Category Archives: Topics

Libre 2 Launched in the US; Libre 2 App Not Yet Available

Abbott has officially launched its Libre 2 CGM in the US, although the website (view here) has not yet been updated at the time of this publication. Of note, Abbott disclosed the Libre 2 App remains under review by FDA, suggesting the user must purchase the dedicated reader. Below, FENIX provides an excerpt from the Libre 2 launch email as well as brief thoughts on how the lack of a Libre 2 App could impact the initial launch.

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.

Sanofi Q2 ’20 Earnings Update

Sanofi hosted its Q2 ’20 earnings call (press release; slides) and provided a brief update to its diabetes business in the context of the continued decline in glargine revenue. Unsurprisingly, the vast majority of the call was dedicated to Dupixent performance and Sanofi’s preparation for the upcoming flu season. Below, FENIX provides a financial summary of the diabetes portfolio 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.

Dexcom and Pfizer Q2 ’20 Earnings Updates

Dexcom (press release; slides) and Pfizer (press release; slides) hosted their Q2 ’20 earnings calls and provided updates to their respective diabetes businesses. Despite COVID-19, Dexcom posted a +34% YOY performance and disclosed that T2DM patients now make up ~20% of its total installed base. Below, FENIX provides highlights and insights from the calls.

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.

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.

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.

Nemaura Set to Acquire Healthimation

Nemaura Medical announced it has entered into a letter of intent with Healthimation “relating to a possible acquisition of the Healthimation business by Nemaura.” For context, Healthimation (view website here) is a healthcare animation company that has developed an interactive weight loss management program called “Why WAIT” based on the Joslin weight loss program of the same name. Below, FENIX provides insight into the potential Nemaura acquisition and thoughts on how Healthimation may act more to attract new patients than actually drive outcomes.

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.

Biocon Levels-up Insulin Strategy – Biocon CY Q2 ’20 Earnings Update

Biocon hosted its CY Q2 ’20 earnings call (FY Q1 ’21) and provided updates to the business including its biosimilar insulins portfolio (view press release). Of note, Biocon Biologics CEO Christiane Hamacher commented that the recent Voluntis “…digital therapeutic is not a nice to have, it’s a must-have.” Below, FENIX provides an updated perspective on the Biocon/Voluntis partnership, including thoughts on how the partnership may signal that Biocon could have altered its bs-insulin strategy.

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 Partners with Current Health for Remote Patient Monitoring; Nemaura to Integrate with Activity Trackers; Roche Q2 ’20 Earnings Update

Three diabetes-related news items have been observed: Dexcom has partnered with Current Health for remote patient monitoring, Nemaura announced it will integrate activity tracker data into its proBEAT app and Roche hosted its Q2 ’20 earnings call (press release; slides). 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.

New Non-Invasive CGM Player Emerges (Movano); Dexcom G6 Direct-to-Apple Watch Delayed?

Last week, Movano Inc. (view website), the developer of a novel non-invasive CGM, announced it exited “stealth mode” following the receipt of $10M in additional funding. Since its founding in 2018, the company has raised a total of $27M. Below, FENIX provides insight into the new Movano CGM in the context of other non-invasive CGM technology as well as thoughts on Dexcom’s apparent delayed launch of its direct-to-Apple Watch feature and Abbott’s potential to offer a similar feature for Libre 2.

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 Fate Therapeutics Updates to their CAR-T Programs in DLBCL and MM; Q1 2020 Call

On Monday, May 11, Fate Therapeutics held their Q1 2020 earnings call (press release), highlighting clinical and preclinical development updates to their pipeline, operational progress, and the recently established collaboration with Janssen for iPSC-derived CAR-NK and CAR-T assets. Below, FENIX provides thoughts on Fate’s cell therapy clinical strategy, particularly in the context of the current COVID-19 pandemic.

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.

Lexicon Reports Remaining Topline Ph3 Sota T2DM Results; Biocon Partners with Voluntis For Digital Insulin Solution

Two diabetes-related news items have been observed: Lexicon reported topline results from the four remaining sotagliflozin T2DM Ph3 trials and Biocon partnered with Voluntis to integrate Biocon bs-insulins with Voluntis’s Insulia automated dose calculator. Below, FENIX provides thoughts on the Lexicon Ph3 sota T2DM data in the context of the company’s decision not to move forward in T2DM without a strategic partner as well as potential insight into the Biocon/Voluntis partnership.

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.