Tag Archives: Zealand

New Non-invasive CGM Startup Raises $11.7M in Series B; Zealand, Mannkind, and Metacrine Q2 ’21 Earnings Updates; Integrity Applications Reverse Stock Split

A series of cardiometabolic-related news items have been observed: Hagar announced it has raised $11.7M in Series B financing for the clinical development of a non-invasive CGM; Zealand, Mannkind, and Metacrine hosted their Q2 ’21 earnings calls; and Integrity Applications announced it has implemented a 1-for-13 reverse stock split. 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.

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ATTD 2021 Key Press Releases (June 2)

With the start of the ATTD 2021 conference, a series of cardiometabolic-related press releases have been observed from BI/Zealand, Medtronic, Metacrine, and Obatala Sciences. 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.

Zealand Q1 ’21 Earnings Update

Zealand hosted its Q1 ’21 earnings call and provided updates to its business, including the impending US launch of Zegalogue in mid- to late-June as well as other pipeline updates. 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.

Zealand Ph3 RTU Dasiglucagon Results Published in Diabetes Care; Genfit Launches NASHnext Diagnostic Test

Two cardiometabolic-related news items have been observed: Zealand announced the results of its Ph3 trial evaluating its ready-to-use (RTU) dasiglucagon for the treatment of severe hypoglycemia in adults with diabetes were published in Diabetes Care; and Genfit announced the US and Canadian launches of its non-invasive diagnostic test for NASH, called NASHnext. 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.

New BI/Zealand Trials in NASH and Obesity; vTv Granted BTD for TTP399; Jaguar Gene Therapy $139M Series B; CeQur $115M Series C5; Nemaura Launches BEATdiabetes App and proBEAT CGM Pilot; BioCorp/Roche Launch Mallya in France; Amarin CEO to Retire

A series of cardiometabolic-related new items have recently been observed from Boehringer Ingelheim/Zealand, vTv Therapeutics, Jaguar Gene Therapy, CeQur, Nemaura Medical, Biocorp/Roche, and Amarin. 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.

Zegalogue (Dasiglucagon) Label Analysis

Zealand recently announced its dasiglucagon hypoglycemia rescue product, branded as “Zegalogue,” received FDA approval (view label; previous FENIX insight). Following the approval, Zealand hosted an investor webcast to provide additional details surrounding the commercialization of Zegalogue (view slides). Below, FENIX has conducted a Zegalogue label analysis in the context of Lilly’s Baqsimi and Xeris’s Gvoke.

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.

Zealand’s Dasiglucagon Approved; March 22-25 CHMP Agenda; Fractyl Enrolls First Patient in T2DM Study; Twist Bioscience Announces Positive Preclinical Data

A series of cardiometabolic-related news items have been observed: Zealand’s dasiglucagon has been approved in the US as “Zegalogue” for the treatment of severe hypoglycemia in patients 6 years of age and older; the CHMP agenda for this month’s meeting (March 22-25, 2021) has been released; Fractyl announced the first patient has been enrolled in a pivotal trial of Revita DMR; and Twist Bioscience announced positive preclinical data in which its library identified GLP-1R antibodies that demonstrated glucose control. Below, FENIX provides highlights and insights from the respective news items, including thoughts on two potential generic sitagliptin products on the CHMP agenda.

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.

Zealand Q4 ’20 Earnings Update; Nemaura Submits for sugarBEAT Reimbursement in Germany

Two diabetes-related news items have been observed: Zealand hosted its Q4 and FY 2020 earnings call (press release; slides); and Nemaura announced it has submitted sugarBEAT for reimbursement in Germany. In case you missed it, FENIX provided coverage of Zealand’s R&D Day on March 5, 2021 (previous FENIX insight). Below FENIX provides highlights and insights from the respective news items, including an analysis on whether Beta Bionics, who is partnered with Zealand for dasiglucagon, would launch the insulin-only iLet configuration or if it would wait for the bi-hormonal system.

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.

Zealand R&D Day Highlights

Zealand hosted its R&D day (view slides) and provided updates to its diabetes and obesity development programs. Specifically, Zealand highlighted the near-term US approval and launch of the HypoPal glucagon rescue pen, medium-term development of the bi-hormonal iLet pump with Beta Bionics, and long-term research activities in obesity (e.g. amylin analog and GIP agonist). Below, FENIX provides highlights and insights from the events.

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.

Zealand and Dario Q3 ’20 Earnings Updates; Tidepool Completes Loop Human Factors Validation Study

A series of diabetes-related news items have been observed: Zealand hosted its Q3 ’20 earnings call; DarioHealth hosted its Q3 ’20 earnings call; and Tidepool announced the completion of its human factors validation study for its automated insulin dosing app, Tidepool Loop. 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.