Category Archives: Topics

ADA 2019 Key Press Releases (June 9 and 10)

14 major news items were observed over the past 2 days including Provention Bio’s teplizumab, dasiglucagon pivotal data, DECLARE and EMPA-REG subanalyses, Afrezza pediatric and fixed titration data, Tandem and Insulet hybrid-closed loop data, and more. 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.

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Lilly REWIND and Tirzepatide Comments From ADA 2019 Investor Call

Lilly hosted its annual ADA 2019 investors call where senior management primarily discussed the REWIND CVOT readout and tirzepatide T2DM Ph2 results. Additionally, Lilly provided an overview and timeline for its Ph3 tirzepatide obesity program (SURMOUNT) and Ph2 tirzepatide NASH program (SYNERGY-NASH). Below, FENIX provides key commentary 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.

Novo ADA 2019 Investor Event Highlights

Novo Nordisk hosted its ADA 2019 investor event immediately following the data readout from Lilly’s REWIND CVOT. Unsurprisingly, Novo compared REWIND to LEADER and SUSTAIN 6. Of note, Novo disclosed plans to initiate its high-dose semaglutide study, SUSTAIN FORTE, in Q2 ‘19. Other topics covered during the call include semaglutide LCM, commentary on Lilly’s tirzepatide, connected pen data, QW basal insulin (LAI287), and more. Below, FENIX provides insights and 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.

Thoughts on REWIND; GLP-1RA Dynamics to Remain the Same

Results from REWIND, which have been 7 months in the making, were presented at the ADA 2019 conference and simultaneously published in The Lancet. In somewhat of a disappointing fashion, REWIND data demonstrated a 12% RRR in 3P-MACE (p=0.026) with nonstatistically significant benefit in both the primary (HR=0.87) and secondary prevention (HR=0.87) cohorts. However, as predicted by the FENIX team (but not Matt), the REWIND results were more in-line with Novo’s LEADER than SUSTAIN 6. Below, FENIX provides thoughts on the REWIND results as well as a favors/disfavors analysis.

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.

Medtronic Calls Out Tandem and Dexcom; Medtronic ADA 2019 Investor Event

Medtronic hosted its annual ADA investor event and provided updates to its diabetes business including a pipeline roadmap over the next 24 months (download slides here). The event appeared to have many of the same themes from the 2018 event with a large focus on competing externally (previous FENIX insight). However, this is believed to be the first time that Medtronic has specifically called out pump and CGM competitors (Tandem and Dexcom), and for the first time, Medtronic management was wearing prototype Synergy CGMs at the event. 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.

URLi ISRs Could Sting LLY; Ph3 Results Mixed

Lilly presented results from its two ultra-rapid-acting lispro (URLi) pivotal trials, PRONTO-T1D and PRONTO-T2D. Below, FENIX provides an overview of the data as well as thoughts on the imbalance in injection site reactions (ISRs) with URLi and the potential market implications.

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 Oral Sema Data, Tirzepatide Ph2 Analyses, New Medtronic Pivotal Studies; ADA 2019 Key Press Releases (June 8)

Today, nine major news items were observed including Novo’s PIONEER 2 (vs. Jardiance) and PIONEER 4 (vs. Victoza) data readouts, new Medtronic closed-loop, and CGM pivotal trials, and more. 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.

Tidepool Partners with Medtronic and Dexcom; ADA 2019 Key Press Releases (June 7)

Today, four major new items were observed including two new Tidepool partnerships with Medtronic and Dexcom as well as updated Companion Medical InPen features and Monarch Medical’s IOB algorithm 510(k) approval. Of note, the Medtronic/Tidepool partnership is believed to be the first external partnership as part of Medtronic’s notoriously closed diabetes device ecosystem. 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.

New Sanofi CEO; Xeris delayed: SENS approval, InPen-Dexcom; Zeal-BB; vTv; Adocia

Today, seven major new items were observed across Sanofi, Dexcom/Companion Medical, Xeris, Senseonics, Zealand/Beta Bionics, vTv, and Adocia. 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.

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ADA ’19 Key Data and Partnership Press Releases (June 5)

Ahead of the ADA 2019 conference start, a series of diabetes-device related press releases have been observed including Companion Medical, Glooko, DreaMed, Roche, CeQur, and Virta Health. 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.