Category Archives: Dual/triple agonist

Entera Bio to Collaborate with OPKO Biologics for Obesity; Dexcom Launches Dexcom ONE in France; Altimmune Completes Ph2 Obesity Trial Dosing; Vertex Acquires Novel GPCR-targeted Program

Four cardiometabolic-related news items have been observed: Entera Bio and OPKO Biologics entered into a research collaboration agreement for OPKO’s long-acting GLP-2 peptide and certain oxyntomodulin (OXM) analogs (view press release); Dexcom announced Dexcom ONE has been launched in France (with reimbursement) for patients two years of age and older with T1DM and T2DM, who are undergoing intensive insulin therapy (view press release); Altimmune announced the completion of dosing in its 48-week Ph2 MOMENTUM trial, evaluating the safety and efficacy of pemvidutide in patients with obesity or overweight (view press release); and Septerna announced it signed a definitive asset purchase agreement with Vertex for an undisclosed discovery-stage GPCR program (view press release). Below, FENIX provides highlights and insights into the respective news items.

This content is for Read Less members only.
Register
Already a member? Log in here

September CHMP Agenda; Nemaura Announces Interim 24-Hour Wear sugarBEAT Results; Madrigal Appoints Bill Sibold as CEO

Three cardiometabolic-related news items have been observed: The CHMP agenda (view here) for this month’s meeting (September 11-14) has been released; Nemaura Medical announced interim results from a 100-patient study across 4 cohorts of 25 (view press release); and Madrigal Pharmaceuticals announced Bill Sibold as the successor to Paul Friedman as CEO (view press release). Below, FENIX provides highlights and insights into the respective news items.

This content is for Read Less members only.
Register
Already a member? Log in here

NICE Recommends Mounjaro for T2DM

A final draft guidance from the UK’s NICE now recommends Mounjaro for T2DM (view article). According to the article, final guidance from NICE is scheduled to be published on Oct 11, 2023, and the drug will be made available in the UK’s National Health Service (NHS) within 90 days. Recall, in June 2023, NICE did not recommend Mounjaro as a treatment for T2DM and asked Lilly for more data (previous FENIX insight). Below, FENIX provides brief thoughts on the NICE recommendation.

This content is for Read Less members only.
Register
Already a member? Log in here

Novo Partners with Broad Institute of MIT and Harvard for T2DM; Viking Initiates Ph2 Dual Agonist Obesity Trial; Cytokinetics Initiates Ph3 Aficamten Trial in Non-Obstructive HCM

Three cardiometabolic-related news items have been observed: The Broad Institute of MIT and Harvard announced a research partnership with Novo Nordisk to identify drug targets for T2DM and genetic roots of cardiac fibrosis (view press release); Viking Therapeutics initiated a Ph2 trial evaluating the company’s SC QW GLP-1 + GIP dual agonist, VK2735, in obese and overweight patients (view press release); and Cytokinetics initiated a pivotal Ph3 trial of aficamten in patients with non-obstructive hypertrophic cardiomyopathy (nHCM; view press release). Below, FENIX provides highlights and insights into the respective news items.

This content is for Read Less members only.
Register
Already a member? Log in here

Novo and Lilly Win Again with Positive STEP HFpEF Full Results

Novo Nordisk announced positive full results from the Ph3 STEP HFpEF trial (view CT.gov record) demonstrating QW semaglutide 2.4mg led to reductions in HF-related symptoms, reductions in physical limitations, and improvements in exercise functions vs. placebo. The full results were presented at the ESC 2023 (August 25-28) conference in Amsterdam, Netherlands, and simultaneously published in the NEJM (view publication). Importantly, Novo stated it anticipates filing for the Wegovy label update in H1 2024 following the completion of STEP HFpEF-DM (view CT.gov record) in participants with HFpEF and obesity with T2DM in Q4 2023. Below, FENIX provides an overview of the STEP HFpEF results as well as thoughts on the impact to the HFpEF treatment paradigm, including potential readthrough to Lilly and other manufacturers looking to enter the obesity market.

This content is for Read Less members only.
Register
Already a member? Log in here

Novo Partners with Thermo Fisher as Second Wegovy Manufacturer; Bayer Initiates New Finerenone HF Study; Welldoc’s BlueStar Receives 510(k) Clearance for CGM-mediated Dose Recommendations

Three cardiometabolic-related news items have been observed: Novo Nordisk has hired Thermo Fisher as its second contract manufacturer for Wegovy (view article); Bayer initiated a Ph3 study evaluating the safety and efficacy of finerenone in patients hospitalized with acute decompensated HF and mildly reduced or preserved LVEF (REDEFINE-HF; view CT.gov record); and Welldoc announced it received its eleventh 510(k) clearance for BlueStar to provide bolus insulin dose recommendations based on CGM data (view press release). Below, FENIX provides highlights and insights into the respective news items.

This content is for Read Less members only.
Register
Already a member? Log in here

Medtronic CY Q2 ’23 (FY Q1 ’24) Earnings; Lilly Initiates Retatrutide Test Device Study

Two cardiometabolic-related news items have been observed: Medtronic hosted its CY Q2 ’23 (FY Q1 ’24) earnings call (press release; slides); and Lilly initiated a Ph1 relative bioavailability study comparing SC retatrutide (LY3437943) administered by a test device vs. a reference device in healthy participants (view CT.gov record). Below, FENIX provides highlights and insights into the respective news items.

This content is for Read Less members only.
Register
Already a member? Log in here

Novo Q2 ’23 London Earnings; Akero Q2 ’23 Earnings Update

Two cardiometabolic-related news items have been observed: Novo Nordisk hosted its post-Q2 ’23 London earnings call (view webcast); and Akero reported its Q2 ’23 earnings (view press release). Below, FENIX provides highlights and insights from the respective news items.

This content is for Read Less members only.
Register
Already a member? Log in here

Novo Nordisk Q2 ’23 Earnings Update

Novo Nordisk hosted its Q2 ’23 earnings call (view press release; slides) and provided updates across its CVRM portfolio, including the recently announced SELECT CVOT topline results, Wegovy supply, and the high-dose oral semaglutide regulatory submission. Importantly, senior management disclosed plans to present full SELECT CVOT results at AHA 2023 in Philadelphia (November 11-13). Below, FENIX provides highlights and insights from the earnings call.

This content is for Read Less members only.
Register
Already a member? Log in here