Sage Therapeutics Inc. on March 17 disclosed another batch of positive phase III data with zuranolone, its oral, once-daily, two-week therapy for the treatment of major depressive disorder (MDD) and postpartum depression. News regarding the GABAA receptor-positive allosteric modulator came the same day that Praxis Precision Medicines Inc. reported fourth-quarter and full-year financial results, updating investors on PRAX-114, its drug in the same class for MDD.
Inflarx NV has submitted a special protocol assessment (SPA) to the FDA for the phase III trial with vilobelimab against the skin disorder hidradenitis suppurativa (HS), pleasing investors with clarity regarding the path forward for the drug, which is in the works for antineutrophil cytoplasmic antibody-associated vasculitis (AAV) as well – and faces competition on both fronts.
Top-line from Orphazyme A/S’ phase II/III trial of arimoclomol for treating inclusion body myositis, a muscle-wasting disease, failed to hit its primary and secondary endpoints. The data caused investors to pull back sharply as shares of Copenhagen-based Orphazyme (NASDAQ:ORPH) had dropped 28.97% on March 29 to close at $8.80 per share.
Shares of Humanigen Inc. (NASDAQ:HGEN) leapt 54.5% to $21.61 March 29 on news that its monoclonal antibody, lenzilumab, improved the relative likelihood of survival without mechanical ventilation in hospitalized patients with COVID-19, setting the company up to submit an application for emergency use authorization (EUA) in the U.S. "as soon as possible," it said. Separately, a combination of two monoclonal antibodies, the Eli Lilly and Co.-Abcellera Biologics Inc.-developed therapy bamlanivimab and the Vir Biotechnology Inc.-Glaxosmithkline plc candidate VIR-7831, demonstrated a 70% relative reduction in persistently high SARS-CoV-2 viral load at day seven compared to placebo for low-risk adult patients with mild to moderate COVID-19, the companies reported.
Arbutus Biopharma Corp. this month gained the go-ahead from regulators to start a phase Ia/Ib trial with its oral capsid inhibitor, AB-836, for the treatment of chronic hepatitis B virus (HBV) infection, an event that drew more attention to the busy space and brought renewed speculation about RNAi bids against HBV, including Arbutus’ own.
Vetex Medical Ltd.'s Revene thrombectomy catheter reduced symptoms and improved quality of life in all patients with iliofemoral vein thrombus in a European clinical study. The results were presented at Venous 2021, the annual meeting of the American Venous Forum.
Genetron Holdings Ltd. said its blood-based, early screening test for hepatocellular carcinoma (HCC) demonstrated 88% sensitivity and 93% specificity in 1,615 subjects in China vs. 71% sensitivity and 95% specificity with the use of ultrasound plus alpha-fetoprotein (AFP). The primary outcome, unveiled on March 25, came from a multicenter prospective trial that Beijing-based Genetron initiated together with The National Cancer Center China in 2019.
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