Category Archives: GLP-1RA

Amgen Post-AHA 2022 Pipeline Update; Senseonics, Bayer, and MannKind Q3 ’22 Earnings Updates

A series of cardiometabolic-related news items have been observed: Amgen hosted a post-AHA investor call and provided updates on its General Medicine Portfolio (view slides; view webcast); and Senseonics (press release), Bayer (press release; slides), and MannKind (press release; slides) hosted their Q3 ’22 earnings calls. 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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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

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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.

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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.

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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.

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Purchase Blast$599.00

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Abbott Q3 ’22 Earnings Update; EMA Expects Ozempic Supply Shortage Into 2023

Two cardiometabolic-related news items have been observed: Abbott hosted its Q3 ’22 earnings call (press release; view infographic) and provided updates on its Libre business; and EMA updated its shortages catalog to include Ozempic (view update here). Below, FENIX provides highlights and insights for the respective new items, including insight into how recent Ozempic publicity may be exacerbating the semaglutide shortage.

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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Insulet to Replace Omnipod DASH PDMs; Pfizer Initiates New Ph2 QD Oral GLP-1RA vs. Rybelsus Trial; Novartis to Lay Off 400 Employees in Dublin

Three cardiometabolic-related updates have been observed: In a recent 8-K filing, Insulet disclosed it will cost the company between $35M-45M to replace Personal Diabetes Managers (PDM) for all current Omnipod DASH users globally due to reported issues with the PDM battery (Form 8-K); a new Pfizer-sponsored Ph2 trial evaluating its oral GLP-1RA (PF-07081532) vs. Rybelsus has been observed (view CT.gov record); and, it has been reported that Novartis plans to lay off 400 of its 1,000+ staff stationed at the company’s Dublin campus by EOY 2024 (view article). Below, FENIX provides insight on 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

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Indigo Expands Multi-Metabolite Sensor Development; GlucoTrack to Develop CGM for T1DM; AZ Initiates New Dapa + Zibotentan Ph2 Trial; Sciwind Initiates Patient Dosing in Ph1 Oral GLP-1RA Trial; Ascensia Completes Initial European E3 CGM Launch; October CHMP Agenda

A series of cardiometabolic-related news items have been observed from Indigo, GlucoTrack, AstraZeneca, Sciwind, Ascensia, and EMA. 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.

Dexcom Expands ex-US G7 Launch; Novo to Initiate OASIS 4 Ph3 Oral Sema Obesity Trial; Lilly to Initiate two Lp(a) Ph2 Trials; Better Therapeutic Publishes BT-001 Pivotal Trial Results in Diabetes Care

Four cardiometabolic-related news items have been observed: Dexcom announced the launch of Dexcom G7 CGM in the UK, Ireland, Germany, Austria, and Hong Kong and hosted an associated pre-recorded streaming event (view here); a Novo-sponsored Ph3 study (OASIS 4) evaluating QD 25mg oral semaglutide in overweight and obese participants has been observed (view CT.gov record); Lilly initiated two Ph2 studies evaluating QD oral LY3453329 (KRAKEN; view CT.gov record) and injectable LY3819469 (view CT.gov record) in adults with elevated Lp(a); and Better Therapeutics announced the publication of 90-day results from its pivotal trial for BT-001, in Diabetes Care. 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

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Pfizer to Advance Oral GLP-1RA Development; Pfizer EASD 2022 Investor Call

Pfizer hosted an EASD 2022 investor event during which the company discussed data for its two oral GLP-1RAs (PF-07081532 and PF-06882961), which were presented at the conference (view slides). For context, PF-07081532 is differentiated from PF-06882961 (danuglipron) as PF-07081532 is a QD oral GLP-1RA compared to danuglipron which is a BID oral GLP-1RA. Below, FENIX provides highlights and insights from the call relating to key commentary from management.

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.