$ITCI News

Last published 6mo ago

6mo agoITCIApproval of Caplyta, Nda #209500 (Efficacy)FDA Approved DrugsApproval Date: 04/24/2026; Drug Name: Caplyta, Nda #209500; Active Ingredients: LUMATEPERONE TOSYLATE; Company: Intra-cellular; Submission Status: Approval; Submission Classification: Efficacy; Application Number: 209500
10mo agoITCIINTRA-CELLULAR THERAPIES, INC. - Appeal, ReversedUS Patent Trial and Appeal Board
10mo agoITCIINTRA-CELLULAR THERAPIES, INC. - Appeal, ReversedUS Patent Trial and Appeal Board
1y agoITCI PHATPhathom Pharmaceuticals Reports First Quarter 2025 Financial Results and Provides Business UpdateGlobeNewswireVOQUEZNA launch momentum continues with over 390,000 prescriptions filled to date, written by more than 23,600 healthcare providersNet revenues of $28.5 million reported for Q1Filled VOQUEZNA prescriptions increased ~8%
1y agoITCIIntra-Cellular Therapies Reports Fourth Quarter and Full-Year 2024 Financial ResultsGlobeNewswireFourth 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
1y agoITCI JNJJohnson & Johnson Strengthens Neuroscience Leadership with Acquisition of Intra-Cellular Therapies, Inc.GlobeNewswireAcquisition 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
1y agoITCI JNJJohnson & Johnson Strengthens Neuroscience Leadership with Acquisition of Intra-Cellular Therapies, Inc.Business WireAcquisition 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
1y agoITCIIntra-Cellular Therapies Settles CAPLYTA® (lumateperone) Patent Litigation with SandozGlobeNewswireBEDMINSTER, 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
1y agoITCIIntra-Cellular Therapies to Present at the 43rd Annual J.P. Morgan Healthcare ConferenceGlobeNewswireBEDMINSTER, 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
1y agoITCIIntra-Cellular Therapies Presents Data from the CAPLYTA Adjunctive MDD Phase 3 Program at the American College of Neuropsychopharmacology Annual MeetingGlobeNewswirePresentations 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
1y agoITCIIntra-Cellular Therapies Submits Supplemental New Drug Application (sNDA) to FDA for CAPLYTA® (lumateperone) for the Treatment of Major Depressive Disorder as Adjunctive TherapyGlobeNewswireThe 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
1y agoITCIIntra-Cellular Therapies to Participate in Three Upcoming Investor ConferencesGlobeNewswireBEDMINSTER, 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
2y agoITCIIntra-Cellular Therapies Announces Presentations at the 2024 Psych Congress and NEI CongressGlobeNewswirePresentations 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
2y agoITCIIntra-Cellular Therapies Announces Positive Topline Results in Phase 3 Trial Evaluating CAPLYTA for the Prevention of Relapse in Patients with SchizophreniaGlobeNewswireThe 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)
2y agoITCIIntra-Cellular Therapies, Inc. (ITCI) Q3 2024 Earnings Call TranscriptEarnings Call Transcripts
2y agoITCIIntra-Cellular Therapies Reports Third Quarter 2024 Financial Results, Provides Corporate Update and Raises 2024 Caplyta Sales GuidanceGlobeNewswireCAPLYTA 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
2y agoITCIIntra-Cellular Therapies to Host Third Quarter 2024 Financial Results Conference Call and WebcastGlobeNewswireNEW 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)
2y agoITCIIntra-Cellular Therapies Announces Presentations at the 2024 European College of Neuropsychopharmacology CongressGlobeNewswireOral 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
2y agoITCIIntra-Cellular Therapies to Present at Three Upcoming Investor ConferencesGlobeNewswireNEW 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)
2y agoITCIIntra-Cellular Therapies to Present at the Canaccord Genuity 44th Annual Growth ConferenceGlobeNewswireNEW 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)
2y agoITCIIntra-Cellular Therapies, Inc. (ITCI) Q2 2024 Earnings Call TranscriptEarnings Call Transcripts
2y agoITCIIntra-Cellular Therapies Announces Appointment of Sanjeev Narula as Chief Financial OfficerGlobeNewswireNEW 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)
2y agoITCIIntra-Cellular Therapies Reports Second Quarter 2024 Financial Results, Provides Corporate Update and Raises 2024 CAPLYTA Sales GuidanceGlobeNewswireCAPLYTA 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
2y agoITCIIntra-Cellular Therapies to Host Second Quarter 2024 Financial Results Conference Call and WebcastGlobeNewswireNEW 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)
2y agoITCIIntra-Cellular Therapies Announces Positive Topline Results in Second Phase 3 Trial Evaluating Lumateperone as Adjunctive Therapy in Patients with Major Depressive DisorderGlobeNewswireIn 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
2y agoITCIIntra-Cellular Therapies to Present at the 45th Annual Goldman Sachs Global Healthcare ConferenceGlobeNewswireNEW 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)
2y agoITCIIntra-Cellular Therapies to Present at the Jefferies Global Healthcare ConferenceGlobeNewswireNEW 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)
2y agoITCIIntra-Cellular Therapies Highlights Data Presentations at the American Society of Clinical Psychopharmacology Annual MeetingGlobeNewswireNEW 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)
2y agoITCIIntra-Cellular Therapies to Participate in Two Upcoming Investor ConferencesGlobeNewswireNEW 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)
2y agoITCIIntra-Cellular Therapies, Inc. (ITCI) Q1 2024 Earnings Call TranscriptEarnings Call Transcripts
2y agoITCIIntra-Cellular Therapies Reports First Quarter 2024 Financial ResultsGlobeNewswireCAPLYTA 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
2y agoITCIIntra-Cellular Therapies to Host First Quarter 2024 Financial Results Conference Call and WebcastGlobeNewswireNEW 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)
2y agoITCIIntra-Cellular Therapies Announces Closing of $575 Million Public Offering Including Full Exercise of Underwriters' Option to Purchase Additional SharesGlobeNewswireNEW 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
2y agoITCIIntra-Cellular Therapies Prices Public Offering of Common StockGlobeNewswireNEW 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
2y agoITCIIntra-Cellular Therapies Announces Proposed Public Offering of Common StockGlobeNewswireNEW 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
2y agoITCIIntra-Cellular Therapies Announces Positive Phase 3 Topline Results from Study 501 Evaluating Lumateperone as Adjunctive Therapy in Patients with Major Depressive DisorderGlobeNewswireLumateperone 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
2y agoITCIIntra-Cellular Therapies Announces Executive Appointments and Leadership ChangesGlobeNewswireNEW 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)
2y agoITCIIntra-Cellular Therapies to Participate in Three Upcoming Investor ConferencesGlobeNewswireNEW 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)
2y agoITCIIntra-Cellular Therapies to Present at the 44th Annual TD Cowen Health Care ConferenceGlobeNewswireNEW 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)
2y agoITCIIntra-Cellular Therapies, Inc. (ITCI) Q4 2023 Earnings Call TranscriptEarnings Call Transcripts
2y agoITCIIntra-Cellular Therapies Reports Fourth Quarter And Full-Year 2023 Financial Results And Provides Corporate UpdateGlobeNewswireFull 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
2y agoITCIIntra-Cellular Therapies to Host Fourth Quarter and Full Year 2023 Financial Results Conference Call and WebcastGlobeNewswireNEW 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)
2y agoITCIIntra-Cellular Therapies to Present at the 42nd Annual J.P. Morgan Healthcare ConferenceGlobeNewswireNEW 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)
2y agoITCIIntra-Cellular Therapies Highlights Data Presentations at the American College of Neuropsychopharmacology Annual MeetingGlobeNewswireCompany 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
2y agoITCIIntra-Cellular Therapies to Present at the 6th Annual Evercore ISI HealthCONx ConferenceGlobeNewswireNEW 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)
3y agoITCIIntra-Cellular Therapies Reports Third Quarter 2023 Financial Results and Raises 2023 CAPLYTA Sales GuidanceGlobeNewswireQ3 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,
3y agoITCIIntra-Cellular Therapies to Participate in Two Upcoming Investor ConferencesGlobeNewswireNEW 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)
3y agoITCIIntra-Cellular Therapies to Host Third Quarter 2023 Financial Results Conference Call and WebcastGlobeNewswireNEW 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)
3y agoITCIIntra-Cellular Therapies to Present at the 2023 Cantor Fitzgerald Global Healthcare ConferenceGlobeNewswireNEW 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)
3y agoITCIIntra-Cellular Therapies Announces Presentations at Psych Congress 2023 Including Positive Results from Study 403 in Mixed FeaturesGlobeNewswireNEW 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)