Alzamend Neuro partners with Massachusetts General Hospital for a Phase II clinical trial of AL001
- Alzamend Neuro collaborates with Massachusetts General Hospital for a Phase II clinical trial of AL001 for major depressive disorder (MDD).
- The trial aims to compare brain lithium levels from AL001 to those from commonly marketed lithium salts.
- The study will help determine the minimum effective dose of AL001 and aims to meet FDA safety standards through the Section 505(b)(2) pathway.
- Alzamend previously completed a Phase IIA trial identifying a maximum tolerated dose for AL001, designed to avoid the need for therapeutic drug monitoring.
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Amylyx Pharmaceuticals publishes data on AMX0035 effects on Alzheimer's biomarkers
- Amylyx Pharmaceuticals announced exploratory analyses from the Phase 2 PEGASUS trial on cerebrospinal fluid (CSF) biomarkers in Alzheimer's disease (AD).
- AMX0035 treatment showed consistent changes in AD and neurodegeneration CSF biomarkers, including reductions in p-tau181, total tau, neurogranin, and FABP3.
- The trial involved 95 participants, with 67 providing CSF samples at baseline and Week 24.
- The ORION trial is ongoing to assess AMX0035 in progressive supranuclear palsy (PSP).
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Neuronetics and Greenbrook TMS announce definitive agreement to merge
- Neuronetics will acquire all outstanding common shares of Greenbrook in an all-stock transaction.
- The merger aims to increase brand awareness for NeuroStar TMS and improve operational efficiencies.
- The combined company expects to achieve $15 million in annualized cost savings and become EBITDA positive by 2025.
- The transaction is expected to close in Q4 2024, pending shareholder and court approvals.
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Praxis Precision Medicines provides corporate update and reports second quarter 2024 financial results
- Up to four programs in registrational phase by 2025.
- Planned interim analysis for ulixacaltamide Essential3 Study 1 in Q4 2024.
- Topline results for Phase 2 EMBOLD study of relutrigine in SCN2A and SCN8A DEEs expected in Q3 2024.
- PRAX-628 Phase 2/3 POWER1 study to initiate in Q4 2024.
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MindMed reports second quarter 2024 financial results and business updates
- MindMed announced its financial results for Q2 2024, with a cash balance of $243.1 million as of June 30, 2024.
- The company completed an underwriting offering of common shares and pre-funded warrants, raising $75 million in gross proceeds.
- MindMed plans to initiate Phase 3 trials for MM120 ODT in GAD and MDD, with the first trial starting in the second half of 2024.
- The company extended its intellectual property protection for MM120 ODT through 2041 with a new patent issued by the USPTO.
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