Category Archives: Topics

AZ Buys Oral GLP-1RA; Q3 ’23 Earnings Update

AstraZeneca hosted its Q3 ’23 earnings call (press release; slides) and provided updates to its CVRM business, including insight on its newly acquired oral GLP-1RA. Just prior to the earnings release, AZ announced it entered into an exclusive licensing agreement for ECC5004, a QD oral GLP-1RA, from Eccogene (view press release). Below, FENIX provides highlights and insights from the call, including thoughts on AZ’s decision to acquire the new oral GLP-1RA.

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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OrsoBio Secures $60M in Series A Funding with Lilly as a New Investor; Diamyd Collaborates with DiaUnion for Ph2 T1DM Trial Recruitment; Esperion, Altimmune, MannKind, and Viatris Q3 ’23 Earnings

A series of cardiometabolic-related news items have been observed from OrsoBio, Diamyd, Esperion, Altimmune, MannKind, and Viatris. Below, FENIX provides highlights and insights into 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.

Tirzepatide Obesity Indication Approved as “Zepbound” 

Lilly announced that FDA approved tirzepatide as “Zepbound” for adults with obesity or overweight that also have weight-related comorbidities such as hypertension, dyslipidemia, T2DM, OSA, or CVD (view label). Of note, FDA also made an announcement regarding the approval (view here). Tirzepatide remains under review in the EU, UK, China, and other markets. Lilly stated Zepbound is anticipated to be launched in the US by EOY 2023 in six doses (2.5mg, 5mg, 7.5mg, 10mg, 12.5mg, and 15mg). In the press release, Lilly specifically disclosed the Zepbound WAC price of $1,059.87, which Lilly noted is 20% less expensive than Wegovy. FENIX will conduct a full label analysis of Zepbound in the coming days.

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 Empa + BI 690517 Ph2 CKD Data; Madrigal and Vertex Q3 ‘23 Earnings; MannKind Completes INHALE-3 Enrollment; November CHMP Agenda

A series of cardiometabolic-related news items have been observed from Boehringer Ingelheim, Madrigal, Vertex, MannKind, and EMA. Below, FENIX provides highlights and insights into 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 London Q3 ’23 Earnings; Terns Doses First Patient in Ph1 Obesity Trial; Ionis, Regeneron, and Dario Q3 ’23 Earnings

A series of cardiometabolic-related news items have been observed from Novo Nordisk, Terns, Ionis, Regeneron, and Dario. Below, FENIX provides highlights and insights into 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.

Insulet Q3 ’23 Earnings Update

Insulet hosted its Q3 ’23 earnings call (press release; slides) and provided updates to its business, including the ongoing O5 launch and development programs, Omnipod GO commercial pilot, the EOFlow lawsuit, and more. 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.

Lilly Q3 ’23 Earnings Update

Lilly hosted its Q3 ’23 earnings call (press release; slides) and provided updates across its CVRM portfolio. Management noted the 2024 guidance call will be held in January which is new as the company traditionally hosted these calls in December of the preceding year. 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.

SELECT Receives Priority Review; High-dose Oral Sema Delayed; Novo Q3 ’23 Earnings

Novo Nordisk hosted its Q3 ’23 earnings call (press release; slides) and provided updates across its CVRM portfolio. Novo provided important new disclosures including SELECT’s priority review, a high-dose oral sema regulatory filing delay, and a new subcutaneous amycretin asset in Ph1 development. Below, FENIX provides highlights and insights from the call, including thoughts on why SC amycretin makes sense from a strategic standpoint.

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.

Sibionics Receives GS1 CGM CE Mark; Silence Therapeutics Announces Positive Ph1 Lp(a) Results; Lilly Initiates Another Oral GLP-1RA Ph3 Trial; Tandem and Amarin Q3 ‘23 Earnings; Lexicon Expands Inpefa Access; Dario Launches BGM Compatible With iPhone 15; Abbott, Insulet, and BI/Lilly Announce National Diabetes Awareness Month Initiatives

A series of cardiometabolic-related news items have been observed from Sibionics, Silence Therapeutics, Lilly, Tandem, Amarin, Lexicon, Dario, Abbott, Insulet, and BI/Lilly. Below, FENIX provides highlights and insights into 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 Acquires Rights to Gene Editing Programs for CVD; Know Labs to Present at Bernstein CGM Disruptors Conference; Pharmacies Struggle to Afford GLP-1RAs; Sigrid Secures Funding for Diabetes/Obesity; Porosome Announces New T1DM/T2DM Treatment Approach; Pfizer and Amgen Q3 ’23 Earnings

A series of cardiometabolic-related news items have been observed from Lilly/Verve, Know Labs, Endpoints News, Sigrid Therapeutics, Porosome Therapeutics, Pfizer, and Amgen. Below, FENIX provides highlights and insights into 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.