As the company began a rolling NDA submission to the U.S. FDA for its drug combo in low-grade serous ovarian cancer, Verastem Oncology Inc. popped the lid off phase I/II data in pancreatic tumors, but Wall Street seemed uncertain about the news. Boston-based Verastem disclosed upbeat outcomes from the Ramp 205 study testing the RAF/MEK clamp avutometinib when paired with focal adhesion kinase inhibitor defactinib in combination with gemcitabine plus nab-paclitaxel as first-line therapy for metastatic pancreatic cancer.
Volta Medical SAS reported positive results from the Tailored-AF study which compared its artificial intelligence software-guided ablation procedure in combination with pulmonary vein isolation to a conventional anatomical ablation targeting PVI alone, to treat persistent atrial fibrillation.
Boston Scientific Corp. is hoping to help change European guidelines on the use of intravascular imaging during percutaneous coronary intervention procedures, Emile Mehanna, medical affairs and medical education director, interventional cardiology, EMEA, told BioWorld.
Hørsholm, Denmark-based Contera Pharma A/S’ lead asset for levodopa-induced dyskinesia in Parkinson’s disease, JM-010, failed to meet its primary endpoint in the late-stage phase IIb Astoria trial. JM-010 is a novel drug formulation and 5-HT receptor modulator that combines existing medications of immediate-release buspirone and extended-release zolmitriptan.
Shares of Redwood City, Calif.-based Rezolute Inc., and Korean parent company Handok Inc., rose May 22 on positive results of a phase II proof-of-concept study for its investigative oral diabetic macular edema (DME) drug, RZ-402. RZ-402 is an oral small-molecule plasma kallikrein inhibitor designed to block vascular leakage and inflammation for treating chronic DME.
GSK plc’s interleukin-5 (IL-5) portfolio got boost as depemokimab, an ultra-long-acting biologic targeting IL-5, hit its endpoints in two phase III trials in severe asthma, setting up potential filings for the first therapy that could allow patients a six-month dosing schedule.
Elixir Medical Corp. reported positive 12-month clinical data from the Desyne BDS Plus randomized controlled trial which evaluated its Desyne BDS plus system, a triple drug-eluting coronary implant with site-specific antithrombotic therapeutic coating, against a contemporary, durable polymer drug-eluting stent in the treatment of de novo native coronary artery lesions.
Liquid biopsy typically means blood testing, but several companies presenting at Biomed Israel May 21-23 have developed diagnostics that look to other, even less invasive options, and ever broader applications. Nevia Bio Ltd. is using vaginal secretions to detect ovarian cancer, while Early OM Ltd. and Nucleix Ltd. analyze urine for cancer biomarkers.
With positive phase IIa data for ENV-101 in idiopathic pulmonary fibrosis (IPF) in hand, showing some lung damage was reversed, Endeavor Biomedicines Inc. said it’s ready to begin further phase II studies in the indication.
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