Category Archives: GLP-1RA + Basal

New Novo Once-Monthly Dual-Agonist; Icodec Delayed; Novo Q4 ’23 Earnings Updates

Novo Nordisk hosted its Q4 ’23 earnings call (press release; slides) and provided updates across its CVRM portfolio. The company made a number of important disclosures during the call, including a new QM GLP-1+GIP dual agonist in development, QW insulin icodec has been delayed in the US, STEP HFpEF has been filed in the US and EU, and more. Additionally, Novo reminded its 2024 CMD is being held on March 7, 2024. Of note, FENIX will also cover Novo’s London Q4 ’23 earnings call tomorrow, February 1, 2024. Below, FENIX provides highlights and insights from the call.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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SELECT up for CHMP Opinion?; January CHMP Agenda; Akero Initiates Ph3 EFX MASH Trial

Two cardiometabolic-related news items have been observed: the CHMP agenda (view here) for this month’s meeting (January 22-25) has been released and includes Novo’s SELECT; and Akero initiated the second Ph3 study evaluating EFX in participants with non-cirrhotic MASH and F2 or F3 fibrosis (SYNCHRONY Histology; view CT.gov record). Below, FENIX provides highlights and insights for the respective news items.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

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JPM 2024 Day 2: ABT, PODD, NVO, LLY, AZN, BAY, BMF, TDOC; Embecta Files 510(k) for T2DM Patch Pump; Omada Partners with Amazon for Cardiometabolic Programs

On the second day of JPM 2024, FENIX has provided coverage of presentations by major CVRM companies, including Abbott, Insulet, Novo Nordisk, Lilly, AZ, Bayer, Biomea, and Teladoc. GSK and Sanofi also presented at JPM 2024 but had no meaningful discussion relating to their respective CVRM portfolios. Separately, two CVRM-related news items have been observed: Embecta announced it submitted a 510(k) filing to FDA for its open-loop patch pump for T2DM (view press release); and Omada Health announced a partnership with Amazon’s Health Condition Programs for its cardiometabolic programs (view press release).

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

You can read the article’s full content online after purchase.

JPM 2024 Day 1: DXCM, MDT, AMGN, AKERO, ARWR, CYTO, NVS, VRTX, ALN, REGN; Tandem X2 Control-IQ Integrated with Libre 2 Plus; Supersapiens Launches Diabetes Platform; Novo Ph3 Icosema Results

On the first day of JPM 2023, FENIX has provided coverage of presentations by major CVRM companies, including Dexcom, Medtronic, Amgen, Akero, Arrowhead, Cytokinetics, Novartis, Vertex, Alnylam, and Regeneron. Pfizer and Merck also presented at JPM 2024 but had no meaningful discussion relating to their respective CVRM portfolios. Additionally, three separate CVRM-related news items have been observed: Tandem and Abbott announced the Tandem X2 Control-IQ AID system now integrates with Abbott’s Libre 2 Plus CGM (view press release); Novo announced topline results from the COMBINE 3 study evaluating icosema vs. basal-bolus treatment in T2DM (view press release); and Supersapiens announced the launch of its Supersapiens Diabetes platform (view post).

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

You can read the article’s full content online after purchase.

SAB Initiates Ph1 T1DM study; Lilly Continues Verve Investment; Arecor Expands Collaboration with Lilly; Avidity Expands CV Partnership with BMS

Four cardiometabolic-related news items have been observed from SAB Biotherapeutics, Verve/Lilly, Arecor/Lilly, and Avidity/BMS. Below, FENIX provides highlights and insights for the respective news items.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Medtronic CY Q3 ’23 (FY Q2 ’24) Earnings; Lilly to Build Production Plant in Germany; Lilly Initiates Ph1 T2DM Study; Carmot Files for IPO

Four cardiometabolic-related news items have been observed: Medtronic hosted its CY Q3 ’23 (FY Q2 ’24) earnings call (press release; slides); Lilly announced plans to build a $2.5B production plant in western Germany to support diabetes/obesity supply (view press release); Lilly initiated a Ph1 study evaluating an unknown compound (LY3938577) vs. insulin degludec (view CT.gov record); and Carmot Therapeutics has filed for an IPO (view SEC filing). Below, FENIX provides highlights and insights for the respective items.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

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Novo London Q3 ’23 Earnings; Terns Doses First Patient in Ph1 Obesity Trial; Ionis, Regeneron, and Dario Q3 ’23 Earnings

A series of cardiometabolic-related news items have been observed from Novo Nordisk, Terns, Ionis, Regeneron, and Dario. Below, FENIX provides highlights and insights into the respective news items.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

EMA Raises Thyroid Safety Concern Over GLP-1RAs; Madrigal Presents New MAESTRO-NASH Data; Expanded Libre 2 Coverage in France; Bayer Initiates Finerenone CKD + T1DM study; Bigfoot RWE Data Published; Mannkind Initiates INHALE-3 Switching Study

A series of cardiometabolic-related news items have been observed from EMA, Madrigal, Abbott, Bayer, Bigfoot, and Mannkind. Below, FENIX provides highlights and insights in the respective news items.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Novo Files Lawsuit Over Third-Party Semaglutide Promotion; Versanis Bio Completes Enrollment of Ph2b Bimagrumab Study in Obesity; FDA Approves Jardiance and Synjardy for Pediatric T2DM and Lodoco for ASCVD

Four cardiometabolic-related news items have been observed: Novo Nordisk announced it is taking legal actions over third-party semaglutide promotion (view press release); Versanis Bio announced it completed enrollment for the global Ph2b BELIEVE study evaluating the safety and efficacy of bimagrumab as a monotherapy and in combination with semaglutide in participants with obesity (view CT.gov record); FDA approved Jardiance and Synjardy to improve glycemic control in children 10 years of age and older with T2DM (view press release) as well as Agepha Pharma’s Lodoco in adult patients with established ASCVD or with multiple risk factors for cardiovascular disease (view press release). Below, FENIX provides highlights and insights into the respective news items, including brief thoughts on the bimagrumab + semaglutide program. 

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Wegovy Advertising Paused Due to High Demand; Inventiva Ph2 Lanifibranor T2DM and NAFLD Results; FDA Accepts Gan & Lee’s Bs-Aspart BLA

Three cardiometabolic-related news items have been observed: Ro has reportedly paused its Wegovy advertising due to the ongoing supply shortage (view article); Inventiva announced positive topline results from its Ph2 trial evaluating lanifibranor in patients with T2DM and NAFLD (view press release); and Gan & Lee announced FDA accepted the BLA for its biosimilar insulin aspart (view press release). Below, FENIX provides highlights and insights into the respective news items, including thoughts on the ongoing Wegovy supply issues.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.