Category Archives: Topics

Novo’s Ocedurenone CLARION-CKD Trial Fails; NeuroBo Doses First Patient in MAD Ph1 Obesity Trial; Another Generic Liraglutide FDA Approval

Three cardiometabolic-related news items have been observed: Novo Nordisk announced its CLARION-CKD Ph3 trial evaluating ocedurenone (nsMRA) failed to meet its primary endpoint (view CT.gov record; view press release); NeuroBo Pharmaceuticals announced it dosed first patients in the Part 2 MAD portion of its Ph1 trial of DA-1726 for obesity (view CT.gov record; view press release); and Hanyu Pharmaceuticals (and Hikma) announced its liraglutide ANDA has been granted tentative approval (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.

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EXCLUSIVE: FENIX Interview with CGM Newcomer Allez Health (Part 2)

As promised, FENIX delivers on Part 2 of the exclusive interview with Leif Bowman, the co-founder of Allez Health, an emerging biosensor venture founded by veterans in the CGM space. In case you missed it, Part 1 of the exclusive interview covered insights into Allez’s business philosophy and an early look into the features of its CGM (view here). Below, FENIX provides further details on Allez’s launch timelines, data-sharing strategy, and perspective on the market heavyweights, Dexcom and Abbott.

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.

Ionis’s Olezarsen FCS Filing Accepted with Priority Review; Scholar Rock Obesity Development Updates; Zealand Raises $900M Towards Obesity Development; Sernova Ph1/2 Cell Pouch T1DM Updates; Fractyl Pipeline Updates; New Dario Digital Health GLP-1RA Data

A series of cardiometabolic-related news items have been observed from Ionis, Scholar Rock, Zealand, Sernova, Fractyl Health, and Dario Health. 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.

ADA 2024 Key Press Releases (June 24)

On the final day of the ADA 2024 conference, nine cardiometabolic-related news items have been observed from Novo Nordisk, Adipo Therapeutics, Trinity Biotech, Alnylam, Viking, Teva, Teladoc Health, and CHMP. Below, FENIX provides context and analysis for the announcements, including thoughts on the potential FLOW label.

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.

ADA 2024 Key Press Releases (June 23)

On the third day of ADA 2024, four cardiometabolic-related news items have been observed from Senseonics, Altimmune, Fractyl Health, and Gan & Lee. Below, FENIX provides context and analysis for the announcements.

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.

ADA 2024 Key Press Releases (June 22)

On the second day of ADA 2024, six cardiometabolic-related news items have been observed from Insulet, Medtronic, Terns Pharmaceuticals, MannKind, Tandem, and Altimmune. Below, FENIX provides context and analysis for the announcements.

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.

ADA 2024 Key Press Releases (June 21)

On the first day of ADA 2024, three cardiometabolic-related news items were observed: Lilly announced detailed results from its Ph3 SURMOUNT-OSA trial presented at ADA 2024 and published in the NEJM (view press release); Lexicon announced it resubmitted the sotagliflozin NDA for adjunctive treatment of T1DM and CKD (view press release); and Vertex Pharmaceuticals announced new data from its Ph1/2 trial of VX-880 (view press release). Below, FENIX provides context and insight 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.

EXCLUSIVE: FENIX Interview with CGM Newcomer Allez Health (Part 1)

To kick off the ADA 2024 conference, FENIX sat down with Leif Bowman, the co-founder of Allez Health, for an in-depth interview on the company’s goal to disrupt the CGM market. Recall, in May 2024, Allez announced it secured $60M in a Series A+ financing round led by Osang Healthcare Co. Ltd and with participation from existing investors (previous FENIX insight). For context, Allez (formerly called Zense-Life; view website) is an emerging biosensor venture founded by veterans in the CGM space. Below, FENIX provides Part 1 of our exclusive interview which includes insight into Allez’s business philosophy as well as an early look into the features of its CGM.

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.

Omnipod 5 Launch Updates; Zealand Ph1b MAD Petrelintide data; Ypsomed AID Algorithm Approved by FDA; Silence Ph2 siRNA Results; Lilly Fights Compounded Tirzepatide Sales

A series of cardiometabolic-related news items have been observed from Insulet/Dexcom, Zealand, Ypsomed, Silence Therapeutics, 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.

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.

Merck Initiates Ph2a Efinopegdutide Trial in MASH; Lexicon Publishes Cost-Effectiveness Analysis of Inpefa; Novo, Tandem, and Altimmune to Present at ADA 2024

Three cardiometabolic-related news items have been observed: Merck initiated a new Ph2a trial of efinopegdutide in MASH (view CT.gov record); Lexicon Pharmaceuticals published a cost-effective analysis of Inpefa in diabetes and HF (view press release); Novo Nordisk (view press release), Tandem Diabetes Care (view press release), and Altimmune (view press release) announced data presentations at ADA 2024. 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.