Intra-Cellular Therapies
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- Public
- Established
- 2002-01-01
- Employees
- 610
- Market Cap
- $7.8B
- Introduction
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.
Leap Therapeutics Halves Workforce and Refocuses Cancer Drug Development Amid Market Challenges
• Leap Therapeutics has announced a significant restructuring, reducing its workforce by approximately 50% and narrowing the development focus of its lead cancer drug candidate in response to challenging market conditions.
• The strategic pivot aims to extend the company's cash runway while concentrating resources on the most promising clinical applications of its lead oncology asset, potentially improving its chances for regulatory success.
• This move follows similar restructuring trends across the biotech sector, with companies like Arcturus, NGM Bio, and Erasca all recently announcing staff reductions and pipeline reprioritizations to navigate the difficult funding environment.
Merck KGaA to Acquire SpringWorks Therapeutics in $3.9 Billion Deal for Rare Disease Portfolio
• German pharmaceutical giant Merck KGaA has agreed to acquire Connecticut-based SpringWorks Therapeutics for $3.9 billion, paying $47 per share in cash, representing a 26% premium over SpringWorks' unaffected 20-day average price.
• The acquisition gives Merck KGaA immediate access to SpringWorks' two FDA-approved rare disease treatments: Ogsiveo for desmoid tumors and Gomekli for neurofibromatosis type 1-related tumors.
• The transaction, expected to close in the second half of 2025 pending regulatory approvals, aligns with Merck KGaA's strategic expansion in the U.S. market and is projected to contribute to earnings by 2027.
J&J Raises 2025 Sales Forecast Despite $400M Tariff Impact Following Intra-Cellular Acquisition
• Johnson & Johnson has increased its 2025 sales forecast by $700 million to $92 billion following the $14.6 billion acquisition of Intra-Cellular Therapies and its antipsychotic drug Caplyta.
• The company expects a $400 million hit from tariffs while simultaneously lowering its adjusted operational EPS growth projection from 8.7% to 6.2% due to acquisition-related dilution.
• J&J secured key regulatory approvals in Q1 2025, including FDA clearance for Tremfya to treat Crohn's disease and European Commission approval for Rybrevant for specific lung cancer indications.
Newron Pharmaceuticals Advances Pivotal Phase III Program for Treatment-Resistant Schizophrenia
• Newron Pharmaceuticals has received regulatory approval for its ENIGMA-TRS Phase III program evaluating Evenamide as an add-on therapy for treatment-resistant schizophrenia, with patient recruitment beginning immediately.
• The pivotal program consists of two studies designed to meet requirements for marketing authorization in major markets including the USA and Europe, with results expected by late 2026.
• Evenamide, a first-in-class glutamate modulator, has shown promising results in earlier trials with 70% of TRS patients experiencing clinically significant benefits and 25% achieving remission during one-year treatment.
Reviva to Present Long-Term Phase 3 Data for Brilaroxazine in Schizophrenia at SIRS Congress
• Reviva Pharmaceuticals will present topline data from the 52-week open-label extension portion of their Phase 3 RECOVER study evaluating brilaroxazine in schizophrenia at the 2025 SIRS Congress in Chicago.
• The presentation, scheduled for March 30th, will focus on the long-term efficacy and safety profile of brilaroxazine in stable schizophrenia patients over a 12-month period.
• Brilaroxazine (RP5063) is a novel chemical entity discovered in-house by Reviva, which is developing therapies for central nervous system, inflammatory, and cardiometabolic diseases.
Bipolar Depression Market Set to Grow Through 2034 with New Therapies in Pipeline
• The global bipolar depression market is projected to experience significant growth through 2034, driven by increasing prevalence, with the United States accounting for approximately 85% of the market share across major regions.
• Several pharmaceutical companies including NeuroRx, COMPASS Pathways, and Intra-Cellular Therapies are advancing novel treatments, with Johnson & Johnson's recent $14.6 billion acquisition of Intra-Cellular Therapies highlighting industry confidence in the sector.
• Among current therapies, CAPLYTA (lumateperone) is expected to achieve the highest market share by 2034, while emerging treatments like NRX-100/101 and COMP 360 (psilocybin) show promise for addressing unmet needs in bipolar depression management.
Beam Therapeutics Reports Breakthrough in Alpha-1 Antitrypsin Deficiency Treatment with BEAM-302 Base Editing Therapy
• Beam Therapeutics' BEAM-302 demonstrated the first-ever clinical genetic correction of the disease-causing PiZ mutation in Alpha-1 Antitrypsin Deficiency patients, with a single dose producing durable increases in functional AAT protein.
• The highest dose level (60mg) achieved mean total AAT of 12.4μM, exceeding the protective therapeutic threshold of 11μM, while reducing harmful mutant Z-AAT by up to 78% in circulation.
• BEAM-302 showed a favorable safety profile with no serious adverse events across all dose levels, supporting continued dose escalation with updated data expected in the second half of 2025.
J&J Discontinues Depression Trials for Aticaprant After Insufficient Efficacy Results
• Johnson & Johnson has terminated Phase III VENTURA trials for aticaprant as an add-on therapy for major depressive disorder due to insufficient efficacy, despite previous projections of $1-5 billion in peak annual sales.
• The setback impacts J&J's goal of becoming the top neuroscience company by 2030, though the company remains committed to exploring aticaprant's potential in other therapeutic areas with high unmet needs.
• The failure raises doubts about kappa opioid receptor antagonists in depression treatment, affecting other companies like Neumora Therapeutics, whose similar drug navacaprant also failed in Phase III trials earlier this year.
Novo Nordisk Launches Home Delivery Service for Wegovy at $499 Monthly for Cash-Paying Patients
• Novo Nordisk introduces NovoCare Pharmacy, a direct-to-patient delivery service offering all Wegovy dose strengths at $499 per month for cash-paying and eligible commercially insured patients without coverage.
• The launch comes as Wegovy supply stabilizes, with FDA confirming Novo Nordisk can now meet market demand following previous shortages that limited new prescriptions since 2022.
• Currently, over 55 million Americans have coverage for weight management medicines, with 90% of insured Wegovy patients paying $0-$25 monthly for their prescriptions.
Axsome Therapeutics Reports Strong Growth with 88% Revenue Increase in 2024, Advances CNS Pipeline
• Axsome Therapeutics achieved remarkable financial performance in 2024, with total net product revenue reaching $385.7 million, representing an 88% year-over-year growth driven by strong Auvelity and Sunosi sales.
• The company secured FDA approval for Symbravo for acute migraine treatment in adults and successfully completed Phase 3 trials for AXS-05 in Alzheimer's disease agitation, with NDA submission planned for late 2025.
• Multiple late-stage clinical programs are advancing, including trials for solriamfetol in ADHD and depression, with key data readouts expected in Q1 2025.
IDEAYA Biosciences Reports Strong Pipeline Progress and $1.1B Cash Position for 2024
• IDEAYA Biosciences advances multiple oncology programs, with over 230 patients enrolled in potential registration-enabling trial for darovasertib in metastatic uveal melanoma, targeting key readouts by end of 2025.
• Company strengthens its position with approximately $1.1 billion cash reserve as of December 2024, expected to fund operations into at least 2028.
• Pipeline expansion includes progress on DLL3 TOP1i ADC IDE849 showing 73% response rate in early SCLC data, and advancement of three new candidates targeting solid tumors.
J&J Boosts Neuroscience Pipeline with ITCI Acquisition, FDA Approves Spravato Monotherapy for TRD
• Johnson & Johnson (J&J) is set to acquire Intra-Cellular Therapies (ITCI) for $14.6 billion, adding Caplyta for bipolar disorder and schizophrenia to its neuroscience pipeline.
• The FDA has approved J&J's Spravato as a monotherapy for treatment-resistant depression (TRD), based on positive data from the phase IV TRD4005 study.
• AstraZeneca and Daiichi Sankyo's datopotamab deruxtecan (Dato-DXd) received FDA priority review for a lung cancer indication and was approved for previously treated breast cancer.
FDA Approvals and Clinical Trials: A Look into the Latest Pharmaceutical Developments
The pharmaceutical sector has seen significant advancements with FDA approvals for new treatments and the initiation of clinical trials for innovative therapies. Notably, Eli Lilly's Omvoh has been approved for Crohn's disease, and Johnson & Johnson is advancing its TAR-200 for bladder cancer treatment. These developments underscore the industry's commitment to addressing unmet medical needs through research and innovation.
J&J Seeks FDA Approval for TAR-200 in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
• Johnson & Johnson has initiated a New Drug Application (NDA) submission to the FDA for TAR-200.
• TAR-200 is intended for patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC).
• Phase 2b SunRISe-1 study data showed an 83.5% complete response rate with TAR-200 monotherapy.
• The FDA is reviewing the application under the Real-Time Oncology Review (RTOR) program to expedite potential approval.
Johnson & Johnson to Acquire Intra-Cellular Therapies for $14.6 Billion, Bolstering Neuroscience Portfolio
• Johnson & Johnson (J&J) will acquire Intra-Cellular Therapies for $14.6 billion, gaining access to Caplyta and a pipeline of CNS disorder treatments.
• Caplyta, approved for schizophrenia and bipolar depression, has a supplemental NDA under FDA review for major depressive disorder (MDD) as adjunctive therapy.
• The acquisition includes ITI-1284, a Phase II asset targeting generalized anxiety disorder (GAD) and Alzheimer's-related psychosis, expanding J&J's pipeline.
• The deal is expected to close in late 2025, pending regulatory approval, and aims to strengthen J&J's position in neuropsychiatric and neurodegenerative disorders.
Summit's Ivonescimab Emerges as Potential Keytruda Challenger in Major Cancer Treatment Breakthrough
• Summit Therapeutics' ivonescimab demonstrated superior performance against Merck's Keytruda in clinical trials, marking a significant advancement in cancer immunotherapy development.
• The dual-targeting PD-1 and VEGF antibody has initiated multiple Phase 3 trials, including a crucial survival study against Keytruda, positioning Summit as a leader in this emerging therapeutic approach.
• The breakthrough has sparked increased industry interest in similar dual-targeting approaches, with major players like Merck shifting their stance and entering the competitive landscape.
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