Category Archives: Basal Insulin

Lilly Green Lights Two Next-Gen Incretin Ph3 Programs; Lilly 2023 Guidance Call

Lilly hosted its 2023 guidance call (slides; webcast) and provided key pipeline updates and an overview of potential upcoming milestones. Importantly, Lilly announced plans to advance its GGG tri-agonist (retatrutide) and oral GLP-1R NPA (orfoglipron) into Ph3 development. Additionally, Lilly disclosed that the final pivotal QW insulin trial (QWINT-1) will evaluate a fixed dose using the same Mounjaro/Trulicity auto-injector. Below, FENIX provides highlights and insights from the event including a readthrough to new obesity development entrants, specifically Pfizer and Amgen.

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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Biocon Completes Viatris Biosimilars Business Acquisition; Nemaura Launches Miboko Pilot Program in UK; BMS Terminates CV Partnership with uniQure

Three cardiometabolic-related news items have been observed: Biocon announced (view press release) the completed acquisition of Viatris’s biosimilar business (view press release); Nemaura announced the launch of its Miboko pilot program in the UK (view press release); and BMS reportedly terminated its research collaboration with uniQure (view article). Below, FENIX provides context and insight on the respective news items, including Nemaura’s challenged balance sheet.

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

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Medtronic CY Q3 ’22 Earnings Update; Novo Expands Manufacturing Facilities; FDA Approves Lilly’s Rezvoglar as an Interchangeable Biosimilar; Oramed Presents Additional Ph2 PRMD-0801 NASH Data

Four cardio-metabolic related news items have been observed: Medtronic hosted its CY Q3 ’22 earnings call (press release; slides); Novo announced plans to invest DKK 5.4B (~$750M USD) in the expansion of manufacturing facilities in Denmark (view press release); FDA approved Lilly’s Rezvoglar (bs-glargine) as an interchangeable to Sanofi’s Lantus (view label; view article); and Oramed hosted an event to discuss data from its Ph2 trial evaluating 8mg ORMD-0801 compared to placebo in 32 participants with T2DM and NASH (slides; webcast; press release). Below, FENIX provides context and insight on 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.

Lilly and Novo Leave Twitter Advertising; Insulet Issues O5 Medical Device Correction; Biocon, Movano, and Nemaura Q3 ’22 Earnings Updates

A series of cardiometabolic-related updates have been observed: Lilly (view article) and Novo (view article) have reportedly halted Twitter advertising; Insulet announced an Omnipod 5 voluntary medical device correction in the US; Biocon (press release), Movano (press release), and Nemaura (press release) hosted their respective Q3 ’22 earnings calls. Below, FENIX provides context and insight on 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.

Novo Q3 ’22 London Earnings

Key takeaways from Novo’s Q3 ’22 London 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.

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Purchase Blast$599.00

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

Tandem and Lannett Q3 ’22 Earnings Updates; Indigo Expands into US; OrsoBio Acquires T2DM and NASH Assets

A series of cardiometabolic-related news items have been observed: Tandem (press release) and Lannett (press release) hosted their CY Q3 ’22 earnings calls; Indigo Diabetes announced the creation of a US entity and appointment of Peter Devlin as President to support the development and commercialization of its continuous multi-metabolite (CMM) device; and Orso Bio acquired a T2DM asset from Shionogi (press release) and exclusive global rights for intellectual property from Yale University to develop mitochondrial protonophores (press release). Below, FENIX provides highlights and insights for the respective new 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.

Novo Nordisk Q3 ’22 Earnings Update; FY Guidance Raised

Novo Nordisk hosted its Q3 ’22 earnings call (press release; slides) and announced an increase to its 2022 financial guidance. During the call, management provided updates across its business, including the semaglutide global supply constraints as well as the high-dose oral sema and new QW oral sema development projects. Additionally, Novo disclosed it has terminated development of its oral PCSK9i and LA-GDF15 development programs. Of note, the Q&A portion of the call was terminated early due to technical difficulties. 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.

Pfizer, Esperion, and Intercept Q3 ’22 Earnings Updates; First Patient Dosed in Biomea’s Ph1/2 BMF-219 T2DM Trial

A series of cardiometabolic-related news items have been observed: Pfizer (press release; slides), Esperion (press release; slides), and Intercept (press release; slides) hosted their Q3 ’22 earnings call; and Biomea announced the first T2DM patient has been dosed in the Ph1/2 COVALENT-111 trial evaluating the company’s novel menin inhibitor, BMF-219. Below, FENIX provides highlights and insights for the respective new 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 Q3 ’22 Earnings Update

Lilly hosted its Q3 ’22 earnings call (press release; slides) and provided updates across its CVRM portfolio. Unsurprisingly, much of the call was focused on the Mounjaro US launch, manufacturing capacity considerations, and LCM initiatives. Other topics highlighted during the call included the ongoing QW insulin Ph3 program (QWINT), recent Tempo Smart Button US/EU regulatory approvals, and ANGPTL-3 siRNA advancement into Ph2. 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.

Vertex and Sanofi Q3 ’22 Earnings Updates; Sciwind Reports Positive Interim Results from Ph2b Ecnoglutide Obesity Trial

A series of cardiometabolic-related news items have been observed: Vertex (press release; slides) and Sanofi (press release; slides) hosted their respective Q3 ’22 earnings calls; and Sciwind announced positive results from an interim analysis of the ecnoglutide (XW003) Ph2b trial in obesity. 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.