Category Archives: Uncategorized

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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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.

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.

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.

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.

New Pfizer Obesity Partnership; FDA Lifts Vivani GLP-1RA Implant Clinical Hold; Novo Partners with Biosplice; Sagimet Denifanstat MASH Investor Call

A series of cardiometabolic-related news items have been observed from Pfizer, Vivani Medical, Novo Nordisk/Biosplice Therapeutics, and Sagimet Biosciences. 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.

FDA Clears Abbott’s Lingo and Libre Rio CGMs; Lilly Publishes SYNERGY-NASH Results; Teladoc Appoints New CEO

Three cardiometabolic-related news have been observed: Abbott announced FDA cleared its Lingo and new “Libre Rio” CGM systems for OTC (view press release); Lilly announced detailed results from the Ph2 SYNERGY-NASH trial were presented at EASL 2024 (June 5-8; Milan, IT) and published in the NEJM (view press release); and Teladoc appointed Charles Divita, III, as its CEO effective immediately (view press release). Below, FENIX provides highlights and insights for the respective news items, including thoughts on how Lingo and Libre Rio will compete with Dexcom’s Stelo.

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 Partners with Metaphore for Next-Gen Obesity Assets; Altimmune, Xeris, MannKind, and Viatris Q1 ’24 Earnings

A series of cardiometabolic-related news items have been observed from Novo Nordisk/Metaphore Biotechnologies, Altimmune, Xeris, MannKind, and Viatris. 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.