Category Archives: Topics

FENIX Analysis: SGLT2i HF CVOTs and Stopping Early Scenarios

Currently, there are multiple ongoing, label-enabling HF CVOTs in the SGLT2i class for Jardiance, Farxiga, and Zynquista (sotagliflozin), along with other studies exploring surrogate endpoints, biomarkers, and mechanisms of action. FENIX has created a tale-of-the-tape summary of the SGLT2i HF CVOTs along with a projected timeline for filings and launches. In summary, it is believed that AZ’s DAPA-HF CVOT has a high probability of stopping early for overwhelming efficacy and thus creating a priority review scenario to leap AZ ahead of BI/LLY by 6-12 months in this important LCM opportunity. Below is a summary of the rationale and hypothesis comparing the different development approaches by SGLT2i sponsors to improve clinical outcomes in HF patients.

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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Novo’s oral semaglutide beats Jardiance in PIONEER 2

Novo Nordisk has announced topline results from the Ph3 PIONEER 2 study comparing oral semaglutide to BI/Lilly’s Jardiance. Interestingly, this is the second oral semaglutide trial to have topline results (PIONEER 1 FENIX insight); and in each case, Novo has only disclosed on-treatment results. Below, FENIX provides insight into PIONEER 2 results and the impact on oral semaglutide commercialization.

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.

Zealand completes 2nd Ph3 pivotal rescue trial for dasiglucagon

Zealand reported completion of the second Ph3 dasiglucagon pivotal trial for the treatment of severe hypoglycemia, slightly ahead of previous guidance. Results of the trial, which included 156 T1DM subjects, are now anticipated in Q3 2018.

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.

Xeris files for $75M IPO

Xeris Pharmaceuticals has filed with the SEC for a $75M IPO under the ticker XERS. Of note, the S1 IPO registration document states FDA filing of G-Pen is anticipated in Q3 ’18, which is later than previously stated by Xeris (late Q2 ’18).

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.

Beta Bionics to initiate in-home IDE for insulin-only AP system

Beta Bionics announced it received IDE approval from FDA to initiate in-home trials of the iLet insulin-only closed loop system. According to the press release, Beta Bionics plans to initiate pivotal studies in 2019 with launch of the first commercial device in 2020.

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 Q1 ‘18 Earnings Updates

AZ hosted their Q1 ’18 earnings call and briefly discussed their diabetes portfolio, with a particular focus on Farxiga, including H2 ‘18 readout of the DECLARE CVOT and planned H2 ’18 US filing in T1DM.

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 Q1 ‘18 Earnings Update

Zealand hosted its Q1 ‘18 earnings call and provided updates on its diabetes portfolio including dasiglucagon. Additionally, Zealand discussed the potential of a priority review voucher (PRV) for dasiglucagon in congenital hyperinsulinism (CHI).

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 Novo PRV importance to oral semaglutide

During Novo’s Q1 ’18 London earnings webcast, senior management discussed potential scenarios surrounding the recently-purchased priority review voucher (PRV), including its use for either oral semaglutide or a semaglutide obesity indication. Below, FENIX provides its thoughts on how the PRV serves as insurance to a successful launch for oral semaglutide, as well as some anticipated triggers for its usage.

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.

Dexcom Q1 ’18 Earnings Update

Dexcom hosted its Q1 ’18 earnings call and provided updates on its recently approved G6 CGM as well as pipeline initiatives. Of note, Dexcom has initiated a limited launch of the G6 CGM and it plans a larger rollout prior to ADA in June 2018. Below are highlights 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.

Novo Nordisk Q1 ’18 Earnings Update

Novo hosted its Q1 ’18 earnings call (press release) and provided updates on its marketed and pipeline diabetes products. Of note, Novo discussed the relaunch of Tresiba based on the recent DEVOTE label update. Furthermore, Novo disclosed plans to initiate Ph2 for its QW basal insulin (LAI287) by YE ’18. Below are highlights 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.