Category Archives: Topics

Xeris to Acquire Strongbridge; NGM Bio Discontinues NASH Program; BI Selects NASH Drug Candidate From Dicerna

A series of cardiometabolic news items have been observed: Xeris and Strongbridge announced they have entered into a definitive agreement under which Xeris will acquire Strongbridge for stock and contingent value rights; NGM Bio announced the discontinuation of its NASH program following topline results from the Ph2b trial; and Dicerna announced BI has accepted a GalXC RNAi candidate, referred to as DCR-LIV2, for advancement under its existing agreement. 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.

SURPASS-4 Data Continue to Impress; Arecor and Lilly Partnership

Two diabetes-related news items have been observed: Lilly announced positive topline results from the Ph3 SURPASS-4 trial comparing tirzepatide to insulin glargine in patients with T2DM and an increased CV risk; and Arecor announced it has signed a formulation study partnership with Lilly, in which Arecor will use its proprietary tech platform Arestat for “one of Lilly’s proprietary products intended for self-administration.” 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.

Roche Launches Smartphone-controlled Pump; Metronom Enters CGM JV in China; FDA Draft Guidance on T2DM Glycemic Control Devices; Dario Q1 ’21 Earnings Update; New Ascensia BGM Portal; Metacrine Ph2 NASH Trial

A series of cardiometabolic news items have been observed: Roche announced the launch of its mySugr Pump Control smartphone app; Dinova Medtech and Metronom Health have created a joint venture in China for CGM development and commercialization; FDA issued a draft guidance on medical devices intended to improve glycemic control in T2DM; Dario hosted its Q1 ’21 earnings call; Ascensia announced the launch of the new “GlucoContro.online” patient and provider portal for diabetes management and analytics; and Metacrine has enrolled the first 60 patients in its MET642 Ph2a NASH trial. 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.

Novartis Post-ACC CV Investor Event Highlights; Inclisiran Expected as Class 2 Review

Today, Novartis hosted a post-ACC cardiovascular investor event in which it provided updates across its business, including Entresto, Leqvio (inclisiran), and pelacarsen (Lp(a)). Below, FENIX provides highlights and insights from the event including thoughts on inclisiran receiving a Class 2 review.

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’s Ph2 Ziltivekimab Data @ ACC 2021; Sheldon Koenig Takes Over as Esperion CEO; New T1DM Treatment from Neurodon

A series of cardiometabolic news items have been observed: full results from Novo Nordisk’s Ph2 ziltivekimab were presented at ACC 2021; Sheldon Koenig was appointed as Esperion’s new President and CEO; and Neurodon is initiating IND-enabling studies for its novel T1DM therapeutic. 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.

EMPEROR-Reduced, DAPA-CKD, and Vericiguat Opinions?; May 17-20 CHMP Agenda

The CHMP agenda for this month (May 17-20) has been released, and it includes three notable items, EMPEROR-Reduced, DAPA-CKD, and vericiguat, as well as several other cardiometabolic-related entries. 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.

Senseonics, Xeris, Mannkind, and Bayer Q1 ’21 Earnings Updates

Senseonics, Xeris, Mannkind, and Bayer hosted their Q1 ’21 earnings calls and provided updates to their respective businesses. Below, FENIX provides highlights and insights from the 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.

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.

DAPA-CKD Label Analysis; Farxiga Websites Updated

In late April 2021, FDA approved Farxiga for the treatment of CKD. The approval was based on results from the DAPA-CKD Ph3 trial which demonstrated a highly impressive 39% RRR in the primary composite endpoint (sustained ≥50% decline in eGFR, ESKD, renal death, or CV death; previous FENIX insight). Below, FENIX provides thoughts on the new Farxiga CKD indication, including read-through to finerenone, sotagliflozin, Jardiance and the rest of the SGLT2i class.

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 Obesity Ph2 GGG Tri-agonist Trial; Novo QW Icodec Ph3 T2DM; Sigilon Q1 ’21 Earnings Update

A series of cardiometabolic-related news items have been observed: a CT.gov record for a Ph2 Lilly-sponsored trial investigating QW LY3437943 (GGG tri-agonist) in obesity has been observed; a CT.gov record for Novo Nordisk’s Ph3 QW insulin icodec T2DM trial (ONWARDS 4) has been observed; and Sigilon announced its Q1 ’21 earnings, though it did not provide a development update on SIG-002 nor did it host an associated webcast. 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.