Category Archives: SGLT2i

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.

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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.

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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.

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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.

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Purchase Blast$599.00

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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.

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Purchase Blast$599.00

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Pfizer Q4 ’22 Earnings; Lilly Initiates Open-Label SURPASS-SWITCH-2 Study; Fractyl Health Announces Positive Week 24 REVITA-T2Di Data; Sciwind Initiates Dosing for Ph3 Ecnoglutide Trials in China; Lifescan Announces Publication of Connected BGM RWE

A series of cardiometabolic-related news items have been observed from Pfizer, Lilly, Fractyl Health, Sciwind, and Lifescan. Below, FENIX provides highlights and insights into the respective news items including thoughts on Pfizer’s oral GLP-1RA selection and and Lilly’s strategy for conducting SURPASS-SWITCH-2.

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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Purchase Blast$599.00

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Viatris’s Generic Dapagliflozin and Lilly’s Trulicity Pediatric Extension Receive Positive CHMP opinions; Medtronic’s Wearable Partner Files for Bankruptcy; Nemaura Looks to Raise Additional Capital

Four cardiometablic-related news items have been observed: Viatris’s generic dapagliflozin received a positive CHMP opinion for the treatment of T2DM, HF, and CKD (view opinion); Lilly’s Trulicity received a positive CHMP opinion for a label extension to include patients ages 10 years and older (view opinion); Medtronic’s wearable partner, Rockley Photonics Holdings Limited, has filed for bankruptcy (view Form 8-K); Nemaura announced it has entered into a definitive agreement of ~$8.4M registered direct offering and concurrent private placement with two healthcare-focused US institutional investors (view press release). Below, FENIX provides highlights and insights including thoughts on an acquisition opportunity for Medtronic.

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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Purchase Blast$599.00

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Abbott Q4 ’22 Earnings; Tidepool Loop Receives FDA Clearance; Lilly to Expand Incretin Manufacturing Capacity; Novo Receives Marketing Practices Complaint; AGC Biologics to Manufacture Tzield; Nemaura Reports Positive Miboko Data; J&J Q4 ’22 Earnings; and Embecta Opens New Headquarters

A series of cardiometabolic-related news items were observed from Tidepool, Lilly, Novo, Embecta, AGC Biologics, and Nemaura. Additionally, Abbott and J&J hosted Q4 ’22 earnings calls. Below, FENIX provides highlights and insights into the respective news items including commentary on why the claims against Novo’s marketing practices seem unfounded.

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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Purchase Blast$599.00

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Another Branded SGLT2i Approved by FDA; Tandem Completes AMF Medical Acquisition; January CHMP Agenda

Three cardiometabolic-related news items have been observed: TheracosBio announced FDA approved Brenzavvy (bexagliflozin), a QD 20mg oral SGLT2i, for the treatment of T2DM (view press release; label); Tandem announced it completed the acquisition of AMF Medical (view press release); and the CHMP agenda (view here) for this month’s meeting (January 23-26) has been released. Below, FENIX provides highlights and insights into the respective news items including an in-depth analysis of Brenzavvy could be another Nesina.

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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Purchase Blast$599.00

You can read the article’s full content online after purchase.

Jardiance CKD sNDA Accepted by FDA Without Priority Review

BI/Lilly announced FDA accepted the Jardiance (empagliflozin) sNDA for the treatment of adults with CKD. According to the press release, the sNDA is based on results from the Ph3 EMPA-KIDNEY trial which demonstrated Jardiance significantly reduced the risk of kidney disease progression or CV death in adults with CKD (view CT.gov record; previous FENIX insight). Below, FENIX provides brief thoughts regarding the EMPA-KIDNEY sNDA filing and the projected PDUFA date.

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.