Bio-Path Holdings, Inc. (BPTH) stock is experiencing a significant surge today, driven by the company’s announcement of a therapeutic program for treating obesity and related metabolic diseases using its DNAbilize technology. Additionally, the company provided positive updates on its ongoing clinical trials for both leukemia and solid tumor treatments.
Results for: Clinical Trials
The global breast cancer treatment landscape is evolving rapidly, with over 100 pharmaceutical companies actively developing new therapies to combat this prevalent disease. DelveInsight’s ‘Breast Cancer Pipeline Insight 2024’ report highlights the robust pipeline, featuring 120+ potential breast cancer drugs in various stages of clinical development. This report provides a comprehensive overview of the latest advancements, key players, and promising therapies on the horizon.
Roche Holdings AG, a pharmaceutical giant, has outlined a new strategy to accelerate drug development, focusing on five priority areas: neurology, oncology and hematology, immunology, ophthalmology, and cardiovascular, renal, and metabolism diseases. The company is prioritizing select assets with ‘exceptional potential’ and plans to fast-track clinical trials and expand into new indications. Roche also highlighted its ambitions in the obesity space, expecting its obesity drug candidates to generate over 3 billion Swiss francs in annual sales.
Vivani Medical, Inc. (VANI) has received regulatory approval to begin human clinical trials for its innovative miniature, subdermal GLP-1 (exenatide) implant in Australia. This first-in-human trial, dubbed LIBERATE-1, will assess the safety, tolerability, and pharmacokinetic profile of the implant in obese and overweight individuals. The trial is expected to commence in the fourth quarter of 2024 and is anticipated to yield data in 2025.
Windtree Therapeutics announced positive topline results from its Phase 2b SEISMiC Extension Study of istaroxime for patients with early cardiogenic shock. The study demonstrated significant improvement in systolic blood pressure and other key parameters, highlighting istaroxime’s potential as a treatment for this critical condition.
The renal cancer treatment landscape is evolving rapidly, with over 75 pipeline therapies in development by major pharmaceutical companies. This report analyzes the current state of the renal cancer pipeline, highlighting key companies, promising therapies, and recent advancements in clinical trials.
Cassava Sciences has announced that its Alzheimer’s drug candidate, simufilam, has successfully passed an interim safety review, allowing its ongoing Phase 3 trials to continue without changes. The Data and Safety Monitoring Board (DSMB) reviewed patient safety data from the trials and recommended no modifications. Simufilam is a novel oral drug designed to treat Alzheimer’s disease. The two Phase 3 trials, fully enrolled with over 1,900 patients, are expected to yield top-line results by the end of 2024 and mid-2025.
Achilles Therapeutics, a biotechnology company focusing on cancer treatment, announced a strategic shift away from its TIL-based cNeT program. This decision led to the discontinuation of ongoing Phase I/IIa clinical trials and a surge in the company’s share price. The company will now focus on collaborations with third parties developing alternative modalities for targeting clonal neoantigens in cancer treatment.
Edgewise Therapeutics announced positive topline data from its Phase 1 and 2 trials of EDG-7500 for obstructive hypertrophic cardiomyopathy (HCM). The drug demonstrated significant reductions in left ventricular outflow tract pressure gradient (LVOT-G) and NT-proBNP levels, a key biomarker for heart failure, with a favorable safety profile.
Nuvalent, Inc. (NUVL) presented positive data from its Phase 1/2 trials of zidesamtinib (ARROS-1) and NVL-655 (ALKOVE-1) at the European Society for Medical Oncology (ESMO) Congress 2024. The data showcased significant response rates and durable responses in heavily pretreated patients with advanced ROS1-positive and ALK-positive non-small cell lung cancer (NSCLC) and other solid tumors. Nuvalent plans to initiate a Phase 3 study for ALK-positive NSCLC in the first half of 2025.