The Phase III APPOINT-PNH study, testing iptacopan in treatment-naïve PNH patients, met its primary endpoint, positioning the oral drug as a potential new competitor to Soliris and Ultomiris.
Novartis AG has two successful Phase III clinical trials in hand for its targeted factor B inhibitor iptacopan in patients with paroxysmal nocturnal hemoglobinuria (PNH), positioning the drug for a regulatory filing in 2023 and eventually a commercial face off with AstraZeneca PLC's C5 inhibitors Soliris (eculizumab) and Ultomiris (ravulizumab).
The company announced on 8 December that the Phase III APPOINT-PNH study, testing iptacopan in treatment-naïve patients with PNH, was a success
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
Seven years after acquiring it, Viatris will seek approval of a meloxicam formulation for acute pain backed by data from two Phase III studies in post-surgical pain settings.
The Phase I results are the best to date among ANGPTL3-targeting candidates in the pipeline, but analysts will wait for further updates before predicting a likely winner.
Houman Ashrafian tells delegates at Swiss Biotech Day that ‘literally only two things matter in our industry – target credentialing and differentiated pharmacology. The rest is execution.’
Houman Ashrafian tells delegates at Swiss Biotech Day that ‘literally only two things matter in our industry – target credentialing and differentiated pharmacology. The rest is execution.’
Phase IIa data for ANGPTL4-targeted antibody shows reduced triglycerides and remnant cholesterol, which Marea asserts indicates potential to protect against cardiovascular outcomes.
Already dominating in later lines of breast cancer treatment, Enhertu could now displace both chemotherapy combinations and Roche’s Kadcyla in early-stage HER2-positive patients.
