Category Archives: Other

Finerenone Approved in US as “Kerendia”

Bayer announced the FDA approval of 10mg and 20mg finerenone, branded as “Kerendia,” to reduce the risk of sustained eGFR decline, end-stage kidney disease, CV death, non-fatal MI, and hHF in adults with CKD associated with T2DM (see logo below). The approval of finerenone is based on the positive results of the FIDELIO-DKD study and the timing comes in-line with FENIX’s projection. Recall, results from FIDELIO-DKD were presented at Kidney Week in October 2020 and demonstrated an 18% RRR in the primary composite endpoint. Finerenone is currently under review in the EU, China, and multiple other countries worldwide. FENIX will conduct a full label analysis of finerenone in the coming days once the label is available.

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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Roxadustat Adcom May Be Impacted By Roster Changes

Ahead of the AstraZeneca/Fibrogen roxadustat FDA adcom on July 15, 2021, FENIX has identified a recent event that may be impactful to the overall result. More specifically, the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) roster has been updated with three committee member terms ending and two new members being added. Below, FENIX provides thoughts on how the updated roster could favor/disfavor AZ/Fibrogen.

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.

Novartis Resubmits Inclisiran NDA; Provention Bio Receives CRL for Teplizumab

Two cardiometabolic-related news items have been observed: Novartis announced the inclisiran NDA has been resubmitted to FDA and Provention Bio announced it received a CRL from FDA for the teplizumab BLA citing the need for additional data regarding PK comparability. Of note, the Provention Bio CRL did not cite any clinical deficiencies related to the efficacy and safety data packages and confirmed the acceptability of the proposed proprietary name for teplizumab, Tzield. 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.

Why Lilly Will Terminate GGG; Lilly ADA 2021 Investor Update

Lilly hosted an ADA investor event in which the company covered tirzepatide, tri-agonist GGG, QW basal insulin, oral incretins, and a summary slide of Lilly’s CVRM R&D portfolio. Below, FENIX provides highlights and insights from the event, including why GGG won’t progress beyond Ph2.

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.

ADA 2021 Key Press Releases (June 29)

On the final day of ADA 2021, six cardiometabolic-related press releases were observed from Novo/Walmart, Lilly, Lexicon, Hanmi, Dario, and Adocia. Below, FENIX provides context and analysis for the announcements, including an RAI price-ranking following the Novo/Walmart partnership for ReliOn NovoLog.

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 Dual Agonist T2DM Intentions Disclosed at ADA Investor Event; Lilly Could Pursue Hypo Claim vs. Degludec in QW Basal Ph3

Two cardiometabolic presentations from Novo Nordisk and Lilly have recently been observed: Novo hosted an ADA investor event and Lilly presented CGM data from the Ph2 QW insulin trial at ADA 2021. Below, FENIX provides insight on what Novo really hopes to accomplish vs. tirzepatide, and how Lilly may pursue a hypo reduction claim vs. degludec for its QW basal insulin.

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.

ADA 2021 Key Press Releases (June 25)

On the first day of ADA 2021, eleven cardiometabolic-related news items were observed from Medtronic, Lilly, AstraZeneca, CeQur, Abbott, Onduo, Glooko, Mannkind, ViaCyte, Glytec, and Akero. Below, FENIX provides context and analysis for the announcements.

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.

Imeglimin Approved in Japan as “Twymeeg”; Diamyd Q1 ’21 Business Update

Two cardiometabolic-related news items have been observed: Poxel and Sumitomo Dainippon Pharma announced Japanese approval of 500mg oral imeglimin, branded as “Twymeeg,” for the treatment of T2DM; and Diamyd announced its quarterly report for Q3 ’21. 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.

Bigfoot Unity Video Highlights Connected System; Celon’s Next-gen GPR40 Enters Ph2 Development

Two diabetes-related items have been observed: Bigfoot recently highlighted its Bigfoot Unity system ahead of the impending launch; and Celon Pharma announced it filed for approval to begin a Ph2 trial investigating a second-generation oral QD GPR40 agonist, referred to as CPL’280, for the treatment of T2DM. Below, FENIX provides highlights from the respective items as well as thoughts on Celon’s decision to advance its GPR40 agonist despite the previous failed efforts from competitors (e.g. Lilly, Amgen, etc.).

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 to Expand Basal Insulin Titration App to EU and Asia; Novo Partners for Oral Protein Delivery; Closes $100M Series F

A series of cardiometabolic news items have been observed: Novo Nordisk (in partnership with Amalgam Rx) plans to expand the availability of the Dose Check basal insulin titration app in Europe and Asia (press release); Novo partners with Lumen Bioscience for oral protein manufacturing and delivery (press release); Fractyl announced the closing of a $100M Series F (press release). 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.