Category Archives: Topics

Holiday Hangover: FDA Issues Dasiglucagon CRL for CHI; Cytokinetics Ph3 Aficamten Results; NeuroBo Submits Obesity IND; New O5 Algorithm Trial Observed; Tirzepatide in T1DM Trial; Novo Warns Against Counterfeit Ozempic in US; Glucotrack Preclinical Implantable CGM Data

During the holiday break, a series of cardiometabolic-related news items were observed from Zealand, Cytokinetics, NeuroBo, Insulet, Royal North Shore Hospital, Novo Nordisk, and Glucotrack. 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.

Lilly Partners for Obesity Drug Discovery; Embecta GLP-1RA Commentary

Two cardiometabolic-related news items have been observed: Fauna Bio and Lilly enter into a multi-year agreement to discover obesity targets using Fauna’s AI platform (view press release); and Embecta’s CEO, Dev Kurdiar, provided updates to the company’s patch pump development and the impact of GLP-1RAs (view article). 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.

Structure Tx Oral GLP-1RA Ph2a Results; Akero Doses First Patients in EFX Ph3 Program

Two cardiometabolic-related news items have been observed: Structure Therapeutics announced Ph2a study results and program updates for its oral GLP-1RA (GSBR-1290) and hosted an associated webcast (view webcast; slides); and Akero Therapeutics announced the first patients have been dosed in the SYNCHRONY Ph3 program evaluating efruxifermin (EFX) in MASH (view press release). 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 Buys Alkermes Manufacturing Facility for Oral Assets; Fractyl Announces New Revita Analysis; AZ Initiates Ph2 Oral PCSK9i Study in Dyslipidemia; Nexletol/Nexlizet Label Updates

Four cardiometabolic-related news items have been observed from Novo/Alkermes, Fractyl, AZ, and Esperion. 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.

Alnylam 2023 Pipeline Updates; Pfizer Full-Year 2024 Guidance Call; Zepbound Available Through Ro Body Program; Novo Challenges IRA’s Constitutional Legitimacy; Tandem Source Full Launch in US

A series of cardiometabolic-related news items have been observed from Alnylam, Roche, Ro, Novo Nordisk, and Tandem. 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.

SURMOUNT-4 Results Published in JAMA; December CHMP Agenda; Fractyl Health Presents GLP-1RA PGTx Findings at WCIRDC 2023

Three cardiometabolic-related news items have been observed: Lilly announced detailed results from SURMOUNT-4 have been published in JAMA (view press release; view publication); the CHMP agenda (view here) for this month’s meeting (December 11-14) has been released; and Fractyl Health presented findings from its Rejuva GLP-1RA-based gene therapy candidate (GLP-1RA PGTx) vs. semaglutide at WCIRDC 2023 in Los Angeles, CA on December 7-9, 2023 (view press release). 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.

Sanofi 2023 Investor Day Pipeline Updates; Akero Initiates Ph3 EFX MASH Program; Biomea Presents Data at WCIRDC 2023; Matt Rainville Joins Tandem

Four cardiometabolic-related news items have been observed from Sanofi, Akero, Biomea, and Tandem. 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 Terminates EOFlow Acquistion; t:slim X2 Now Available with Dexcom G7 Integration; Indoco Receives Tentative Approval for Generic Invokana

Three cardiometabolic-related news items have been observed: Medtronic announced it has terminated the EOFlow acquisition (view SEC filing); Dexcom (view press release) and Tandem (view press release) announced the launch of updated t:slim X2 insulin pump software with Dexcom G7 CGM integration in the US; and FDA granted Indoco Remedies a tentative ANDA approval for generic canagliflozin (view press release). Below, FENIX provides highlights and insights into the respective news items, including thoughts on why Medtronic’s decision to terminate the EOFlow deal makes sense.

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.

Zealand 2023 Investor Day Obesity Pipeline Updates; Zepbound Now Available; Inventiva Receives DMC Approval to Continue Ph3 MASH Trial; Ascensia Participates in Film Series for Eversense CGM

Four cardiometabolic-related news items have been observed from Zealand, Lilly, Inventiva, and Ascensia. 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.

Roche to Acquire Carmot; 89bio Ph3 MASH Program

Two cardiometabolic-related news items have been observed: Roche and Carmot Therapeutics announced a definitive merger agreement for Roche to acquire Carmot for $2.7B; and 89bio announced an end-of-Ph2 meeting with FDA for pegozafermin in MASH and disclosed details of the upcoming Ph3 MASH program (view press release). 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.