Intra-Cellular Therapies, Inc. operates as a biopharmaceutical company. It focuses on the discovery and clinical development of small molecule drugs that address underserved medical needs in neuropsychiatric and neurological disorders by targeting intracellular signaling mechanisms within the central nervous system, or CNS. The firm’s lead product candidate, ITI-007, is in clinical development as a first-in-class treatment for schizophrenia. It also includes pre-clinical programs that are focused on advancing drug candidates for the treatment of cognitive dysfunction, in both schizophrenia and Alzheimer's disease and for disease modification and the treatment of neurodegenerative disorders, including Alzheimer's disease. The company was founded by Paul Greengard and Sharon Mates in 2002 and is headquartered in New York, NY.
相关临床试验
67
20 进行中
药物批准
2
批准总数
监管机构
1
监管机构数
成立时间
2002
进行中（未招募）
15
22.4%
已完成
29
43.3%
尚未招募
5
7.5%
招募中
17
25.4%
终止
1
1.5%
- Post hoc analysis of the phase 3 Study 502 found adjunctive lumateperone 42 mg improved CSFQ-14 total scores versus placebo plus antidepressant therapy in MDD patients. - At baseline, 82.5% of the 480 randomized patients met criteria for sexual dysfunction, and more than a quarter regained normal sexual function by Day 43. - Women showed statistically significant and clinically meaningful improvements, while men had numerical but non-significant gains that did not reach clinical meaningfulness. - Mediation analysis suggested roughly 66.2% of the sexual function benefit was mediated through improvements in depressive symptoms measured by MADRS.
- Boehringer Ingelheim declined to exercise its exclusive licensing option for Nxera Pharma's GPR52 agonist program, including Phase 2-ready lead compound NXE0048149 for schizophrenia treatment. - Phase 1 trials demonstrated NXE0048149's favorable safety profile with no severe adverse events and evidence of brain circuitry engagement relevant to treating all three symptom domains of schizophrenia. - Nxera plans to explore strategic partnerships with major pharmaceutical or neuroscience companies in 2026, as the schizophrenia drug market is forecast to reach $12.9 billion by 2030. - The GPR52 agonist represents a potential first-in-class approach that could address positive, negative, and cognitive symptoms of schizophrenia, unlike current therapies that only treat positive symptoms.
- Johnson & Johnson leads 2025 M&A activity with a $14.6 billion acquisition of Intra-Cellular Therapies, targeting mental health treatments including depression and schizophrenia drug Caplyta. - Novartis strengthens its neuroscience portfolio through a $12 billion purchase of Avidity Biosciences, gaining access to RNA treatments for rare neuromuscular conditions like Duchenne muscular dystrophy. - Pfizer secures its position in the competitive weight loss market with a $10 billion acquisition of Metsera after winning a bidding war against Novo Nordisk. - The strategic focus on neuroscience reflects Big Pharma's renewed confidence in the therapeutic area after years of retreat due to mixed clinical results.
- Johnson & Johnson announced the acquisition of Halda Therapeutics for $3.05 billion in cash to expand its oncology portfolio with oral, targeted therapies for solid tumors. - Halda's lead drug candidate targets metastatic prostate cancer with a precision approach designed to overcome common treatment resistance mechanisms. - The acquisition addresses J&J's urgent need to renew its drug pipeline as it faces patent expiration for immunology drug Stelara and increased competition in oncology markets. - Prostate cancer represents a significant market opportunity, with new diagnoses expected to reach 1.7 million globally by 2030.
- Johnson & Johnson announced the acquisition of Halda Therapeutics for $3.05 billion in cash to enhance its oncology portfolio with novel oral cancer therapies. - Halda's lead candidate HLD-0915 is a once-daily oral therapy for prostate cancer that received FDA fast track designation and showed encouraging preliminary anti-tumor activity in Phase I/II trials. - The acquisition brings Halda's proprietary RIPTAC platform technology, designed to selectively kill cancer cells while sparing healthy tissue and overcome treatment resistance mechanisms. - This strategic move supports J&J's ambitious goal of reaching $50 billion in oncology sales by 2030, following their previous $14.6 billion acquisition of Intra-Cellular Therapies.
- Johnson & Johnson is reportedly considering a complete acquisition of partner Protagonist Therapeutics, following years of successful collaboration on the first-in-class oral peptide icotrokinra for immune-mediated diseases. - Icotrokinra has demonstrated clinical superiority over competitor deucravacitinib in head-to-head trials and was recently submitted to the FDA for plaque psoriasis approval, with positive data also emerging in ulcerative colitis. - The potential acquisition exemplifies J&J's disciplined "partner, validate, acquire" M&A strategy, which has already delivered significant returns through recent deals including Abiomed, Shockwave Medical, and Intra-Cellular Therapies. - J&J's strategic portfolio reshaping, including the 2023 Kenvue spinoff and planned orthopedics separation, has generated approximately $14 billion in free cash flow in the first three quarters of 2025 to fuel acquisition activities.
- Johnson & Johnson CEO Joaquin Duato confirmed during the company's third-quarter earnings call that no drug pricing agreement has been finalized with the White House, despite ongoing discussions since the administration began. - The healthcare giant has not secured a Most Favored Nation drug pricing deal like competitors Pfizer and AstraZeneca, who received reprieve from threatened pharmaceutical tariffs through their agreements. - J&J reported strong third-quarter pharmaceutical performance with $15.6 billion in revenue, led by multiple myeloma drug Darzalex generating $3.7 billion worldwide sales with nearly 22% growth. - The company announced plans to spin out its orthopedics unit DePuy Synthes as a standalone company by 2027, following an 18-24 month process to separate the $9.2 billion revenue division.
- Johnson & Johnson is reportedly in discussions to acquire Protagonist Therapeutics, sending PTGX shares soaring over 30% on Friday despite no confirmed deal details. - The potential acquisition follows positive Phase IIb trial results for Icotrokinra, showing 30.2% clinical remission in ulcerative colitis patients versus 11.1% placebo response. - Icotrokinra will advance to Phase III trials targeting moderate-to-severe active ulcerative colitis in adults and adolescents, with completion expected by 2028. - The move represents Johnson & Johnson's continued strategic expansion through biotech acquisitions, following its $14.6 billion purchase of Intra-Cellular Therapies earlier this year.
- The biopharmaceutical sector experienced a significant surge in high-value acquisitions during Q3 2025, with four of the year's five largest deals occurring in the past four months. - Major transactions totaled approximately $55.7 billion in Q3, including Merck's $10 billion acquisition of Verona and Genmab's $8 billion bid for bispecific antibody specialist Merus. - The number of deals increased from 15 in Q1 to 21 in Q3, with analysts attributing the surge to lowered interest rates and companies seeking to replace revenue losses from patent expirations.
- Lumateperone 42 mg as adjunctive therapy demonstrated significant improvement in depression symptoms versus placebo in a phase 3 trial of 485 patients with major depressive disorder and inadequate antidepressant response. - The study met both primary and secondary endpoints, showing a 4.9-point greater reduction in MADRS depression scores and significant improvements in clinician-rated severity and patient-reported outcomes at day 43. - Treatment was generally well-tolerated with minimal extrapyramidal symptoms, no clinically significant weight gain or metabolic effects, and lower emergence of suicidal ideation compared to placebo. - Results support lumateperone's potential as a new treatment option for the approximately 50% of MDD patients who experience inadequate response to standard antidepressant therapy.
