Tag Archives: icosema

STEP HFpEF Withdrawn; QM GLP/GIP Withdrawn; Novo Q2 ’24 Earnings

Novo Nordisk hosted its Q2 ’24 earnings call (press release; slides) and provided updates across its CVRM portfolio. Importantly, Novo disclosed it has withdrawn the STEP HFpEF sNDA and it discontinued development of its QM GLP/GIP dual agonist, among other updates. FENIX will cover Novo’s London Q2 ’24 earnings call tomorrow, August 8, 2024. Below, FENIX provides highlights and insights from the Q2 ’24 earnings 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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Novo to Face Two FDA Adcoms in 2024; Novo Q1 ‘24 Earnings

Novo to Face Two FDA Adcoms in 2024; Novo Q1 ‘24 Earnings

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.

Novo Nordisk 2024 Capital Markets Day Highlights and Analysis

Novo Nordisk hosted its 2024 Capital Markets Day and provided updates on the strategic direction of the company across key commercial and R&D activities. Below, FENIX provides details and insights from the event.

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.

Novo Initiates Icosema COMBINE 4 Ph3 Trial; Eccogene Initiates Ph1 Oral GLP-1RA Study; Ionis and Teladoc Q4 ’23 Earnings

A series of cardiometabolic-related news items have been observed from Novo Nordisk, Eccogene, Ionis, and Teladoc. 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

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

Novo London, Merck, Roche, and Sanofi Q4 ’23 Earnings; FDA Clears NeuroBo’s Obesity IND

Five cardiometabolic-related news items have been observed from Novo Nordisk, NeuroBo, Merck, Roche, and Sanofi. Below, FENIX provides the 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.

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.

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.

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.

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 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.

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.

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.

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. 

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.