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.
A series of cardiometabolic-related news items have been observed from Altimmune, Lilly, 89bio, Ypsomed, and JDRF. Below, FENIX provides highlights and insights into the respective news items.
Two cardiometabolic-related news items have been observed: Viking Therapeutics announced positive results from its Ph1 QD oral VK2735 (GLP-1/GIP dual agonist) trial and hosted an associated webcast (press release; webcast); and the US District Court for the District of Delaware found Dexcom was infringed on one of three Abbott CGM patents (view article). Below, FENIX provides highlights and insights for the respective news items.
Three cardiometabolic-related news items have been observed: Novo Nordisk announced the acquisition of Cardior Pharmaceuticals for its heart failure asset (view press release); Novo initiated two trials evaluating its GLP-1/GIP dual agonist in obesity (view CT.gov record) and T2DM (view CT.gov record); and Esperion hosted an investor event to discuss the CLEAR Outcomes FDA approval (view presentation). Below, FENIX provides highlights and insights for the respective news items.
Two cardiometabolic-related news items have been observed: Novo Nordisk initiated REIMAGINE 1 (view CT.gov record) and REIMAGINE 3 (view CT.gov record) as the third and fourth trials in its cagrisema T2DM pivotal program; Esperion announced FDA approved CLEAR Outcomes (view press release) and CHMP adopted a positive opinion (view press release). Below, FENIX provides highlights and insights for the respective news items.
FDA recently approved the Wegovy label expansion to reduce the risk of MACE in adults with either overweight or obesity and established CVD (view updated Wegovy label; previous FENIX insight). The label expansion is based on the SELECT CVOT which demonstrated a -20% RRR in 3P-MACE for non-T2DM people with established CVD who were treated with QW 2.4mg injectable semaglutide (previous FENIX insight). Following the approval, Medicare has issued guidance to Part D plans stating anti-obesity drugs also treating medically accepted indications should be reimbursed (view article). Below, FENIX has conducted a Wegovy label analysis, including insight into the impact of the recent CMS decision.
Two cardiometabolic-related news items have been observed: CHMP adopted a positive opinion, recommending marketing authorization for “Awiqli” (QW insulin icodec) for the treatment of diabetes in adults (view press release); and Oprah hosted a show on ABC titled, “Shame, Blame, and the Weight Loss Revolution” which addressed the stigma associated with obesity and the success of GLP-1RAs (view article; watch episode on HULU). Below, FENIX provides highlights and insights for the respective news items, including brief thoughts on the social media hype following Oprah’s TV special.
Three cardiometabolic-related news items have been observed: Inventiva announced positive interim Ph2a LEGEND MASH trial results (press release; slides); Madrigal priced an upsized $600M public offering (view press release); and 89bio’s Ph3 ENLIGHTEN-Fibrosis trial in MASH has been posted to CT.gov (view CT.gov record). Below, FENIX provides highlights and insights for the respective new items.
Three cardiometabolic-related news items have been observed: The CHMP agenda for this month’s meeting (March 18-21) has been released and Novo Nordisk’s insulin icodec is up for an opinion (view CHMP agenda); Galmed announced it was granted an EU patent for the combination of aramchol and resmetirom for the treatment of MASH and liver fibrosis (view press release); and Sequel Med Tech announced it received 510(k) clearance for the twiist AID system (view press release). Additionally, FENIX has provided a correction to Novo’s new Rybelsus doses based on information from its Q3 2023 earnings press release. Below, FENIX provides highlights and insights into the respective news items.
Rezdiffra Patient and HCP Websites Observed; Terns Q4 ‘23 Earnings