Category Archives: Topics

July CHMP Agenda; Hims & Hers Appoints Kåre Schultz to BOD; G&L Ph2b Obesity Results; Tirzepatide and Semaglutide Approved in China for Obesity

A series of cardiometabolic-related news items have been observed from EMEA, Hims & Hers, Gan & Lee, and Lilly. 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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Abbott and Novartis Q2 ’24 Earnings

Two cardiometabolic-related news items have been observed: Abbott (press release; infographic) and Novartis (press release; slides) hosted their respective Q2 ’24 earnings calls. Below, FENIX provides highlights and insights about 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

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

Roche Positive Ph1 Oral GLP-1RA Obesity Results

Roche announced positive topline results for CT-996 (QD oral GLP-1RA) from its ongoing Ph1 trial in participants with and without T2DM (view CT.gov record). According to the press release, treatment with CT-996 resulted in a clinically meaningful placebo-adjusted mean weight loss of -6.1% within four weeks (p <0.001). Following the news, Roche’s stock increased ~7.5%. Below, FENIX provides highlights and brief thoughts on the potential CT-996 differentiation.

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.

Roche Ph1b Obesity Results; CordenPharma Invests $982M to Expand GLP-1RA Capacity in US and EU; Lexicon Receives PDUFA Date for Sotagliflozin in T1DM; Lexicon Publishes Additional Inpefa Cost-Effectiveness Analysis

A series of cardiometabolic-related news items have been observed from Roche, CordenPharma, and Lexicon Pharmaceuticals. 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.

Ozempic Associated with Decreased Risk of Dementia Among Other Outcomes

Findings from a University of Oxford study published in the Lancet demonstrated Ozempic decreased the risk of developing dementia by 48% vs. sitagliptin after one year and protected against other cognitive problems (view article; view study). For context, the study evaluated 12-month neurological and psychiatric outcomes of semaglutide vs. sitagliptin, empagliflozin, and glipizide using electronic health records. Below, FENIX provides highlights and insights into the study’s findings.

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.

Pfizer Advances QD Danuglipron; Skye Establishes Clinical Advisory Board; Tonghua Dongbao Discontinues BioChaperone Combo Partnership with Adocia; FTC Prepares to Sue Three Largest PBMs

A series of cardiometabolic-related news items have been observed from Pfizer, Skye Biosciences, Adocia, and the FTC. 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.

Novo Nordisk’s QW Insulin Icodec Receives CRL

Novo Nordisk announced FDA issued a CRL regarding the QW insulin icodec BLA for the treatment of diabetes. According to the press release, the CRL outlines requests related to the manufacturing process and the T1DM indication. Novo stated it is evaluating the content of the CRL and will work closely with FDA to fulfill the requests. Of note, Novo does not expect to be able to fulfill the requests during 2024. Below, FENIX provides brief thoughts on the CRL in the context of the recent negative FDA adcom vote.

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.

Roche CGM Receives CE Mark; Lilly Beats Novo in GLP-1RA Observational Study; Pfizer Leadership Change; FTC Releases Prescription Drug Middlemen Interim Staff Report

A series of cardiometabolic-related news items have been observed from Roche, Lilly, Pfizer, and the FTC. 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.

Mounjaro Olympics DTC; Xeris CEO Succession Plan; Lexicon Appoints New CEO and Director; Inventiva NATiV3 Lanifibranor Updates

A series of cardiometabolic-related news items have been observed from Lilly, Xeris Biopharma, Lexicon Pharmaceuticals, and Inventiva. 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.

BI Announces Triple Agonist for Obesity Treatment; Merck Initiates Ph2a Trial of Efinopegdutide in MASLD

Two cardiometabolic-related news items have been observed: Boehringer Ingelheim and Gubra announced the launch of a Ph1 trial evaluating its triple agonist, BI 3034701, in obesity (view press release); and Merck initiated a Ph2a trial evaluating Q2W vs. QW administration of efinopegdutide (MK-6024) in MASLD (view CT.gov record). Below, FENIX provides highlights and insights for the respective news items, including thoughts on potential MOAs for BI’s triple agonist.

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.