Category Archives: Other

Provention Bio Completes Teplizumab BLA Submission

Provention Bio announced it completed the teplizumab rolling BLA submission for the prevention of T1DM in at-risk patients. Recall, in August 2020, FDA granted Breakthrough Therapy Designation for the teplizumab T1DM prevention indication. Below, FENIX provides thoughts on the potential Provention Bio missed filing deadline opportunity.

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 to use PRV for Sema Obesity; Ph1 Glucose-responsive Insulin Trial Initiated; Novo Q3 ’20 Earnings Update

Novo Nordisk hosted its Q3 ’20 earnings call (press release; slides) and provided updates across its pipeline and commercial activities, including the ongoing Rybelus launch, positive ziltivekimab Ph2b topline results, and Ph1 initiation for a novel glucose-responsive insulin. Additionally, Novo disclosed plans to use its PRV for the semaglutide 2.4mg obesity FDA submission. Below, FENIX provides highlights and thoughts from the call, including insight into a hidden importance of using the PRV for the sema 2.4mg obesity filing.

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 Medical Q2 ’20 Earnings Update; Cecelia Health Secures $13M in Series B Funding

Two diabetes-related news items have been observed: Nemaura Medical announced its Q2 ’20 earnings (press release) and Cecelia Health announced a Series B funding round of $13M. Below, FENIX provides highlights and insight 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.

Lilly, Novartis, Pfizer, and Merck Q3 ’20 Earnings Updates

Lilly, Novartis, Pfizer, and Merck each hosted their respective Q3 ’20 earnings calls and provided updates across a variety of topics. Importantly, it was disclosed that FDA has requested an advisory committee meeting to discuss Novartis’s Entresto PARAGON-HF submission. Below, FENIX provides highlights and insights from the respective earnings 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.

FIDELIO Demonstrates 18% RRR; DAPA-CKD and EMPEROR-Reduced Sub-Analyses

On the second day of Kidney Week 2020, three notable data sets were released: Bayer’s FIDELIO-DKD study demonstrated an 18% RRR in the primary composite endpoint (view press release; view NEJM publication); AstraZeneca presented a DAPA-CKD sub-analysis that demonstrated a reduction in the composite endpoint irrespective of the underlying CKD cause (view press release); BI/Lilly presented an EMPEROR-Reduced sub-analysis showing no difference in CV/renal outcomes regardless of baseline CKD (view press release). Below, FENIX provides highlights and implications of the data with a particular focus on FIDELIO.

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.

Abbott Q3 ’20 Earnings Update; Novo Licenses Antibody Engineering Tech From Chugai

Two diabetes-related news items have been observed: Abbott hosted its Q3 ’20 earnings call (press release) and Chugai licensed its antibody engineering technology to Novo Nordisk (press release). Below, FENIX provides highlights from the respective news items as well as insight into how Novo may leverage Chugai’s antibody technology.

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 AZD9977 + Dapa Ph2b Trial in HF+CKD (MIRACLE)

A CT.gov record has been observed for a new Ph2b trial evaluating AZD9977, a novel mineralocorticoid receptor modulator (MCR), as add-on to dapagliflozin in patients with HF and CKD. The trial initiation is in-line with AZ’s commentary from its Q2 ’20 earnings call (previous FENIX insight). Of note, John McMurray is the PI for the MIRACLE trial. McMurray previously served as the PI for DAPA-HF and a member of the executive committee for DAPA-CKD. Below, FENIX provides an overview of the MIRACLE trial as well as why AZ’s pursuit of accelerated approval for AZD9977 could make sense.

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.

Poxel Q3 ’20 Earnings; NASH Pipeline Updates

Poxel announced its Q3 ’20 earnings and provided an update on its pipeline advancements, but did not host an associated webcast. Interestingly, the Q3 earnings update comes just one month after the company hosted its H1 ’20 results webcast in September 2020. Below, FENIX provides key updates from the press release as well as insight on Poxel’s Imeglimin for T2DM and other NASH development programs.

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.

First Results for Bayer’s FIDELIO @ Kidney Week; ASN High-impact Trials Released

On Friday Oct 9, ASN posted more sessions for Virtual Kidney Week. Importantly, Bayer’s FIDELIO-DKD trial for finerenone will seemingly have first results presented during Kidney Week, rather than at Virtual AHA (previous FENIX insight). Below, FENIX provides a bit more detail and thought on a dynamic 3-4 weeks between Kidney Week and AHA.

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.

Livongo Partners with Fresenius for CKD; New CGM/AID Hospital Guidelines

Two diabetes-related news has been observed: Livongo and Fresenius Medical Care announced a partnership focusing on a digital solution for CKD and CGM and AID hospital consensus guidelines were published in JDST. Below, FENIX provides highlights and insights from 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.