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Curis Reports Promising Results from AML Triplet Study with Emavusertib

Curis Reports Promising Results from AML Triplet Study with Emavusertib

Curis Reports Promising Results from AML Triplet Study with Emavusertib
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Pfizer's TUKYSA Extends Progression-Free Survival in HER2+ Metastatic Breast Cancer

Pfizer's TUKYSA Extends Progression-Free Survival in HER2+ Metastatic Breast Cancer

Pfizer Inc. has announced results from the Phase 3 HER2CLIMB-05 trial, demonstrating that the addition of TUKYSA (tucatinib) to first-line maintenance therapy extends median progression-free survival by over 8 months in patients with HER2-positive metastatic breast cancer. The trial showed a 35.9% reduction in the risk of disease progression or death when TUKYSA was combined with trastuzumab and pertuzumab, compared to the combination without TUKYSA. The median progression-free survival was 24.9 months in the TUKYSA arm versus 16.3 months in the placebo arm. The study also highlighted a manageable safety profile for the combination therapy.
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Lilly's next-gen drug tops Zepbound on weight loss in late-stage osteoarthritis trial

Lilly's next-gen drug tops Zepbound on weight loss in late-stage osteoarthritis trial

Dec 11 (Reuters) - Eli Lilly said on Thursday its next-generation obesity drug helped patients lose an average of 28.7% of their weight in a late-stage trial, outperforming its blockbuster drug Zepbound and reinforcing the company's lead in the fast-growing market.
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Zealand Pharma Unveils Ambitious Metabolic Frontier 2030 Strategy Targeting Multiple Drug Launches

Zealand Pharma Unveils Ambitious Metabolic Frontier 2030 Strategy Targeting Multiple Drug Launches

Zealand Pharma Unveils Ambitious Metabolic Frontier 2030 Strategy Targeting Multiple Drug Launches
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Celldex Initiates Phase 3 Trials for Barzolvolimab in Cold Urticaria and Symptomatic Dermographism

Celldex Initiates Phase 3 Trials for Barzolvolimab in Cold Urticaria and Symptomatic Dermographism

Celldex Therapeutics has launched a global phase 3 trial program for barzolvolimab, a monoclonal antibody targeting mast cell-driven diseases, specifically cold urticaria and symptomatic dermographism. This trial, named EMBARQ-ColdU and SD, aims to evaluate the efficacy of barzolvolimab in patients who have not responded adequately to antihistamine therapy. The study will enroll approximately 240 adults across 75 sites in seven countries, with participants divided into two cohorts based on their disease subtype. The trial will assess the drug's ability to achieve a complete response, defined as a negative provocation test at week 12, and will also evaluate symptomatic and functional improvements. Previous phase 2 studies showed promising results, with significant reductions in symptoms and a favorable safety profile.
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ReAlta Life Sciences Presents Promising Phase 2 Data on Pegtarazimod for Acute GvHD at ASH 2025

ReAlta Life Sciences Presents Promising Phase 2 Data on Pegtarazimod for Acute GvHD at ASH 2025

ReAlta Life Sciences, a clinical-stage biopharmaceutical company, has announced interim results from its Phase 2 clinical trial of pegtarazimod (RLS-0071) for treating steroid-refractory acute graft-versus-host disease (aGvHD). The data, presented at the 67th American Society of Hematology (ASH) Annual Meeting, highlight significant clinical improvements in patients with lower gastrointestinal aGvHD. The study, which is an open-label, prospective, dose-escalation trial, showed that all six patients in the treatment optimization cohort experienced clinical improvement, with a median 68% reduction in plasma myeloperoxidase levels, indicating modulation of inflammatory mechanisms. The safety profile was favorable, with no dose-limiting toxicities or serious adverse events attributed to the drug.
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PureTech Advances Deupirfenidone for Idiopathic Pulmonary Fibrosis with FDA Support

PureTech Advances Deupirfenidone for Idiopathic Pulmonary Fibrosis with FDA Support

PureTech Health has successfully completed an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) regarding its drug candidate deupirfenidone (LYT-100) for the treatment of idiopathic pulmonary fibrosis (IPF). The FDA's feedback supports the advancement of deupirfenidone into a pivotal Phase 3 trial, which is set to begin in the first half of 2026. Deupirfenidone is being developed by Celea Therapeutics, a PureTech Founded Entity, and aims to become a new standard of care for IPF, a progressive and fatal lung disease. The Phase 3 SURPASS-IPF trial will compare deupirfenidone to pirfenidone, an existing FDA-approved therapy, to assess its efficacy and safety.
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Amylyx Pharmaceuticals Reports Positive Safety Data for ALS Drug AMX0114 in Early Human Trials

Amylyx Pharmaceuticals Reports Positive Safety Data for ALS Drug AMX0114 in Early Human Trials

Amylyx Pharmaceuticals has announced promising safety and tolerability data from its Phase 1 LUMINA trial of AMX0114, an investigational treatment for amyotrophic lateral sclerosis (ALS). The trial, which is the first human study of AMX0114, showed that the drug was generally well-tolerated with no treatment-related serious adverse events. The company plans to begin enrolling the second cohort of participants in Canada and the U.S. early next year. AMX0114 targets calpain-2, a protease involved in axonal degeneration, a key factor in ALS progression.
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Star Therapeutics Shows Promising Results for VGA039 in Von Willebrand Disease

Star Therapeutics Shows Promising Results for VGA039 in Von Willebrand Disease

Star Therapeutics has presented interim data from its Phase 1/2 multidose study of VGA039, a monoclonal antibody therapy for von Willebrand disease (VWD), at the American Society of Hematology Annual Meeting. The study demonstrated substantial reductions in bleeding rates across all types of VWD and bleeds, including in patients switching from prior intravenous prophylaxis. VGA039, administered subcutaneously once monthly, showed a favorable safety profile and significant efficacy, with bleed reductions ranging from 73% to 100%. The therapy targets Protein S, promoting platelet attachment and enhancing fibrin deposition to restore hemostasis. The promising results support the ongoing pivotal Phase 3 trial of VGA039.
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Biogen and Stoke Therapeutics Report Promising Results for Epilepsy Drug Zorevunersen

Biogen and Stoke Therapeutics Report Promising Results for Epilepsy Drug Zorevunersen

Biogen and Stoke Therapeutics have announced promising results from their investigational drug zorevunersen, which is being developed for the treatment of Dravet syndrome, a rare form of epilepsy. The companies presented data at the American Epilepsy Society meeting, showing that patients treated with zorevunersen experienced a significant reduction in major motor seizures. Specifically, a study revealed an 82% drop in seizures among patients receiving the drug, compared to a 20% reduction in a control group. The treatment also showed improvements in cognitive and behavioral measures. These findings suggest that zorevunersen could become a blockbuster drug, with potential regulatory activity expected next year.
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US FDA qualifies first AI tool to help speed liver disease drug development

US FDA qualifies first AI tool to help speed liver disease drug development

Dec 8 (Reuters) - The U.S. Food and Drug Administration has qualified the first artificial intelligence tool designed to help doctors assess a severe form of fatty liver disease in drug trials, the agency said on Monday.
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Gallop Oncology Reports Promising Phase 1b Trial Results for LYT-200 in AML and MDS Patients

Gallop Oncology Reports Promising Phase 1b Trial Results for LYT-200 in AML and MDS Patients

Gallop Oncology, a company founded by PureTech Health, has announced positive initial results from a Phase 1b clinical trial of LYT-200, a monoclonal antibody, in patients with relapsed/refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). The trial demonstrated favorable tolerability and strong efficacy, with an initial median overall survival of 13.2 months in the combination cohort, significantly exceeding the expected survival of less than 2.5 months in similar settings. The trial included patients with high-risk mutations, indicating potential broad applicability of LYT-200. The findings support the advancement of LYT-200 into a potentially registrational Phase 2 trial, with further details to be shared at the upcoming American Society of Hematology Annual Meeting.