A series of cardiometabolic-related news items have been observed from Akebia Therapeutics, Inventiva, Supersapiens, Sagimet Biosciences, and NeuroBo Pharmaceuticals. Below, FENIX provides highlights and insights for the respective news items.
On the fourth and last day of JPM 2024, FENIX has provided coverage of presentations by other CVRM companies, including Madrigal, Lexicon, MannKind, and Akebia. Xeris also presented at JPM 2024 but had no meaningful discussion relating to its CVRM portfolio. Separately, one CVRM-related news item has been observed: Novartis has reportedly decided to no longer pursue a Cytokinetics acquisition (view article).
A series of cardiometabolic-related news items have been observed from Akebia, Glooko, Novo, Diasome, and Teladoc. Below, FENIX provides highlights and insights into the respective news items.
Two cardiometabolic-related news items have been observed: Novartis hosted its Q2 ‘23 earnings call and disclosed it is discontinuing the development MBL949 in obesity (view press release; slides); and Akebia Therapeutics announced it has completed the End of Dispute Type A meeting with FDA and plans to resubmit the vadadustat NDA for the treatment of anemia due to CKD in adult patients on dialysis in Q3 ‘23 (view press release). Below, FENIX provides highlights and insights into the respective news items.
Four cardiometabolic-related new items have been observed: Akebia Therapeutics announced it received a written response from FDA denying the vadadustat CRL (view press release); Know Labs published a report showing the accuracy of its non-invasive Bio-RFID blood glucose reading used in combination with algorithm optimization using a light gradient-boosting machine (lightGBM) machine learning model (view press release; view report); XtalPi announced a collaboration with Lilly, using AI plus robotics to uncover first-in-class therapeutics for undisclosed targets (view press release); and Structure Therapeutics announced the first patient has been dosed in its Ph2a study evaluating GSBR-1290 in overweight/obese patients with and without T2DM (view press release). Below, FENIX provides highlights and insights into the respective news items.
Two cardiometabolic-related news items have been observed: Akebia Therapeutics (view press release) hosted its Q1 ’23 earnings call and discussed the recent approval of Vafseo (vadadustat) by the European Commission and regulatory proceedings for vadadustat in the US. Viatris (view press release; slides) also hosted its Q1 ’23 earnings call and provided brief CVRM-related updates. Below, FENIX provides highlights and insights into the respective news items.
Four cardiometabolic-related news items have been observed: Novartis hosted its Q1 ’23 earnings call (press release; slides); Insulet announced its basal-only T2DM pod, Omnipod GO, received FDA clearance for use in T2DM patients 18 years of age or older (view press release); Akebia Therapeutics announced the European Commission granted marketing authorization for Vafseo (vadadustat) for the treatment of symptomatic anemia associated with CKD in adults on chronic maintenance dialysis (view press release); and Sernova announced positive T1DM preclinical data for its implantable Cell Pouch device in combination with Evotec’s iPSC-derived islet-like clusters (view press release). Below, FENIX provides highlights and insight into the respective news items.
Three cardiometabolic-related news items have been observed: NeuroBo Pharmaceuticals announced it has submitted an IND to FDA for a Ph2a trial of DA-1241, a novel G-protein-coupled receptor (GPR119) agonist in development for the treatment of NASH (view press release); Akebia Therapeutics announced positive topline results from the Ph3 FO2CUS trial (view CT.gov record) evaluating vadadustat in hemodialysis patients who were converted from Mircera to three times weekly oral vadadustat for the maintenance treatment of anemia due to CKD (view press release); and Arrowhead Pharmaceuticals announced that it earned a $30M milestone payment from GSK following the start of GSK’s Ph2b trial of GSK4532990 (formerly called ARO-HSD) in patients with NASH (view press release; previous FENIX insight). Below, FENIX provides highlights and insight from the respective news items.
Three cardiometabolic-related news items have been observed: Vertex announced FDA has cleared the VX-264 IND application for the treatment of T1DM (press release); and Akebia Therapeutics (press release) and Dario Health (press release) hosted their respective Q4 ’22 earnings calls. Below, FENIX provides highlights and insights into the respective news items.
A series of cardiometabolic-related news items have been observed from Novo Nordisk, Insulet, MannKind, Gan & Lee, Medtronic, and Akebia. Below, FENIX provides highlights and insights into the respective news items.