Category Archives: SGLT2i

AZ’s Farxiga Receives FDA Approval for DELIVER; Esperion, Xeris, Madrigal, and Sigilon Q1 ’23 Earnings; Ascensia Expands Eversense PASS Program; and Glooko Redesigns App

A series of cardiometabolic-related news items have been observed from AstraZeneca, Ascensia, and Glooko. Additionally, Esperion, Xeris, Madrigal, and Sigilon provided Q1 ’23 earnings updates. 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.

Ionis, Lexicon, and Amarin Q1 ’23 Earnings; AstraZeneca Collaborates with Sernova for Cell Therapies

Four cardiometabolic-related news items have been observed: Ionis (view press release; slides), Lexicon (view press release), and Amarin view press release; slides) hosted their respective Q1 ‘23 earnings calls and provided CVRM-related updates; and Sernova announced a preclinical research collaboration with AstraZeneca to evaluate the use of its Cell Pouch System with AstraZenaca’s therapeutic cells (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.

Intercept, AZ, and Sanofi Q1 ’23 Earnings; Sanofi Completes Provention Acquisition; DRI Sells Tzield Royalties to Sanofi

Five cardiometabolic-related news items have been observed: Intercept (press release; slides), AstraZeneca (press release; slides), and Sanofi (press release; slides) hosted their respective Q1 ’23 earnings calls; Sanofi announced it has completed its acquisition of Provention Bio (view press release); and DRI Healthcare Trust announced that it has sold its Tzield royalty interests and milestone payment obligations to Sanofi for $210M (view press release). Below, FENIX provides highlights and insights from the call.

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.

Lannett Announces Positive Pivotal Bs-Glargine Results; Mark Cuban’s Pharmacy Offers Janssen’s Invokana; Diamyd Partners with JDRF for Ph3 Diamyd T1DM Development

Three cardiometabolic-related news items have been observed: Lannett announced topline results from its bs-glargine U100 pivotal study (view press release; view CT.gov record); Mark Cuban Cost Plus Drug Company (view website) announced it is now offering Janssen’s Invokana, Invokamet, and Invokamet XR (view tweet); and Diamyd Medical announced it entered into a four-year research and development collaboration with JDRF to support its ongoing Ph3 DIAGNODE-3 trial in T1DM (view press release). Below, FENIX provides highlights and insights into the respective news items including potential readthrough from recent insulin price reductions announced by Lilly, Novo, and Sanofi to Lannett’s bs-glargine.

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 Accepts Jardiance Pediatric sNDA; New Teplizumab Pediatric Trial; Sernova Completes Islet Transplantation in First Two Ph1/2 T1DM Patients; Xeris and vTv Therapeutics Q4 ’22 Earnings

A series of cardiometabolic-related news items have been observed: BI/Lilly announced FDA accepted the Jardiance (empagliflozin) pediatric T2DM sNDA (view press release); Provention Bio initiated a Ph4 open-label trial evaluating the safety and PK of teplizumab in participants with Stage 2 T1DM who are <8 years of age (PETITE-T1D; view CT.gov record); Sernova announced the first two patients in the second cohort of its US Ph1/2 clinical trial received their first islet transplant (view press release); and Xeris (press release) and vTv Therapeutics (press release) released their Q4 ’22 earnings. 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.

CLEAR Outcomes Full Results; Abbott Libre 2 and 3 AID Clearance; New Lexicon HF Awareness Campaign; Merck to Advance Oral PCSK9i to Ph3; Amarin Announces Non-Sarissa Board Departures; BI/Lilly COORDINATE-Diabetes Results

A series of cardiometabolic-related news items have been observed from Esperion, Abbott, Lexicon, Merck, and BI/Lilly. 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.

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.

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.

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.