Category Archives: Other

Novo Nordisk Center for Genomic Mechanisms of Disease Launched; Lifescan and Welldoc Partnership; Xeris Approved to Acquire StrongBridge Pharma; Oramed Reaches 50% Enrollment in NASH

A series of cardiometabolic-related news items have been observed: the Novo Nordisk Foundation and the Broad Institute of MIT and Harvard announced the launch of the Novo Nordisk Foundation Center for Genomic Mechanisms of Disease; Lifescan and Welldoc announced a partnership to integrate Welldoc’s chronic condition platform into the OneTouch Solutions portal; Xeris announced it received stockholder approval for the previously announced proposed acquisition of Strongbridge Biopharma; and Oramed announced it has reached over 50% enrollment in the Ph2 trial evaluating its oral insulin (ORMD-0801) in T2DM patients with NASH. 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.

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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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Purchase Blast$599.00

You can read the article’s full content online after purchase.

Another Inclisiran CVOT (VICTORION-2P); Not Even in Primary Prevention

A CT.gov record has been observed for another Ph3 inclisiran CVOT, called VICTORION-2 PREVENT (aka VICTORION-2P), in 15,000 adults 40 years of age and older with established ASCVD (view CT.gov record). Notably, the VICTORION-2P trial is evaluating inclisiran in secondary prevention, which is similar to ORION-4 (ongoing with primary completion in 2026; view CT.gov record). Below, FENIX provides additional trial details as well as thoughts on the trial design in comparison to ORION-4.

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.

Jardiance Receives Breakthrough Therapy Designation for HFpEF; Metacrine Ph2a NASH Trial Completes Enrollment; Dario Signs Northeast Regional Employer

A series of cardiometabolic-related news items have been observed: BI/Lilly announced FDA granted Breakthrough Therapy Designation (BTD) to Jardiance for the treatment of HFpEF; Metacrine announced the Ph2a trial evaluating MET642 in 180 patients with NASH has completed enrollment; and Dario Health announced it was selected as the digital health provider for a Northeast regional employer. 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.

Agentix Signs WW Licensing Agreement for T2DM, NAFLD, and Obesity Asset

Agentix announced it has entered into a WW exclusive license and technology transfer agreement with the National Health Research Institutes (NHRI) of Taiwan ROC. According to the press release, Agentix will license several NHRI patents and patent applications to develop, manufacture, and commercialize DBPR211 for the treatment of human disease. For context, DBPR211 is a peripherally restricted cannabinoid receptor 1 antagonist that has completed preliminary pre-clinical and in vivo testing requirements. Agentix intends to begin Ph1 trials by September 2022. Below, FENIX provides context and insights for the announcement.

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.

Dario Selected as Digital Behavioral Health Partner for PeopleOne Health

Dario Health announced it was selected as the digital behavioral health provider for PeopleOne Health, a regional primary care provider. According to the press release, Dario’s digital behavioral health solution will be available to PeopleOne patients beginning in September 2021. Below, FENIX provides thoughts on the announcement in the context of other recent contracts announced by Dario.

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.

Finerenone Likely to Remain an Add-on to SGLT2i; FIGARO-DKD and FIDELITY Results @ ESC 2021

Findings from the Ph3 FIGARO-DKD study were presented at ESC 2021 during a Hot Line Session and simultaneously published in the NEJM. Results demonstrated a 13% RRR in the primary composite endpoint (CV death, non-fatal MI, non-fatal stroke, or hHF). Furthermore, the FIDELITY meta-analysis from FIGARO-DKD and FIDELIO-DKD was also presented. Below, FENIX provides highlights, insights, and implications, including thoughts on if/how Bayer’s interest in Lexicon’s sotagliflozin may be evolving.

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’s IL-6 Ph3 CVOT Posted to CT.gov; Additional Diamyd T1DM Vaccine Analyses

Two cardiometabolic news items have been observed: Novo Nordisk has initiated the Ph3 ziltivekimab CVOT (ZEUS) in 6,200 adults with established ASCVD, CKD, and systemic inflammation; and Diamyd announced the results from two new analyses on the meta-analysis dataset from the four previous trials evaluating the efficacy and safety of the Diamyd vaccine in T1DM. 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.

Lexicon and Amarin Present Data at ESC 2021

Two cardiometabolic-related news items have been observed: Lexicon announced the presentation of additional analyses from the SOLOIST and SCORED Ph3 trials at the ESC 2021 Digital Experience; and Amarin announced the on-demand, Late Breaking Science Presentation at ESC 2021 of data from the prior MI subgroup analysis of its Vascepa/Vazkepa (icosapent ethyl) Ph3 REDUCE-IT study. Of note, the full ESC 2021 conference takes place August 27-30. 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.