Category Archives: Other

STEP HFpEF Topline Results; Novo ADA 2023 Investor Event

Novo Nordisk hosted an investor event during ADA 2023 (view slides) and also raised its FY 2023 financial guidance to 24-30%. During the call, Novo provided an overview of the QW insulin icodec Ph3 program and value proposition, insight into the Ph3 cagrisema T2DM program, high-dose oral semaglutide in T2DM and obesity, and topline STEP-HFpEF results. Of note, management briefly mentioned that SELECT CVOT data will be presented in the near future. Below, FENIX provides highlights and insights from the Novo ADA 2023 investor event.

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 2023 Key Press Releases (June 25)

On the third day of ADA 2023, two cardiometabolic-related news items were observed. 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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Purchase Blast$599.00

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

ADA 2023 Key Press Releases (June 24)

On the second day of ADA 2023, ten cardiometabolic-related news items were observed from Lilly, Zealand, BI, Novo Nordisk, Biomea Fusion, Sciwind Biosciences, Medtronic, Vertex, and Esperion. 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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Purchase Blast$599.00

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

ADA 2023 Key Press Releases (June 23)

On the first day of ADA 2023, two cardiometabolic-related news items were observed from BI/Lilly and Intercept. 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.

Intercept to Discontinue OCA NASH Development Following Second CRL

Intercept Pharmaceuticals announced it received a CRL from FDA regarding the obeticholic acid (OCA) NDA for the treatment of pre-cirrhotic liver fibrosis due to NASH. According to the press release, FDA indicated in the CRL that any resubmission of an NDA for OCA in NASH would require, at minimum, successful completion of the long-term outcomes phase of the REGENERATE study (view CT.gov record). As a result of the CRL, Intercept has decided to discontinue all NASH-related investment and restructure the company’s operations to strengthen its focus on rare and serious liver diseases. Below, FENIX provides brief thoughts on the CRL and Intercept’s decision.

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 Partners with Verve Therapeutics for Lp(a) Gene Editing Program; Zucara Receives Funding from JDRF

Two cardiometabolic-related news items have been observed: Verve Therapeutics announced a partnership with Lilly to advance Verve’s gene editing program targeting Lp(a) for the treatment of ASCVD, ischemic stroke, thrombosis, and aortic stenosis (view press release); and Zucara Therapeutics announced it received $2M in funding from JDRF for its ZONE study, a Ph2 trial evaluating ZT-01 to reduce nocturnal hypoglycemia events in T1DM patients (view press release). Below, FENIX provides context and insight on the respective news items, including brief thoughts on the Verve partnership.

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 Advertising Paused Due to High Demand; Inventiva Ph2 Lanifibranor T2DM and NAFLD Results; FDA Accepts Gan & Lee’s Bs-Aspart BLA

Three cardiometabolic-related news items have been observed: Ro has reportedly paused its Wegovy advertising due to the ongoing supply shortage (view article); Inventiva announced positive topline results from its Ph2 trial evaluating lanifibranor in patients with T2DM and NAFLD (view press release); and Gan & Lee announced FDA accepted the BLA for its biosimilar insulin aspart (view press release). Below, FENIX provides highlights and insights into the respective news items, including thoughts on the ongoing Wegovy supply issues.

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 to Acquire Chinook; Novo Nordisk Expands Danish Facility

Two cardiometabolic-related news items have been observed: Novartis and Chinook Therapeutics announced they have entered into an agreement where Novartis will acquire Chinook for $3.2B; and Novo Nordisk announced plans to invest ~$2.3B (15.9B DKK) in expanding the company’s existing API production facility in Denmark (view press release). Below, FENIX provides highlights and insights into the respective news items, including brief thoughts on the Chinook acquisition.

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.

AstraZeneca Partners for T1DM Cell Therapy; New Lilly Care Trial

Two cardiometabolic-related news items have been observed: AstraZeneca and Quell Therapeutics announced a collaboration to develop, manufacture, and commercialize autologous, engineered Treg cell therapies for T1DM and IBD; and Lilly initiated a trial evaluating adherence and glucose control of its connected Tempo pen system in conjunction with Dexcom and Glooko (view CT.gov record). Below, FENIX provides highlights and insights for the respective news items, including thoughts on how AZ’s collaboration fits with another one of its recent partnerships.

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 to Acquire Biocorp; Akero Announces Ph2b SYMMETRY Results; Enterin Initiates Ph1a ENT-03 Study

Novo to Acquire Biocorp; Akero Announces Ph2b SYMMETRY Results; Enterin Initiates Ph1a ENT-03 Study

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.