Clinical Trial News

FDA approves Zepbound for treating moderate-to-severe obstructive sleep apnea and obesity. Trials show Zepbound reduces breathing disruptions and aids weight loss, but side effects include digestive issues and potential thyroid tumors.

The OPERA trial's 5-year findings support contact X-ray brachytherapy (CXB) boost for organ preservation in early rectal adenocarcinoma, with higher rates in tumors <3 cm. Group B (CXB boost) showed better organ preservation and clinical response rates vs. Group A (EBRT boost). No significant OS differences, but higher DSS in Group B. Tumor size <3 cm significantly correlated with better organ preservation.

FDA granted orphan drug designation to VGT-1849A, a selective ASO-based JAK2 inhibitor for treating polycythemia vera (PV). PV, a rare hematologic malignancy, affects 1 in 2000 individuals in the US and is caused by a JAK2 V617F mutation. VGT-1849A aims to reduce JAK2 activity, potentially offering targeted efficacy and improved safety over current JAK2 inhibitors.

Novo Nordisk's CagriSema, an obesity therapy, showed a 20.4% weight reduction in REDEFINE 1 study, falling short of the expected 25%. Despite data suggesting a 22.7% reduction assuming full adherence, shares fell 20.7% due to concerns over side effects and performance compared to Eli Lilly's Zepbound. Future trials and regulatory filings for CagriSema are anticipated.

BioGenCell receives FDA Fast Track Designation for BGC101, a personalized cell therapy for severe Critical Limb Threatening Ischemia (CLTI), using its TRACT platform to regenerate damaged tissue.

The FDA granted fast track designation to LimmaTech's LBT-SA7 vaccine candidate, designed to prevent skin and soft tissue infections caused by Staphylococcus aureus. The vaccine aims to neutralize toxins from the bacteria, addressing rising antibiotic resistance. A phase 1 clinical trial will assess its safety and immunogenicity, with results expected in 2025.

Vivani Medical (VANI) received a Buy rating from Maxim Group's Naz Rahman, who cited the company's innovative NanoPortal drug delivery platform and potential in the GLP-1 and obesity treatment market. The Phase 1 LIBERATE-1 study in Australia aims to assess the safety and effectiveness of the NPM-115 implant, with results expected in mid-2025. H.C. Wainwright also reiterated a Buy rating with a $3.00 price target. Corporate insider sentiment is positive.

Novo Nordisk's CagriSema trial disappoints, causing $125B market value drop. Competition in weight-loss drug market intensifies with generic versions emerging. FDA approval of Vertex Pharma's cystic fibrosis treatment highlights pharmaceutical innovation.

Bleichmar Fonti & Auld LLP investigates BioAge Labs, Inc. for potential securities law violations. BioAge discontinued its Phase 2 trial for azelaprag due to safety concerns, causing a 76% stock decline. Investors may have legal options.

Palbociclib + standard therapy improved progression-free survival in hormone receptor–positive, HER2-positive metastatic breast cancer. No significant overall survival benefit observed among CDK4/6 inhibitor combinations in hormone receptor-positive/HER2-negative breast cancer. Patritumab deruxtecan showed similar efficacy to multiagent chemotherapy in high-risk hormone receptor-positive, HER2-negative breast cancer. Ciltacabtagene autoleucel achieved 100% complete response in high-risk smoldering multiple myeloma. Selinexor + ruxolitinib showed efficacy in myelofibrosis patients previously treated with ruxolitinib.