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.
Lantern Pharma Reports Strong Clinical Results and AI Platform Advancements in 2024 Year-End Update
• Lantern Pharma's HARMONIC trial for LP-300 demonstrated an impressive 86% clinical benefit rate and 43% objective response rate in never-smoker NSCLC patients, with enrollment expanding in Japan and Taiwan where never-smokers represent up to 40% of NSCLC cases.
• LP-184 received FDA Fast Track Designations for both Glioblastoma and Triple Negative Breast Cancer in 2024, plus three additional Rare Pediatric Disease Designations, advancing through Phase 1a trials with early signs of clinical activity at higher dose levels.
• The company's proprietary RADR® AI platform surpassed 100 billion oncology-specific data points in 2024, powering precision medicine initiatives and reducing development timelines by 30-50% compared to traditional approaches.
B-Cell Lymphoma Pipeline Expands with 300+ Therapies in Development for 2025
• DelveInsight's latest report reveals a robust B-cell lymphoma pipeline with over 295 companies developing 300+ therapies, highlighting significant industry investment in this area.
• Several major pharmaceutical companies including BeiGene, Celgene, Hoffmann-La Roche, and Allogene Therapeutics have initiated pivotal late-stage clinical trials for novel B-cell lymphoma treatments in March 2025.
• Emerging therapies include CAR-T cell approaches, bispecific antibodies, and novel targeted agents, with many incorporating dual-targeting mechanisms to overcome resistance seen with single-target therapies.
Brain Hemorrhage Treatment Market Expected to Grow Significantly by 2032 as AI Solutions Gain FDA Approval
• The brain hemorrhage treatment market is projected to experience substantial growth through 2032, driven by an aging population and increasing prevalence of risk factors such as hypertension and traumatic brain injuries.
• Recent FDA approvals for AI-based diagnostic tools, including JLK-LVO and Heuron ICH, mark significant advancements in early detection and treatment of brain hemorrhages.
• Several pharmaceutical companies including Baxter, Pfizer, and Novartis are developing promising pipeline therapies such as tissue plasminogen activator, alteplase, and BAF312 to address the significant unmet needs in brain hemorrhage treatment.
Lantern Pharma's LP-184 Receives FDA Fast Track Designation for Triple-Negative Breast Cancer
• Lantern Pharma's LP-184 has been granted Fast Track designation by the FDA for treating triple-negative breast cancer, marking its second such designation in 2024.
• The drug is currently undergoing a Phase 1A clinical trial to assess its safety and tolerability across various solid tumors, including triple-negative breast cancer.
• LP-184 previously received Fast Track designation for glioblastoma in October, highlighting its potential in addressing multiple aggressive cancers.
• Lantern Pharma's stock experienced a rise following the announcement, reflecting investor optimism about the drug's development and potential market impact.
LP-184 Receives FDA Fast Track Designation for Triple Negative Breast Cancer
• The FDA granted Fast Track Designation to Lantern Pharma's LP-184 for treating Triple Negative Breast Cancer (TNBC), marking its second Fast Track Designation in 2024.
• LP-184 is currently in Phase 1A clinical trial, assessing its safety and tolerability across various solid tumors, including TNBC, with potential to sensitize tumors non-responsive to checkpoint inhibitors.
• Preclinical data demonstrates LP-184's efficacy in TNBC models, including those resistant to PARP inhibitors, showing complete tumor regression in tested models.
• TNBC affects approximately 29,000 individuals annually in the U.S., with over 50% experiencing relapse within 3-5 years, highlighting the need for novel therapies like LP-184.
Lantern Pharma Expands LP-300 Trial to Taiwan for Never-Smoker NSCLC
• Lantern Pharma has dosed the first patient in Taiwan for its Phase 2 HARMONIC trial, evaluating LP-300 in never-smoker NSCLC patients.
• The trial expansion into Taiwan is significant due to the high proportion of never-smoker lung cancer cases in the region, over 50% of new diagnoses.
• Preliminary results from the trial's safety lead-in cohort showed an 86% clinical benefit rate and a 43% objective response rate.
• The HARMONIC trial is evaluating LP-300 in combination with carboplatin and pemetrexed for patients who have progressed after TKI treatment.
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