Category Archives: Other

Ionis Q4 ’22 Earnings; ATTD 2023 Key Press Releases

A series of cardiometabolic-related news items have been observed from Ionis, Dexcom, Ypsomed, Amgen, and MannKind. 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.

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Medtronic and Esperion CY Q4 ’22 Earnings Updates; Akebia Receives Another FDA Response for Vadadustat; Wegovy and Vadadustat CHMP Opinions; February CHMP Agenda

A series of diabetes-related news items have been observed: Medtronic (press release; slides) and Esperion (press release; slides) hosted their respective CY Q4 ’22 earnings calls; Akebia received another FDA response regarding the vadadustat CRL appeal (press release); and the February CHMP Agenda was posted, including vadadustat and Wegovy (potential) opinions. Below, FENIX provides highlights and insights from the respective news items, including thoughts on Medtronic’s Simplera CGM approval timing.

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.

Biocon CY Q4 ’22 Earnings; Arrowhead Regains Rights to NASH Asset; Zydus Receives Tentative Approval for Generic Invokana

Three cardiometabolic-related news items have been observed: Biocon hosted its FY Q3 ’23 (CY Q4 ’22) earnings call (view press release) and disclosed plans to develop a generic tirzepatide; Arrowhead Pharmaceuticals announced it has regained rights to ARO-PNPLA3, formerly JNJ-75220795, which was being developed in collaboration with Janssen for the treatment of NASH (view press release); and FDA granted tentative approval for Zydus Pharmaceutical’s generic canagliflozin (Invokana; view Drugs@FDA). Below, FENIX provides highlights and insights from the respective news items, including brief thoughts on the potential timing of Biocon’s generic 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.

Insulet Acquires Bigfoot’s Insulin Pump IP; Dexcom G7 Receives Medicare Reimbursement; Novo Initiates New Sema Pediatric Obesity Trial; Sanofi Completes $35M Investment in Provention; Sanofi Announces Change in R&D Leadership

A series of cardiometabolic-related news items were observed from Insulet, Bigfoot, Dexcom, Novo Nordisk, and Sanofi. 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.

Novo Nordisk and Heartseed Dose First Patient in Ph1/2 LAPiS Trial of HS-001; Finerenone Receives EU Approval for FIGARO-DKD Label Extension

Two cardiometabolic-related news items have been observed: Novo Nordisk and Heartseed announced the first patient has been dosed in the Ph1/2 LAPiS study (view CT.gov record) evaluating HS-001 in 10 patients with advanced HF caused by ischemic heart disease (view press release); and Kerendia (finerenone) has received EU approval for label extension to include CV outcomes in patients with CKD and T2DM (view Kerendia EPAR). Below, FENIX provides highlights and insights from 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.

AZ Q4 ’22 Earnings; Oramed to Consider M&A Opportunities

Two cardio-metabolic related news items have been observed: AstraZeneca hosted its Q4 ’22 and FY ‘22 earnings call and provided brief updates to its CVRM business, including the ongoing Farxiga LCM initiatives (press release; slides); and Oramed issued an update to shareholders (view here) in which it said the company is conducting a comprehensive analysis of the data from its discontinued Ph3 oral insulin trials. Below, FENIX provides highlights and insights into the respective news items, including thoughts on AZ’s dapa LCM initiatives ahead of its anticipated 2025 LOE.

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.

Vertex Q4 ’22 Earnings; Dario Partners with Dexcom

Two cardiometabolic-related news items have been observed: Vertex hosted its Q4 ‘22 earnings call and provided brief updates to its ongoing T1DM cell-therapy programs (press release; slides); and Dario announced an agreement with Dexcom to integrate Dexcom CGMs into Dario’s multi-chronic condition platform (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.

Dexcom G7 Super Bowl DTC; Medtronic Initiates 780G+DS5 GCM Trial; Forxiga Receives EU Approval for Chronic HF; Merck Initiates Vericiguat Pediatric HF Trial

Four cardiometabolic-related news items have been observed: Dexcom announced plans for a second Super Bowl DTC for the G7 CGM US launch (view press release; commercial); Medtronic initiated a trial evaluating the MiniMed 780G insulin pump used in combination with the DS5 CGM (Simplera) as well as the Medtronic extended infusion set and reservoir (view CT.gov record); Forxiga (dapagliflozin) has received EU approval to expand its HF indication regardless of LVEF (view Forxiga EPAR); and Merck initiated a Ph2/3 trial evaluating the vericiguat in pediatric patients aged 28 days to 18 years (VALOR; view CT.gov record). Below, FENIX provides highlights and insights from the respective news items including commentary on how the Medtronic study could suggest the company may not believe it can achieve iCGM designation.

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 and Regeneron Q4 ’22 Earnings Updates

Two cardiometabolic-related news items have been observed: Sanofi (press release; slides) and Regeneron (press release; slides) hosted their respective Q4 ’22 earnings calls. Below, FENIX provides highlights and insights from the earnings calls.

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, Merck, and Roche Q4 ’22 Earnings Updates

Three cardiometabolic-related news items have been observed: Lilly (press release; slides), Merck (press release; slides), and Roche (press release; slides) hosted their respective Q4 ’22 earnings calls. Below, FENIX provides highlights and insights from the earnings calls. 

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.