Category Archives: GLP-1RA

September 13-16 CHMP Agenda; Dexcom Exec Joins iRhythm as CEO; Provention Teplizumab Update

A series of cardiometabolic-related news items have been observed: the CHMP agenda for this month (September 13-16) has been released; iRhythm announced Quentin Blackford, outgoing Dexcom COO, will join the company as President and CEO, effective October 4, 2021; and Provention Bio issued an update on the BLA resubmission of teplizumab to delay the onset of T1DM in at-risk individuals (press release). 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.

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Oral Sema Ph3 Obesity Program Initiated; GlucoModicum Appoints Former Dexcom Exec; Lilly Contributes to T1DM Camp Initiative

A series of cardiometabolic-related news items have recently been observed: a Novo Nordisk trial evaluating oral semaglutide in adults with obesity, called OASIS 1, has been observed on CT.gov; GlucoModicum announced the appointment of Peter Gerhardsson to Senior Advisor; and Lilly announced a commitment of nearly $1M donation over the next three years, in conjunction with the Helmsley Charitable Trust, to support a T1DM Camp Initiative. 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.

Ph3 Icosema Trial Observed; Novel T1DM Treatment Development; DIAGNODE-3 Trial Observed

Three cardiometabolic-related news items have recently been observed: Novo Nordisk initiated the first Ph3 icosema trial (COMBINE 3) evaluating icosema (QW insulin icodec + semaglutide) vs. basal-bolus in T2DM patients; Adhera Therapeutics announced an agreement with Melior Pharma for Adhera to license MLR-1023 (tolimidone) for the development of a novel T1DM therapeutic option; and Diamyd initiated a Ph3 trial (DIAGNODE-3) evaluating the Diamyd diabetes vaccine in recently diagnosed T1DM patients carrying the HLA DR3-DQ2 haplotype. 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.

Novo Q2 ’21 Post-earnings Event

Novo Nordisk hosted its post-Q2 ’21 earnings event and provided further details on the obesity market and Wegovy launch. Below, FENIX provides an overview of the commentary from senior management beyond what was discussed during the Q2 ’21 earnings call as well as 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.

Wegovy Launch Impresses; Guidance Raised; Novo Q2 ’21 Earnings Update

Novo Nordisk hosted its Q2 ’21 earnings call and provided updates across its commercial and pipeline activities, including the ongoing Wegovy and Rybelsus launches and Novo’s intentions to develop and launch an ASCVD or HF product between 2024 and 2028. Of note, the earnings call was previously scheduled for tomorrow (August 5, 2021), but the company curiously moved it up by a day. 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.

Bydureon BCise US Pediatric Approval; Biocon FY Q1 ’22 (CY Q2 ’21) Earnings Update; Afrezza Pediatric Ph3 Trial Observed

A series of diabetes-related news items have recently been observed: AZ announced FDA approval of Bydureon BCise for patients 10-17 years of age with T2DM; Biocon hosted its FY Q1 ’22 (CY Q2 ’21) earnings call; and a CT.gov record has been observed for MannKind’s first Afrezza Ph3 pediatric study, called INHALE-1. 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.

Why Lilly Will Terminate GGG; Lilly ADA 2021 Investor Update

Lilly hosted an ADA investor event in which the company covered tirzepatide, tri-agonist GGG, QW basal insulin, oral incretins, and a summary slide of Lilly’s CVRM R&D portfolio. Below, FENIX provides highlights and insights from the event, including why GGG won’t progress beyond Ph2.

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.

ADA 2021 Key Press Releases (June 29)

On the final day of ADA 2021, six cardiometabolic-related press releases were observed from Novo/Walmart, Lilly, Lexicon, Hanmi, Dario, and Adocia. Below, FENIX provides context and analysis for the announcements, including an RAI price-ranking following the Novo/Walmart partnership for ReliOn NovoLog.

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.

ADA 2021 Key Press Releases (June 28)

On day four of ADA 2021, eight cardiometabolic-related news items were observed from Bigfoot, AZ, Mannkind, Medtronic, Senseonics, BI/Lilly, Sanofi, and REMD Biotherapeutics. Below, FENIX provides context and analysis for the announcements, including thoughts on how the ALT increases observed in REMD’s Ph2 volagidemab trial could spell disaster in Ph3.

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 Dual Agonist T2DM Intentions Disclosed at ADA Investor Event; Lilly Could Pursue Hypo Claim vs. Degludec in QW Basal Ph3

Two cardiometabolic presentations from Novo Nordisk and Lilly have recently been observed: Novo hosted an ADA investor event and Lilly presented CGM data from the Ph2 QW insulin trial at ADA 2021. Below, FENIX provides insight on what Novo really hopes to accomplish vs. tirzepatide, and how Lilly may pursue a hypo reduction claim vs. degludec for its QW basal insulin.

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.