Tag Archives: AZ

AZ Provides Additional DAPA-CKD Commentary During Post-Results Investor Call

Following the DAPA-CKD results, which were presented at ESC 2020 on August 30 (previous FENIX insight), AZ hosted a call with investors (view slides here). Beyond reviewing the DAPA-CKD results, AZ senior management and DAPA-CKD investigators provided commentary on the trial results and the new Farxiga market potential. Below, FENIX provides highlights from the investor call as well as additional perspective on the impact of DAPA-CKD.

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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One Drop Launches New Membership Program; AZ Partners with RenalytixAI for Chronic Disease Precision Medicine

Two diabetes-related news items have been observed: yesterday, One Drop announced it has launched a new “Digital Membership” platform and AstraZeneca has entered into a partnership with RenalytixAI for “precision medicine strategies” in CV, renal, and metabolic diseases. Below, FENIX provides highlights and insights from the respective news items, including thoughts on why One Drop’s Digital Membership may be an admission that its current diabetes solution and commercial infrastructure is lacking.

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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Livongo to Merge with Teladoc; AZ Partners for HF Diagnostic; ViaCyte Partners with Gore for Novel Membrane Development; Teva Q2 ’20 Earnings Update

A series of diabetes-related news items have been observed: Livongo and Teladoc Health announced they have entered into a definitive merger agreement; Eko announced it entered into a global partnership with AstraZeneca for a heart failure diagnostic tool; ViaCyte and Gore announced an agreement to further develop ViaCyte’s Encaptra Cell Delivery System to facilitate stem cell-derived islet replacement (press release); and Teva hosted its Q2 ’20 earnings call (press release; slides). Below, FENIX provides highlights for the respective news items including thoughts on the Livongo+Teladoc merger and insight into the AZ diagnostic partnership as a lead generation tool for Farxiga.

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 Positive Topline Results; AZ Discontinues its GLP-1RA Small Molecule; Lexicon to Reorganize; Lilly, AZ, and Lexicon Q2 ’20 Earnings Updates

Lilly (press release; slides), AstraZeneca (press release; slides), and Lexicon (press release; slides link unavailable) hosted their respective earnings calls. Importantly, BI/Lilly announced positive topline results from the EMPEROR-Reduced outcomes trial in HFrEF patients with and without T2DM, AZ discontinued its small molecule GLP-1RA (MEDI7219), and Lexicon is restructuring its business to shift focus toward R&D. Below, FENIX provides insights into the EMPEROR-Reduced results in the context of the evolving SGLT2i HF market as well as thoughts on how Lexicon’s restructuring could be an indicator for the sotagliflozin CVOT results.

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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DAPA-CKD Hits on All Endpoints

AstraZeneca announced positive topline results from the Ph3 DAPA-CKD trial evaluating the effect of dapagliflozin on renal and CV outcomes in CKD patients with and without T2DM (view CT.gov record). According to the press release, Farxiga met all primary and secondary endpoints including all-cause mortality; however, no specific data was provided. Recall, DAPA-CKD was stopped at the end of March ~8 months early due to overwhelming efficacy (previous FENIX insight). Below, FENIX provides thoughts on the topline results ahead of the July 30 earnings call and in the context of the Invokana CREDENCE renal protection indication, the impending results from BI/Lilly’s EMPA-KIDNEY study, and Bayer’s FIDELIO-DKD outcomes trial for finerenone.

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.

AZ CVRM Q1 ’20 Earnings Update

AstraZeneca hosted its Q1 ’20 earnings call and briefly discussed its diabetes business including the recent topline data readout from DAPA-CKD, which stopped early for overwhelming efficacy. Interestingly, AZ said it does not project DAPA-CKD filing acceptance until 2021. Below, FENIX provides highlights and insights from the call, including thoughts on why the DAPA-CKD submission is later than expected.

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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DAPA-CKD Stopped Early for Overwhelming Efficacy

AstraZeneca announced that an independent data monitoring committee (DMC) has recommended stopping the DAPA-CKD study early due to overwhelming efficacy. According to CT.gov, the early trial closeout is ~8 months ahead of the full trial completion date (initially scheduled to complete in November 2020). Below, FENIX provides thoughts on DAPA-CKD in the context of Janssen’s CREDENCE, which was also stopped early, as well as potential read through to BI/Lilly and Lexicon.

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.

AZ Partners with Silence Therapeutics for siRNA Targeting; AZ Leverages BrightInsight for Digital Platform

AstraZeneca has entered into two new collaborations: Silence Therapeutics and BrightInsight. The partnership with Silence Therapeutics covers the discovery and development of novel siRNA targeting of CV, renal, metabolic, and respiratory diseases. Separately, the collaboration with BrightInsight is intended to support AZ’s digital health solutions for the “chronic disease management space”. Below, FENIX provides highlights and insights related to the respective partnerships, including Silence’s accompanying investor 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.

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Purchase Blast$599.00

You can read the article’s full content online after purchase.

AstraZeneca Q4 ’19 Earnings Update

AstraZeneca hosted its Q4 ’19 and FY ’19 earnings call and provided updates to its diabetes business. Of note, AZ disclosed it received Fast Track designation for the development of cotadutide (dual GLP-1/GCG agonist) for the treatment of NASH. 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.

Farxiga DAPA-HF receives priority review; Fiasp pediatric approval in US; MannKind launching in Brazil

A series of diabetes-related news items were observed today from AstraZeneca, Novo Nordisk, and MannKind. AZ announced FDA filing acceptance and granting of priority review for the Farxiga DAPA-HF sNDA. According to AZ, the PDUFA date is in Q2 2020. Additionally, Novo announced US approval of Fiasp for pediatric populations. Further, MannKind announced that it has received approval of the proposed price of Afrezza in Brazil, and intends to commence marketing and distribution the week of January 13, 2020. Below, FENIX provides context and insights regarding these 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.