Category Archives: SGLT2i

J&J Q1 ’20 Earnings Update

Johnson & Johnson hosted their Q1 ’20 earnings call and briefly touched on the Invokana franchise. Unsurprisingly, much of the call was focused on the impact of COVID-19, which led J&J to lower its 2020 guidance. Below, FENIX provides diabetes-related highlights and insight 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.

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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.

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Purchase Blast$599.00

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

CRL for Empa 2.5mg in T1DM

BI/Lilly announced late Friday that the FDA has issued a CRL for the T1DM sNDA of empagliflozin 2.5 mg (press release). Of note, the CRL indicates that “the FDA is unable to approve the application in its current form.” Below, FENIX provides thoughts on the empa T1DM CRL in the context of other SGLTi T1DM initiatives.

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.

Thoughts on Lexicon Closing Its Sota CVOTs

Yesterday, Lexicon announced the early close out of its sotagliflozin CVOTs, SCORED and SOLOIST, mainly due to operational challenges with COVID-19 and the low likelihood of finding a commercialization partner (press release). Below, FENIX provides highlights and insights surrounding this update, including the potential generalization to BI/Lilly’s EMPEROR HF studies, and larger thoughts on Lexicon’s pivot away from sotagliflozin.

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.

Zyquista T1DM CRL stands (Lexicon Q4 ’19 Earnings Update); Jardiance CKD Fast Track Designation

Lexicon hosted its Q4 ’19 earnings call (press release) and provided brief updates on the Zyquista T1DM CRL appeal as well as the T2DM Ph3 development program. Additionally, Lilly announced the FDA’s fast track designation to Jardiance in chronic kidney disease (press release). Of note, CDER reaffirmed the FDA’s decision on the Zyquista T1DM CRL, stating the NDA application in T1DM could not be approved in its current form. Below are the key highlights and insights from Lexicon’s earnings call as well as the Jardiance CKD fast track designation, especially in the context of other ongoing renal outcomes trials.

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.

New dapa HF study (DICTATE-AHF) in T2DM patients with acute decompensated heart failure

Last week, a Ph3 dapagliflozin trial (DICTATE-AHF) in T2DM patients with acute decompensated heart failure (ADHF) was observed on CT.gov. Of note, the study is assessing the decongesting effects of dapagliflozin and protocolized diuretic therapy in ADHF patients. Below, FENIX provides thoughts on this new trial in the context of other SGLT2 HF trials and what it could mean for AZ.

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.

CREDENCE CHMP Opinion This Week? DAPA-HF Filed with EMA; CHMP Agenda February 24-27

The CHMP agenda for this month’s meeting (February 24-27) has been released, and it includes two notable items (CREDENCE opinion and DAPA-HF filing) as well as some others. Below, FENIX provides diabetes-related highlights and insights from the February 2020 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.

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.

Merck Keeps Januvia As it Spins Off Other Legacy Brands

In conjunction with Merck’s Q4 and FY 2019 earnings call, the company announced plans to create a spin-off company with assets from Merck’s Women’s Health, Legacy Brands, and Biosimilars business. There was no mention of Merck/Pfizer’s Steglatro franchise on the call. Below, FENIX provides highlights from the Merck earnings call as well as insights as to why Januvia is not included in the spinoff company.

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.

Thoughts on New CVS Program to Eliminate Diabetes Drug OOP Costs

CVS Health recently announced a new program called “RxZERO,” which is said to completely eliminate all out of pocket costs (OOP) for diabetes prescription drugs. According to the press release, RxZERO will provide the benefit to members “without raising costs for the plan sponsor or increasing premiums or deductibles for all plan members.” Below, FENIX provides thoughts on the RxZERO program in the context of the ongoing drug pricing debate in the US.

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.