Category Archives: Topics

Insulet, Vertex, MannKind, and Intercept Q1 ‘22 Earnings Updates

A series of cardiometabolic-related news items have been observed: Insulet (press release), Vertex (press release), MannKind (press release), and Intercept hosted their respective Q1 ‘22 earnings calls. Below, FENIX provides highlights and insights for the respective new 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 Q1 ’22 London Earnings; Lilly Initiates Second Trial in Ph3 QWINT Program; Ionis, Provention Bio, Lexicon, and Lannett Q1 ’22 Earnings Updates

A series of cardiometabolic-related news items have been observed: Novo Nordisk hosted its post-Q1 ’22 earnings event (see previous FENIX insight on Q1 ’22 Novo earnings from April 29); a second trial from Lilly’s Ph3 QW insulin program (BIF; LY3209590) has been observed (view CT.gov record); Lexicon (press release), Ionis (press release; slides), Provention Bio (press release), and Lannett (press release) hosted their respective Q1 ‘22 earnings calls. Below, FENIX provides highlights and insights for the respective new 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.

Tandem, Amarin, and Regeneron Q1 ’22 Earnings Updates

A series of cardiometabolic-related news items have been observed: Tandem (press release), Amarin (press release; slides), and Regeneron (press release; slides) hosted their respective earnings calls. Below, FENIX provides highlights and insights for the respective new 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.

DELIVER Delivers for AZ; Priority Review Depends on CV Death

AstraZeneca announced top-line results from the Ph3 DELIVER trial (view CT.gov record) demonstrating AZ’s Farxiga (dapagliflozin) has met the primary composite endpoint of CV death or worsening HF in HFpEF subjects. Below, FENIX provides initial thoughts.

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 and Genesis Therapeutics Collaboration; Esperion Q1 ’22 Earnings Update; Oramed’s Pivotal Ph3 Oral Insulin Trial Completes Enrollment; MySugarWatch Launches HCP-focused Ad Campaign for sugarBEAT in MIMS

A series of cardiometabolic-related news items have been observed: Genesis Therapeutics announced a strategic collaboration with Lilly; Esperion (press release; slides) hosted its Q1 ‘22 earnings call; Oramed announced the Ph3 study (ORA-D-013-1) of its oral insulin capsule (ORMD-0801) in T2DM has completed enrollment; and Nemaura Medical announced that its UK licensee, MySugarWatch, has launched a series of ads in MIMS as part of a large-scale awareness campaign for the company’s sugarBEAT non-invasive CGM. Below, FENIX provides highlights and insights for the respective new 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.

Beta Bionics Insulin-only iLet Pivotal Trial Results @ ATTD 2022; Vertex’s Ph1/2 VX-880 Trial Placed on Clinical Hold

Two cardiometabolic-related news items have recently been observed: Beta Bionics presented results from its insulin-only bionic pancreas pivotal trial at ATTD 2022 (press release); and Vertex issued a press release detailing updates to its Ph1/2 VX-880 trial, including that FDA has placed a clinical hold on the study (press release). 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.

Novo, Dexcom, AZ, Sanofi, Biocon, and Teladoc Q1 ’22 Earnings Updates

A series of cardiometabolic-related news items have been observed: Novo (press release; slides), Dexcom (press release; slides), AZ (press release; slides), Sanofi (press release; slides), Biocon (press release), and Teladoc (press release; slides) hosted their respective Q1 ’22 earnings calls. Below, FENIX provides highlights and insights from the respective 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.

Novo Reports First QW Basal Insulin Icodec Ph3 Data

Novo announced topline results from its first QW basal insulin icodec Ph3 program (ONWARDS 2) comparing icodec to degludec in 526 patients with T2DM switching from QD insulin. Data demonstrated a statistically superior 0.93% reduction in A1C with icodec vs. 0.71% reduction with degludec. Below, FENIX provides thoughts into ONWARDS 2 icodec results.

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.

Did Lilly Cure Obesity? SURMOUNT-1 Topline Results; Q1 ‘22 Earnings Updates

Lilly hosted its Q1 ’22 earnings call (press release; slides) and provided updates across its CVRM portfolio. Prior to the earnings call, Lilly announced highly positive topline results from the first Ph3 tirzepatide obesity study (SURMOUNT-1) which demonstrated up to 22.5% weight loss (press release). In prepared remarks, management briefly discussed other CVRM-related topics, including regulatory approvals of EMPEROR-Preserved (previous FENIX insight), the initiation of its QW insulin Ph3 program (QWINT-3; previous FENIX insight), and early termination of EMPA-KIDNEY (previous FENIX insight). Importantly, Lilly confirmed it purchased a PRV in Q1 ’22. Below are 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.

ATTD 2022 Key Press Releases (April 27); Abbott, Ypsomed, and CamDiab to develop AID System

On the first day of ATTD 2022, a series of diabetes-related press releases have been observed from Insulet, Welldoc, and Tandem. Separate from the conference, Abbott, Ypsomed, and CamDiab announced a partnership for the development of an AID system. 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.