Category Archives: Topics

Oramed Oral Insulin End-of-Ph2 FDA Meeting Provides Ph3 Development Clarity

Oramed announced it had a positive end-of-Ph2 meeting with FDA for its oral insulin (ORMD-0801). Following the meeting, Oramed said it plans to initiate two concurrent Ph3 trials. The company did not provide an updated timeline for Ph3 trial initiation, but it previously indicated the trials would begin in Q3 ’20 (previous FENIX insight). Below, FENIX provides brief thoughts on the Oramed news, including readthrough to Biocon’s oral insulin tregopil.

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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Thoughts on Precision’s Allogeneic CAR-T Programs in NHL and MM; Q1 2020 Call

On Friday, May 15, Precision Biosciences held their Q1 2020 earnings call (press release/presentation), highlighting the current clinical progress for their three Ph1/2 allogeneic CAR-T candidates:

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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Novo’s First Ph3 Icodec Trial (ONWARDS 1) Posted on CT.gov

A new CT.gov record has been observed for Novo Nordisk’s first Ph3 trial evaluating its QW insulin icodec insulin-naïve T2DM patients (ONWARDS 1). Novo appears to be branding the Ph3 program as “ONWARDS” in an effort to pay homage to the continued development story of insulin. In case you missed it, Lilly recently initiated two Ph2 trials for its QW insulin (LY3209590) in both T1DM and T2DM (previous FENIX insight). Below, FENIX provides an overview of the ONWARDS 1 trial as well as brief thoughts on Novo potentially providing additional clarity during its upcoming Q2 ’20 earnings call on August 6, 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.

Bayer Reports Finerenone T2DM DKD Renal Outcomes Trial Topline Results (FIDELIO-DKD) ; EMPEROR-Reduced at ESC 2020

Bayer announced positive topline results from its Ph3 FIDELIO-DKD trial evaluating finerenone in T2DM with CKD. Finerenone demonstrated a delayed progression to the primary composite endpoint (onset of kidney failure, sustained decrease of eGFR ≥ 40% from baseline over at least 4 weeks, or renal death). The specific risk reduction was not disclosed. Below, FENIX provides thoughts on the FIDELIO-DKD results including a curious observation that the press release did not mention anything about safety in the trial.

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.

Tandem and Medtronic Enter Into “Non-exclusive Patent Cross-license Agreement”

Tandem and Medtronic announced they have entered into a “non-exclusive patent cross-license agreement” for existing and new products and services relating to each companies’ diabetes portfolio; however, there are certain undisclosed exclusions. According to the press release, no payments are being exchanged, and additional terms of the deal are not being disclosed. Below, FENIX provides thoughts on this curious agreement in the context of Tandem’s recent win with UnitedHealthcare (previous FENIX insight).

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

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First Libre 3 Clinical Study Initiated

A CT.gov record has been observed for what is believed to be the first Abbott Libre 3 clinical trial. Abbott publicly disclosed the existence of Libre 3 during its Q1 ’19 earnings call (previous FENIX insight). Recall, the Libre 2 CGM was recently approved in the US, but its use with integrated systems is limited due to Vitamin C interference (previous FENIX insight). There is no mention of Vitamin C in the Libre 3 CT.gov record. Below, FENIX provides an overview of the new Libre 3 study as well as potential insight into the timing of its initiation in the context of the Libre 2 US label restrictions.

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.

Tandem Partners with JDRF for Diabetes Device Education Campaign; Livongo’s myStrength App Available for Free to Priority Health Members

Two diabetes-related news items have been observed: Tandem announced it is partnering with JDRF for a national T1DM educational awareness campaign focusing on diabetes technology and Priority Health is providing Livongo’s myStrength mental health app for free to its members. Below, FENIX provides insights into the respective news items, notably the timing of the Tandem/JDRF collaboration given the recent favorable reimbursement decision by UnitedHealthcare (previous FENIX insight).

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 Files PMA for Non-invasive CGM; Medtronic launches Mio Advance Infusion Set

Two diabetes-related news items have been observed: Nemaura Medical announced it has filed a PMA with FDA for its sugarBEAT non-invasive CGM and Medtronic launched the Mio Advance infusion set in the US. In conjunction with the Nemaura filing announcement, the company also hosted a call with investors discussing the company’s commercial efforts (US and ex-US), partnership opportunities, and development of a new continuous temperature monitor. Below, FENIX provides highlights and insights relating to the sugarBEAT PMA submission as well as brief thoughts on the new Medtronic infusion set.

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 Lilly QW Insulin Ph2 Trials in T1DM and T2DM

Two new Ph2 trials have been observed on CT.gov evaluating Lilly’s QW basal insulin (LY3209590) in T1DM (view CT.gov record) and insulin-naïve T2DM patients (view CT.gov record). Below, FENIX provides trial details and thoughts on the new trials in the context of Novo Nordisk’s QW basal insulin (icodec), which recently had full Ph2 results presented at ADA 2020 (previous FENIX insight).

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.

Novartis Ph1b PORTIA Results Presented at Virtual AACR II

On Monday, June 23, Novartis presented (Ulrich Jaeger et al, June 2020) updated clinical data from the Kymriah + pembrolizumab (pembro, a PD-1 inhibitor) Ph1 PORTIA study in ≥3L R/R DLBCL. Below, FENIX provides thoughts on the significance of this data, and particularly how it compares to recent CAR-T + checkpoint inhibitor data from Gilead (Yescarta), BMS (Liso-cel), and Autolus (AUTO3).

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.