Tag Archives: tirzepatide

Lilly Completes SURMOUNT-2 Trial; FDA Clears Libre 3 Reader; Novo Initiates Ph3 Icodec + Semaglutide Treatment Intensification Trial

Three cardiometabolic-related news items have been observed: On April 13, 2023, the ClinicalTrials.gov record for SURMOUNT-2 was updated to reflect that the trial has been completed; Abbott announced FDA cleared a standalone reader for its FreeStyle Libre 3 iCGM system (view press release); and Novo Nordisk has initiated a Ph3 T2DM trial evaluating icodec as add-on therapy to semaglutide for treatment intensification (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

New Tirzepatide Injection Device Trial; Novo Partners with Aspect Biosystems; Sanofi’s Provention Bio Acquisition Regulatory Issue; Glooko Partners with Hedia

Four cardiometabolic-related news items have been observed: Lilly initiated a Ph1 tirzepatide trial evaluating a new injection device (view CT.gov record); Novo Nordisk and Aspect Biosystems announced a collaboration, development, and license agreement to develop bioprinted tissue therapeutics for diabetes and obesity (view press release); Sanofi announced it has withdrawn and refiled its Premerger Notification and Report Form under the Hart-Scott-Rodino Act of 1976 (HSR Act) for its pending acquisition of Provention Bio (view press release); and Glooko announced a new global partnership with Hedia (view press release). Below, FENIX provides highlights and insights into the respective news items including thoughts on Lilly’s potential new injection device.

This content is for Read Less members only.
Register

Already a member? Log in here

Lilly, Merck, and Roche Q4 ’22 Earnings Updates

Three cardiometabolic-related news items have been observed: Lilly (press release; slides), Merck (press release; slides), and Roche (press release; slides) hosted their respective Q4 ’22 earnings calls. Below, FENIX provides highlights and insights from the earnings calls.

This content is for Read Less members only.
Register

Already a member? Log in here

Pfizer Q4 ’22 Earnings; Lilly Initiates Open-Label SURPASS-SWITCH-2 Study; Fractyl Health Announces Positive Week 24 REVITA-T2Di Data; Sciwind Initiates Dosing for Ph3 Ecnoglutide Trials in China; Lifescan Announces Publication of Connected BGM RWE

A series of cardiometabolic-related news items have been observed from Pfizer, Lilly, Fractyl Health, Sciwind, and Lifescan. Below, FENIX provides highlights and insights into the respective news items including thoughts on Pfizer’s oral GLP-1RA selection and and Lilly’s strategy for conducting SURPASS-SWITCH-2.

This content is for Read Less members only.
Register

Already a member? Log in here

Tirzepatide Receives Fast Track Designation in Obesity; Provention Bio and Sanofi Join Forces for Potential Teplizumab US Launch

Two cardiometabolic-related news items have been observed: Lilly announced FDA granted Fast Track designation for the investigation of tirzepatide in adults that are obese or overweight with weight-related comorbidities; and Provention Bio and Sanofi US announced a co-promotion agreement for the commercialization of teplizumab in the US. Below, FENIX provides highlights and insights for the respective new items.

This content is for Read Less members only.
Register

Already a member? Log in here

Tirzepatide Approved in Japan; Nemaura and EVERSANA Partner for BEATdiabetes; SURMOUNT-MMO Trial Record Posted

Three cardiometabolic-related news items have been observed: Lilly announced tirzepatide is approved in Japan (press release); Nemaura announced a preliminary commercialization agreement with EVERSANA for BEATdiabetes (press release); and Lilly’s Ph3 tirzepatide obesity outcomes trial (SURMOUNT-MMO) has been posted on CT.gov (view CT.gov record). 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

FENIX Analysis: Mounjaro Launch Update

Following approval of Lilly’s Mounjaro (tirzepatide) in T2DM in May 2022 (previous FENIX insight), FENIX has conducted an initial launch analysis, including early insights from prescription trends as well as a look into the Mounjaro promotional, sampling, and copay card tactics.

This content is for Read Less members only.
Register

Already a member? Log in here

Thoughts on SURMOUNT-MMO after SELECT Interim Analysis

At its Q2 ’22 earnings in August, Novo Nordisk disclosed that SELECT, the Wegovy CVOT, would not stop for overwhelming efficacy at a pre-specified interim analysis (previous FENIX insight). With all the hype now passed, the trial design lens turns to Lilly’s tirzepatide obesity CVOT, SURMOUNT-MMO. Below, FENIX provides thoughts on SURMOUNT-MMO, including Lilly’s potential strategy to get a broad metabolic indication, similar to what BI/Lilly did in HF with Jardiance by eliminating LVEF label language.

This content is for Read Less members only.
Register

Already a member? Log in here

Mounjaro WAC Pricing Analysis; Lilly @ UBS 2022

Late last week, Lilly disclosed Mounjaro will be offered at $974.33 WAC across all available doses. Additionally, during Lilly’s fireside chat at UBS 2022 (view replay), Mike Mason, Lilly’s SVP and President of Diabetes briefly commented on Lilly’s pricing rationale for tirzepatide (discussed below). As a follow-up to FENIX’s Mounjaro label and website analysis (previous FENIX insight), FENIX has conducted a Mounjaro pricing analysis, including insight into why Lilly may opt to create a second brand for the tirzepatide obesity indication.

This content is for Read Less members only.
Register

Already a member? Log in here

Lilly Hosts 2021 Investment Community Meeting

Lilly hosted its 2021 Investment Community Meeting (view presentation replay; view diabetes/obesity slides). During the event, Lilly highlighted a new strategy to expand its focus beyond diabetes to include obesity-related diseases (e.g. CV, liver, and kidney) by leveraging tirzepatide’s best-in-class profile. As part of the update, Lilly also provided an overview of the Ph3 QW insulin program as well as an overview of its early CVRM pipeline assets. Below, FENIX provides highlights and insights from the call.

This content is for Read Less members only.
Register

Already a member? Log in here