Tag Archives: finerenone

Bigfoot Unity Receives 510(k) Clearance; Bayer’s FIGARO-DKD Meets Primary Endpoint; Viatris Q1 ’21 Earnings Update; Novo Insulin Product Samples Recalled

A series of cardiometabolic-related news items have been observed: Bigfoot announced FDA granted 510(k) clearance for its Bigfoot Unity Diabetes Management System which features connected smart pen caps integrated with Abbott’s Libre 2 CGM; Bayer announced the Ph3 FIGARO-DKD CVOT evaluating finerenone in ~7,400 adults with CKD and T2DM has met its primary endpoint; Viatris hosted its Q1 ’21 earnings call; and Novo Nordisk announced a voluntary recall of 1,468 Levemir, Tresiba, Fiasp, Novolog, and Xultophy product samples due to improper storage temperature conditions. 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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Thoughts on Bayer’s 2021 Capital Markets Day

Earlier this week, Bayer hosted its 2021 Capital Markets Day and provided a company-wide update (view transforming pharma slides; view pharma R&D slides). Bayer’s President of Pharmaceuticals, Stefan Oelrich, provided a strategic update on the business, insights into the ongoing transformation, and the path for creating value through 2024. Unsurprisingly, finerenone and Verquvo (vericiguat) were highlighted as key parts of the company’s return-to-growth strategy in the context of the impending Xarelto and Eylea LOEs. Below, FENIX provides highlights and insights from the Bayer 2021 CMD event related to CVRM.

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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Novo Invests in Danish Facility for Oral Sema Production; MNKD, PRVB, ICPT, BAYRY, and IONS Q4 ’20 Earnings Updates

A series of cardiometabolic-related news items have been observed: Novo Nordisk announced plans to invest 500M DKK (~82M USD) to expand its oral tablet production facilities in Måløv, Denmark; and Mannkind, Provention Bio, Intercept, Bayer, and Ionis hosted their Q4 and FY ’20 earnings call. 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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Purchase Blast$599.00

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EMPEROR-Reduced Filed with EMA; November 2020 CHMP Agenda; Bayer Submits Finerenone to FDA and EMA; Xeris Q3 ’20 Earnings Update

A series of diabetes-related news items have been observed: the November 2020 CHMP agenda has been released and includes one notable item, EMPEROR-Reduced; Bayer announced it has filed finerenone for patients with CKD and T2DM with the FDA and EMA; and Xeris hosted its Q3 ’20 earnings call. Below, FENIX provides highlights and insights from the respective news items, including thoughts on the potentially curious EMPEROR-Reduced appearance on the November 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.

FIDELIO Demonstrates 18% RRR; DAPA-CKD and EMPEROR-Reduced Sub-Analyses

On the second day of Kidney Week 2020, three notable data sets were released: Bayer’s FIDELIO-DKD study demonstrated an 18% RRR in the primary composite endpoint (view press release; view NEJM publication); AstraZeneca presented a DAPA-CKD sub-analysis that demonstrated a reduction in the composite endpoint irrespective of the underlying CKD cause (view press release); BI/Lilly presented an EMPEROR-Reduced sub-analysis showing no difference in CV/renal outcomes regardless of baseline CKD (view press release). Below, FENIX provides highlights and implications of the data with a particular focus on FIDELIO.

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.

Sotagliflozin, Finerenone, and Omecamtiv CVOTs @ AHA 2020

The AHA 2020 late-breaking abstract titles have been published and include the sotagliflozin (SOLOIST-WHF and SCORED), finerenone (FIDELIO-DKD), and omecamtiv mecarbil (GALACTIC-HF) CVOTs (view all AHA late-breaking topics here). Recall, Bayer announced positive topline results from FIDELIO-DKD in July 2020 (previous FENIX insight). Lexicon has not released any topline results from the SOLOIST-WHF and SCORED trials, which were closed out early following the Sanofi partnership dissolution (previous FENIX insight). As such, the SCORED and SOLOIST-WHF results are highly anticipated.

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.

Bayer Reports Finerenone T2DM DKD Renal Outcomes Trial Topline Results (FIDELIO-DKD) ; EMPEROR-Reduced at ESC 2020

Bayer announced positive topline results from its Ph3 FIDELIO-DKD trial evaluating finerenone in T2DM with CKD. Finerenone demonstrated a delayed progression to the primary composite endpoint (onset of kidney failure, sustained decrease of eGFR ≥ 40% from baseline over at least 4 weeks, or renal death). The specific risk reduction was not disclosed. Below, FENIX provides thoughts on the FIDELIO-DKD results including a curious observation that the press release did not mention anything about safety in the trial.

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.