ITCI - Earnings announcements

VOQUEZNA 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% in Q1 over the prior quarter despite seasonal headwindsStrategic cost reductions and executive leadership changes implemented to support sustainable revenue growth and achieve profit from operations, excluding stock-based compensation, in 2026Management to host conference call today, May 1, 2025, at 8:00 a.m. ET FLORHAM PARK, N.J., May 01, 2025 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (NASDAQ:PHAT), a biopharmaceutical company focused on developing and commerciali

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) BEDMINSTER, N.J., Feb. 21, 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 its financial result

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

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 financial results for the quarter and year ended December 31, 2023. 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

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 - $470 million NEW YORK, Nov. 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

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 financial results for the quarter ended September 30, 2023. 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 arch

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 product sales guidance raised to $445 - $465 million NEW YORK, Aug. 03, 2023 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutic

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 financial results for the quarter ended June 30, 2023. 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 we

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 Announced robust positive results from Study 403 in patients with mixed features in major depressive disorder (MDD) and mixed features in bipolar depression NEW YORK, May 04, 2023 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutica

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 financial results for the quarter ended March 31, 2023. 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 web

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; p<0.0001; ES= 0.67) -bipolar depression with mixed features (5.7 point reduction v. placebo; p<0.0001; ES= 0.64) Lumateperone 42mg was statistically significant on the key secondary endpoint of the clinician's assessment of improvement in the overall severity on the G

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 01, 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 its financial results for the fourth qua

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 financial results for the quarter and year ended December 31, 2022. 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 an

NEW YORK, Oct. 27, 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 that it will host a conference call and live webcast discussion at 8:30 a.m. Eastern Time on Thursday, November 3, 2022, to provide a corporate update and discuss details of the Company's financial results for the quarter ended September 30, 2022. 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

NEW YORK, Aug. 02, 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 that it will host a conference call and live webcast discussion at 8:30 a.m. Eastern Time on Tuesday, August 9, 2022, to provide a corporate update and discuss details of the Company's financial results for the quarter ended June 30, 2022. To access the live conference call via phone, dial 1-(877) 407-8291. The international dial-in number is 1-(201) 689-8345. The live and archived webcast can be accessed under "Events & Presentations" in the Invest

NEW YORK, May 03, 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 that it will host a conference call and live webcast discussion at 8:30 a.m. Eastern Time on Tuesday, May 10, 2022, to provide a corporate update and discuss details of the Company's financial results for the quarter ended March 31, 2022. To access the live conference call via phone, dial 1-(844) 835-6563. The international dial-in number is 1-(970) 315-3916. The conference ID number for the live call is 9526447. The live and archived webcast can be

NEW YORK, Feb. 22, 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 that it will host a conference call and live webcast discussion at 8:30 a.m. Eastern Time on Tuesday, March 1, 2022, to provide a corporate update and discuss details of the Company's financial results for the quarter and year ended December 31, 2021. To access the live conference call via phone, dial 1-(844) 835-6563. The international dial-in number is 1-(970) 315-3916. The conference ID number for the live call is 5899935. The live and archived w

CAPLYTA supplemental new drug applications (sNDAs) for the treatment of bipolar depression are under review by the FDA, with a PDUFA target action date of December 17, 2021. Bipolar depression launch preparations are progressing well; sales force expansion is substantially complete. Total revenues were $22.2 million for the third quarter of 2021, compared to $7.4 million for the same period in the prior year, representing an increase of approximately 200%. CAPLYTA achieved net product revenues of $21.6 million for the third quarter of 2021. Third quarter CAPLYTA total prescriptions (TRx) increased 15% versus the previous quarter. Patient enrollment is ongoing in a pivot

NEW YORK, Nov. 02, 2021 (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 host a conference call and live webcast discussion at 8:30 a.m. Eastern Time on Tuesday, November 9, 2021, to provide a corporate update and discuss details of the Company's financial results for the quarter ended September 30, 2021. To access the live conference call via phone, dial 1-(844) 835-6563. The international dial-in number is 1-(970) 315-3916. The conference ID number for the live call is 3650108. The live and archived we

CAPLYTA supplemental new drug applications (sNDAs) for the treatment of bipolar depression are under review by the FDA, with a PDUFA target action date of December 17, 2021. Second quarter CAPLYTA total prescriptions (TRx) increased 22% versus the previous quarter. Total revenues for the second quarter were $20.0 million. CAPLYTA achieved net product revenues of $19.0 million for the second quarter. Patient enrollment in Study ‘501, a Phase 3 clinical trial evaluating lumateperone as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD), has commenced. NEW YORK, Aug. 09, 2021 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a bi

CAPLYTA supplemental new drug applications (sNDAs) for the treatment of bipolar depression in adults as both monotherapy and adjunctive treatment with lithium or valproate have been accepted for review by the FDA, with a PDUFA target action date of December 17, 2021. First quarter CAPLYTA total prescriptions (TRx) increased 23% versus the previous quarter. Total revenues for the first quarter were $15.9 million. CAPLYTA achieved net product revenues of $15.6 million for the first quarter. Introduced ITI-1284 ODT-SL, a deuterated form of lumateperone delivered sublingually as an orally disintegrating tablet. NEW YORK, May 10, 2021 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NA

Successfully launched CAPLYTA® (lumateperone) in late March 2020 and demonstrated strong commercial execution in the midst of COVID-19. CAPLYTA achieved net product revenues of $12.4 million and $22.5 million for fourth quarter and full year 2020, respectively. Fourth quarter CAPLYTA total prescriptions (TRx) increased 77% versus the previous quarter. Pursuing CAPLYTA label expansion including bipolar depression and major depressive disorder: Submitted CAPLYTA supplemental new drug applications (sNDAs) to the FDA for the treatment of bipolar depression in adults as both monotherapy and adjunctive treatment with lithium or valproate.   Initiated late-stage programs in adjunctive major dep