Tag Archives: Ozempic

Holiday Hangover: FDA Issues Dasiglucagon CRL for CHI; Cytokinetics Ph3 Aficamten Results; NeuroBo Submits Obesity IND; New O5 Algorithm Trial Observed; Tirzepatide in T1DM Trial; Novo Warns Against Counterfeit Ozempic in US; Glucotrack Preclinical Implantable CGM Data

During the holiday break, a series of cardiometabolic-related news items were observed from Zealand, Cytokinetics, NeuroBo, Insulet, Royal North Shore Hospital, Novo Nordisk, and Glucotrack. Below, FENIX provides highlights and insights for the respective news items.

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Novo Expands Production Facilities in France; Novo to Reduce Production of Victoza for Ozempic Supply; Mounjaro vs. Ozempic in Real-World Study; Kaleido Launches AID System; Biodexa Acquires T1DM Asset; 89bio Long-term MASH Data; Dario Contracts for Cardiometabolic Solution

A series of cardiometabolic-related news items have been observed from Novo Nordisk, Truveta, ViCentra, Biodexa, 89bio, and Dario. Below, FENIX provides highlights and insights for the respective news items.

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Zepbound (tirzepatide) Label and Website Analysis

FDA recently approved Lilly’s tirzepatide, branded as Zepbound, for the treatment of adults who are obese or overweight with weight-related comorbidities such as hypertension, T2DM, OSA, or CVD (view label; previous FENIX insight). Below, FENIX has conducted a Zepbound label, website, and pricing analysis, including thoughts on Lilly’s innovative targeting of employers.

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Novo Initiates Ph2 Cagrisema Trial in CKD and T2DM; Carmot Initiates Ph2 GLP-1/GIP RA Study in Obesity and T1DM; OptumRx Lowers Insulin Costs; Beta Bionics Gains Coverage for iLet Bionic Pancreas; Mark Estes Joins Biolinq; Belgium and Britain Ban Ozempic for Weight Loss

A series of cardiometabolic-related news items have been observed from Novo, Carmot Therapeutics, OptumRx, Beta Bionics, and Biolinq. Below, FENIX provides highlights and insights into the respective news items.

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SELECT Receives Priority Review; High-dose Oral Sema Delayed; Novo Q3 ’23 Earnings

Novo Nordisk hosted its Q3 ’23 earnings call (press release; slides) and provided updates across its CVRM portfolio. Novo provided important new disclosures including SELECT’s priority review, a high-dose oral sema regulatory filing delay, and a new subcutaneous amycretin asset in Ph1 development. Below, FENIX provides highlights and insights from the call, including thoughts on why SC amycretin makes sense from a strategic standpoint.

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Novartis Q3 ’23 Earnings; Counterfeit Ozempic Hospitalizes Patients in Austria; NexImmune Extends Partnership with Yale and JDRF

Three cardiometabolic-related news items have been observed: Novartis hosted its Q3 ‘23 earnings call (press release; slides); several people have been reportedly hospitalized in Austria after using suspected fake versions of Novo’s Ozempic (view article); and NexImmune announced its research partnership with Yale and JDRF has been extended (view press release). Below, FENIX provides highlights and insights into the respective news items.

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Ozempic Label Update; AZ, BMS, Merck, and BI to Participate in Medicare Price Negotiations; FDA and Health Canada Clear Expansion Portion of Biomea’s Ph2 Oral Menin Inhibitor Trial in T2DM

Three cardio-metabolic related news items have been observed: FDA updated the Ozempic label to include ileus (intestinal blockage) as an adverse reaction reported post-approval (view updated label); AZ, BMS, Merck, and BI have reportedly agreed to participate in the first round of Medicare price negotiations (view article); and Biomea Fusion announced FDA and Health Canada cleared the expansion portion of its Ph2 COVALENT-111 study evaluating BMF-219, an oral covalent menin inhibitor, in T2DM (view press release). Below, FENIX provides highlights and insights into the respective news items.

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Rockley Photonics Progresses Non-Invasive, Optical Blood Glucose Monitoring; Intercept to be Acquired by Alfasigma; EMA to Discuss GLP-1RA-Associated Aspiration Risks; Kallyope Initiates Ph2 trial of Oral Obesity and T2DM Treatment

Four cardiometabolic-related news items have been observed: Rockley Photonics announced it is continuing to make progress on non-invasive glucose sensing with its wearable silicon photonics-based sensor (view press release); Intercept announced it has entered a definitive agreement to be acquired by Alfasigma (view press release); EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) will reportedly be discussing aspiration-related risks associated with GLP-1RAs in its September 2023 meeting (view article); and Kallyope announced it initiated a Ph2 trial evaluating K-757 and K-833, oral nutrient receptor agonists, for the treatment of obesity and T2DM (view press release). Below, FENIX provides highlights and insights into the respective news items.

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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.

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