TORONTO – Opsens Inc. has successfully treated 20 patients in the first-in-human study employing a new surgical guidewire to improve procedural workflow during transcatheter aortic valve replacement (TAVR). According to Opsens CEO Louis Laflamme, the Savvywire will be the first guidewire to deliver a valvular prosthesis while allowing continuous hemodynamic pressure measurement during the procedure.
PERTH, Australia – Stem cell therapy company Mesoblast Ltd. provided new subgroup analyses from its phase III advanced chronic heart failure trial showing a greater treatment benefit from rexlemestrocel-L in high-risk patients with chronic heart failure and low ejection fraction (HFrEF) with diabetes or ischemia. The company had reported in December 2020 that the allogeneic mesenchymal cell therapy failed to meet the primary endpoint of a reduction in hospitalizations in its DREAM-HF phase III trial.
There is now more clarity on the Omicron variant of SARS-CoV-2, as serum antibodies produced by three doses of the Pfizer Inc.-Biontech SE COVID-19 vaccine have been shown to neutralize it. The data arrived a day after Glaxosmithkline plc and Vir Biotechnology Inc. said the monoclonal antibody sotrovimab retains activity against key mutations of the Omicron variant, including those found in sotrovimab’s binding site.
Prelude Corp. (dba Preludedx) reported positive results from the SweDCIS randomized trial showing its DCISionrt test predicts radiation benefit for lowering 10-year local invasive breast cancer risk. The prognostic, artificial intelligence (AI)-based tool assesses and predicts the benefit of radiotherapy for women with ductal carcinoma in situ (DCIS) following breast-conserving surgery (BCS).
PERTH, Australia – Neuren Pharmaceuticals Ltd.’s stock nearly doubled on positive top-line phase III results for trofinetide in Rett syndrome, meeting all primary and secondary endpoints in the pivotal phase III trial run by partner Acadia Pharmaceuticals Inc.
Nextsense Inc. reported partnerships with global biopharma company UCB SA, Heraus Holding GmbH, the University of California San Diego and Emory University at its first public appearance at the American Epilepsy Society Annual Meeting in Chicago this past weekend. The Nextsense platform uses biosensing earbuds to perform ongoing electroencephalograms (EEGs).
Despite hitting the primary endpoint in its phase III study of pegzilarginase in treating arginase 1 deficiency, Aeglea Biotherapeutics Inc. had a tough go of it Dec. 6 as the price of its stock (NASDAQ:AGLE) plunged 36.5% to close at $3.81 per share. The study hit its primary endpoint with a statistically significant reduction in plasma arginine from baseline after 24 weeks of treatment with pegzilarginase (p<0.0001). The study results were positive enough to prompt Aeglea to say it planned to submit a BLA to the FDA in the first half of 2022.
Shares in Isofol Medical AB dropped by 27% on Dec. 6 as the company informed investors that its ongoing phase III trial of arfolitixorin in metastatic colorectal cancer would not reach the predefined number of events needed to demonstrate a statistically significant effect on progression-free survival (PFS) based on the study’s present statistical plan.
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