Category Archives: SGLT2i

Wegovy Faces Supply Shortage in Germany; Abata Announces Novel Pre-clinical Treg Cell Therapy Candidate for T1DM; Bayer Initiates Additional Ph3 Finerenone HF Trials; Merck Initiates Oral PCSK9i CVOT

Four cardiometabolic-related news items have been observed: Novo Nordisk is reportedly having difficulties meeting Wegovy demand in Germany (view article); Abata Therapeutics disclosed its development candidate, ABA-201, to be a disease-modifying Treg cell therapy for T1DM (view press release); Bayer announced it will initiate three additional finerenone Ph3 studies as part of its HF MOONRAKER development program (view press release); and Merck initiated its oral PCSK9i (MK-0616) CVOT (view CT.gov record). 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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Novo Partners with Thermo Fisher as Second Wegovy Manufacturer; Bayer Initiates New Finerenone HF Study; Welldoc’s BlueStar Receives 510(k) Clearance for CGM-mediated Dose Recommendations

Three cardiometabolic-related news items have been observed: Novo Nordisk has hired Thermo Fisher as its second contract manufacturer for Wegovy (view article); Bayer initiated a Ph3 study evaluating the safety and efficacy of finerenone in patients hospitalized with acute decompensated HF and mildly reduced or preserved LVEF (REDEFINE-HF; view CT.gov record); and Welldoc announced it received its eleventh 510(k) clearance for BlueStar to provide bolus insulin dose recommendations based on CGM data (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.

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Purchase Blast$599.00

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

Zealand Q2 ’23 Earnings; TheracosBio Partners with SmithRx for Brenzavvy Access

Two cardiometabolic-related news items have been observed: Zealand Pharma hosted its Q2 ’23 earnings call (press release; slides); and TheracosBio announced a collaboration with SmithRx to offer access to Brenzavvy (bexagliflozin; 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.

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Purchase Blast$599.00

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

Lilly Completes Acquisition of Sigilon and Versanis; Galectin and Nemaura Q2 ‘23 Earnings; August CHMP Agenda

Five cardiometabolic-related news items have been observed: Lilly announced it completed the Sigilon Therapeutics (view press release) and Versanis Bio (view press release) acquisitions; Galectin Therapeutics (view press release) and Nemaura Medical (view press release) reported their respective Q2 ’23 earnings; and the CHMP agenda (view here) for this month’s meeting (August 14-17) has been released. 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 Q2 ’23 Earnings Update

Novo Nordisk hosted its Q2 ’23 earnings call (view press release; slides) and provided updates across its CVRM portfolio, including the recently announced SELECT CVOT topline results, Wegovy supply, and the high-dose oral semaglutide regulatory submission. Importantly, senior management disclosed plans to present full SELECT CVOT results at AHA 2023 in Philadelphia (November 11-13). Below, FENIX provides highlights and insights from the earnings 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.

Insulet, Xeris, Madrigal, and Bayer Q2 ‘23 Earnings

Four cardiometabolic-related news items have been observed: Insulet (view press release; slides), Xeris Biopharma (press release), Madrigal Pharmaceuticals (press release), and Bayer (press release; slides) reported their respective Q2 ‘23 earnings. 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.

Lilly Up Big Following Q2 ’23 Results and SELECT Data Readout

Lilly hosted its Q2 ’23 earnings call (press release; slides) and provided updates across its CVRM portfolio. Of note, Mounjaro led Lilly’s new products category with WW Q2 ’23 sales reaching nearly $1B. Following the Q2 ’23 beat, increased FY 2023 guidance, and bolstered by Novo’s SELECT readout (previous FENIX insight), Lilly’s stock jumped +15% to an all-time high of ~$521/share. Unsurprisingly, Lilly also provided commentary surrounding the SELECT data readout. Below, FENIX provides highlights and insight from the call, including additional thoughts on the evolving obesity CVOT dynamic.

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.

Tandem, Lexicon, and Amgen Q2 ‘23 Earnings

Three cardiometabolic-related news items have been observed: Tandem Diabetes Care (view press release), Lexicon (view press release), and Amgen (press release; slides) hosted their respective Q2 ‘23 earnings calls. 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.

Lilly Initiates Additional Ph3 Orforglipron Trial; Mounjaro Label Update; Vertex, Amarin, and Intercept Q2 ‘23 Earnings; Glenmark Receives ANDA Approval for 2.5mg and 5mg Saxagliptin; Dario Introduces GLP-1RA Obesity Program; Tandem Initiates Sigi Patch Pump Trial

A series of cardiometabolic-related news items have been observed from Lilly, Vertex, Amarin, Intercept, Glenmark, Dario, and Tandem. 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.

Sanofi and AZ Q2 ’23 Earnings

Two cardiometabolic-related news items have been observed: Sanofi (press release; slides; infographic) and AstraZeneca (press release; slides) hosted their respective Q2 ’23 earnings calls. 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.