goldman downgraded Intra-Cellular Therapies from Buy to Neutral and set a new price target of $49.00 from $64.00 previously
Mizuho initiated coverage of Intra-Cellular Therapies with a rating of Buy and set a new price target of $74.00
UBS initiated coverage of Intra-Cellular Therapies with a rating of Buy and set a new price target of $75.00
Piper Sandler initiated coverage of Intra-Cellular Therapies with a rating of Neutral and set a new price target of $59.00
SVB Leerink reiterated coverage of Intra-Cellular Therapies with a rating of Outperform and set a new price target of $65.00 from $50.00 previously
Needham reiterated coverage of Intra-Cellular Therapies with a rating of Buy and set a new price target of $65.00 from $59.00 previously
Acquisition includes CAPLYTA® (lumateperone), the first and only U.S. FDA-approved treatment for bipolar I and II depression as an adjunctive and monotherapy; also approved for the treatment of schizophrenia in adults sNDA submitted to U.S. FDA for CAPLYTA® as adjunctive treatment for major depressive disorder; if approved, CAPLYTA® has potential to become a standard of care for most common depressive disorders CAPLYTA® adds to Johnson & Johnson's robust lineup of therapies with $5 billion+ potential in peak year salesi and further solidifies sales growth above analyst expectations now through the remainder of the decade Promising clinical-stage pipeline with best-in-disease potent
Acquisition includes CAPLYTA® (lumateperone), the first and only U.S. FDA-approved treatment for bipolar I and II depression as an adjunctive and monotherapy; also approved for the treatment of schizophrenia in adults sNDA submitted to U.S. FDA for CAPLYTA® as adjunctive treatment for major depressive disorder; if approved, CAPLYTA® has potential to become a standard of care for most common depressive disorders CAPLYTA® adds to Johnson & Johnson's robust lineup of therapies with $5 billion+ potential in peak year salesi and further solidifies sales growth above analyst expectations now through the remainder of the decade Promising clinical-stage pipeline with best-in-disease potential
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 Drug Administration (FDA), the lumateperone sNDA submission for adjunctive treatment of major depressive disorder (MDD) is anticipated in the fourth quarter of 2024 Patient enrollment ongoing in ITI-1284 Phase 2 studies in generalized anxiety disorder
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 financial results for the quarter ended September 30, 2024. To attend the live conference call by phone please use this registration link. All participants must use the link to complete the online registration process in advance of the conference call. The live and arc
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 as an adjunctive therapy to antidepressants in patients with major depressive disorder (MDD) Supplemental NDA (sNDA) submission for lumateperone as an adjunctive therapy to antidepressants in patients with MDD anticipated in the second half o
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 financial results for the quarter ended June 30, 2024. To attend the live conference call by phone please use this registration link. All participants must use the link to complete the online registration process in advance of the conference call. The live and archived w
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 secondary endpoint of change from baseline at Week 6 on the Clinical Global Impression Scale for Severity of Illness (CGI-S) (p<0.0001; ES=0.51) Statistically significant efficacy was also seen in the Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR) s
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 financial results for the quarter ended March 31, 2024. To attend the live conference call by phone please use this registration link. All participants must use the link to complete the online registration process in advance of the conference call. The live and archived webc
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 endpoint of change from baseline at Week 6 on the Clinical Global Impression Scale for Severity of Illness (CGI-S) (p<0.0001; ES= 0.67) Statistically significant efficacy was seen at the earliest time point tested (Week 1) and maintained throughout the study in both
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 $645 to $675 million NEW YORK, Feb. 22, 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