Tag Archives: GLP-1RA

Nanexa’s Ph1 QM Liraglutide Study Delayed; SAB Completes Dosing in Ph1 T1DM Trial; Novartis’s Iptacopan IgAN sNDA Receives Priority Review; Ypsomed Partners with Ten23 for Patch Injector; JNJ Q1 ’24 Earnings

A series of cardiometabolic-related news items have been observed from Nanexa, SAB, Novartis, Ypsomed, and J&J. 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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Novo acquires Cardior Pharmaceuticals; Novo initiates Ph2 Dual Agonist Trials in T2DM and Obesity; Esperion CLEAR Outcomes Investor Call

Three cardiometabolic-related news items have been observed: Novo Nordisk announced the acquisition of Cardior Pharmaceuticals for its heart failure asset (view press release); Novo initiated two trials evaluating its GLP-1/GIP dual agonist in obesity (view CT.gov record) and T2DM (view CT.gov record); and Esperion hosted an investor event to discuss the CLEAR Outcomes FDA approval (view presentation). 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.

Rezdiffra Patient and HCP Websites Observed; Terns Q4 ‘23 Earnings

Rezdiffra Patient and HCP Websites Observed; Terns Q4 ‘23 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.

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.

Intarcia CRL’d again, multiple outlets reporting

Multiple outlets are reporting that Intarcia has received a second CRL for ITCA-650 (see Boston Business Journal and STAT News for articles). FENIX has not seen an official company press release but will continue to monitor.

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 Ozempic Switching Study from other GLP-1RA (SUSTAIN SWITCH)

A new CT.gov record for a high-dose semaglutide switching study (SUSTAIN SWITCH) has been observed. In the study, patients will switch from their existing GLP-1RA therapy (not injectable semaglutide) to subcutaneous QW semaglutide (either 0.25 or 0.5mg starting dose) and titrate up to 2.0mg sema. Below, FENIX provides an overview of SUSTAIN SWITCH as well as insight into how Novo Nordisk may leverage the study to pre-emptively position Ozempic vs. Lilly’s tirzepatide.

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.

FENIX Analysis: Rybelsus Launch

Following the September 2019 Rybelsus approval, Novo Nordisk initiated a limited launch in October 2019 to specialists and high-prescribing PCPs. Even with the limited promotional support, Rybelsus appears to be off to a highly successful start, ahead of both Trulicity and Ozempic time-aligned launches. Below, FENIX has conducted a launch analysis, including early insights from NRx trends as well as an overview of both field and digital promotion materials.

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 Ozempic Pen Ph2 Trial

A CT.gov record has been observed comparing FlexTouch (PDS290) to the DV3396 pen which appears to be a modified version of the previously studied DV3372 pen (previous FENIX insight). Below, FENIX provides additional insight into Novo’s next-gen semaglutide pen platform.

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.