Category Archives: Topics

Summary of Tirzepatide SURPASS Ph3 Event

Today, Lilly hosted a webcast presenting an overview of the Ph3 tirzepatide SURPASS program. Of note, Lilly highlighted that topline data from SURPASS-1 is anticipated in mid-December 2020 with US/EU filing in late 2021/early 2022. Below, FENIX provides highlights from the call as well as insights into the incretin dynamics in the T2DM space.

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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Imeglimin Ph3 US and EU Development Discontinued by Metavant; Poxel Seeks Other Options

Poxel announced that Metavant, its US and EU development partner for Imeglimin, has decided not to move Imeglimin into Ph3 trials. Recall, in Poxel’s Q3 ’20 earnings update, Poxel disclosed that Metavant was in discussions with FDA regarding the Imeglimin Ph3 program in patients with T2DM and stage 3b or 4 CKD (previous FENIX insight). Below, FENIX provides thoughts on the future of Imeglimin in Western markets.

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 Partners with Ypsomed for AID System; Tidepool Lays Off 40% of Staff

Two diabetes-related news items have been observed: Lilly and Ypsomed announced a partnership for the commercialization of Ypsomed’s AID system and Tidepool announced layoffs accounting for 40% of their staff. Below, FENIX provides highlights and insights for the respective news items, including thoughts on if the Lilly/Ypsomed partnership may be an admission from Lilly that its AID development is behind expectations and how the material experience of Mike Mason may have contributed to this deal getting done.

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.

Lexicon @ Stifel; First Presentation Since SOLOIST and SCORED Results

Lexicon participated in the 2020 Stifel Virtual Healthcare Conference and provided brief updates on its sotagliflozin strategy following the data readout from SOLOIST and SCORED. In case you missed it, here is a link to FENIX’s initial thoughts on the data. Below, FENIX provides highlights from Lexicon senior management’s commentary as well as an updated perspective and implications to sotagliflozin’s commercial prospects.

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.

EMPA-REG OUTCOME Post Hoc Analysis; Abbott Sponsors ADA Health Equity Initiative; Nemaura Launches BEAT Platform and Updated Company Website Ahead of US proBEAT Launch

Three diabetes-related news items have been observed: BI and Lilly announced results from a post hoc analysis of the EMPA-REG OUTCOME trial; Abbott and ADA announced Abbott is the first anchor sponsor of the Health Equity Now (HEN) platform with a $5M contribution towards addressing health disparities for PWD; and Nemaura Medical announced the relaunch of its company website and the launch of its BEAT diabetes website. 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.

SUSTAIN FORTE Topline Results: Ozempic 2.0mg Doubles the Dose but not the Efficacy

Novo Nordisk announced topline results from its high-dose injectable semaglutide Ph3 study, SUSTAIN FORTE. The study demonstrated a -2.2% reduction in A1C and -6.9kg weight loss with 2.0mg semaglutide according to the trial product estimand (e.g. per-protocol analysis). Below, FENIX provides a SUSTAIN FORTE comparative analysis, including thoughts on high-dose Ozempic in the context of high-dose Rybelsus, high-dose Trulicity, and tirzepatide, as well as updated perspective on the regulatory timing for Novo’s sema obesity submission with its PRV.

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.

Lexicon Wins Big with SOLOIST and SCORED

Late yesterday, results from the sotagliflozin CVOTs (SOLOIST-WHF and SCORED) were presented at the AHA 2020 conference (view press release) and simultaneously published in the NEJM (SOLOIST-WHF publication and SCORED publication). Somewhat surprisingly, both trials demonstrated highly statistically significant CV benefits despite the fact that they were closed early due to financial and strategic reasons (previous FENIX insight). Below, FENIX provides an overview of the SOLOIST and SCORED results as well as implications to the SGLT2i class and beyond.

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.

FDA Accepts IND for Lilly/Dicerna Cardiometabolic Asset; Gilead/Novo Announce Ph2 PoC NASH Results; Biocorp Launches Mallya in Europe; Nemaura Q3 ’20 Earnings Update; Diabeloop Partners for AID System in Japan

A series of diabetes-related news items have been observed: Dicerna announced FDA accepted Lilly’s IND application for a novel, unknown cardiometabolic asset, LY3561774; Gilead and Novo Nordisk announced positive results from a Ph2 PoC trial evaluating Novo’s semaglutide in combination with Gilead’s investigational FXR agonist and/or its ACC inhibitor for the treatment of NASH; Biocorp announced the launch of its Mallya insulin connected cap in Europe via a partnership with cgmDiabet; Nemaura Medical announced its CY Q3 ’20 (FY Q2 ’21) earnings; and Diabeloop and Terumo Corporation announced a partnership for the joint development of an AID system and exclusive distribution rights in Japan. Below, FENIX provides highlights and insight for the respective news items including curious questions on the Dicerna target split between Lilly-Novo and semaglutide Ph3 combos in NASH.

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.

Omecamtiv Misses on Primary Outcome Components, Hits on LVEF <28% Subgroup; GALACTIC-HF @ AHA 2020

Full results from the GALACTIC-HF trial were presented during the late-breaking clinical trial session at the 2020 AHA conference (view Cytokinetics press release) and simultaneously published in the NEJM (view publication here). Cytokinetics hosted a subsequent call with investors to discuss the trial results. Below, FENIX provides thoughts on the GALACTIC-HF results in the context of the HF market.

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.