Tag Archives: Medtronic

Medtronic CY Q3 ’23 (FY Q2 ’24) Earnings; Lilly to Build Production Plant in Germany; Lilly Initiates Ph1 T2DM Study; Carmot Files for IPO

Four cardiometabolic-related news items have been observed: Medtronic hosted its CY Q3 ’23 (FY Q2 ’24) earnings call (press release; slides); Lilly announced plans to build a $2.5B production plant in western Germany to support diabetes/obesity supply (view press release); Lilly initiated a Ph1 study evaluating an unknown compound (LY3938577) vs. insulin degludec (view CT.gov record); and Carmot Therapeutics has filed for an IPO (view SEC filing). Below, FENIX provides highlights and insights for the respective 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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ITCA 650 Negative Adcom Vote; Medtronic Receives CE Mark for Simplera; 89bio’s Pegozafermin in NASH Receives Breakthrough Therapy Designation; Dexcom Canada Partners with RxFood for Diabetes Management; Novo Nordisk Foundation to Establish New Cell Therapy Facility

A series of cardiometabolic-related news items have been observed from FDA, Medtronic, 89bio, Dexcom, and Novo. 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.

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Purchase Blast$599.00

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Medtronic CY Q2 ’23 (FY Q1 ’24) Earnings; Lilly Initiates Retatrutide Test Device Study

Two cardiometabolic-related news items have been observed: Medtronic hosted its CY Q2 ’23 (FY Q1 ’24) earnings call (press release; slides); and Lilly initiated a Ph1 relative bioavailability study comparing SC retatrutide (LY3437943) administered by a test device vs. a reference device in healthy participants (view CT.gov record). 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.

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Purchase Blast$599.00

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

Medtronic Admits It Can’t Achieve iCGM Designation?; 2023 ADA Investor Event

Medtronic hosted its ADA 2023 investor event (view slides) and provided updates to the company’s diabetes business. Of note, commentary from Medtronic senior management indicates the Simplera CGM will not achieve an iCGM designation. Additionally, it should be noted that Medtronic’s CEO, Geoff Martha, participated in the ADA investor event, which hasn’t been the case in recent memory. Below, FENIX provides an overview of the Medtronic 2023 ADA investor event, including thoughts on Medtronic’s continued inability to achieve iCGM designation.

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.

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.

Medtronic CY Q1 ‘23 (FY Q4 ‘23) earnings update

Medtronic hosted its CY Q1 ‘23 (FY Q4 ‘23) earnings call (press release; slides) and provided brief updates to its diabetes business. Importantly, Medtronic disclosed plans to acquire EOFlow Co. Ltd. for its patch pump technology (view press release). Additionally, Medtronic will be hosting an investor event at ADA 2023 where it will provide more details on its diabetes portfolio and pipeline. Below, FENIX provides highlights and insights from the earnings call, including thoughts on how the EOFlow acquisition fits into Medtronic’s strategy to turn around its struggling diabetes business.

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Medtronic Resolves FDA Warning Letter; HSR Waiting Period for Sanofi’s Provention Bio Acquisition Expires; Roche Q1 ’23 Earnings

Three cardiometabolic-related news items have been observed: Medtronic announced FDA lifted the warning letter issued at its diabetes headquarters in Northridge, CA, in December 2021 (view press release); Sanofi announced the waiting period under the Hart-Scott-Rodino Act of 1976 (HSR Act) for its proposed acquisition of Provention Bio has expired (view press release); and Roche hosted its Q1 ‘23 earnings call (press release; slides). 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.

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Purchase Blast$599.00

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Lilly to Divest Baqsimi to Amphastar; Medtronic 780G+GS4 FDA Approval; April CHMP Agenda

Three cardiometabolic-related news items have been observed: Lilly announced it entered into a definitive agreement with Amphastar Pharmaceuticals to divest Baqsimi worldwide rights (view press release); Medtronic’s MiniMed 780G system with the Guardian Sensor 4 (GS4) has received FDA approval (view press release); and the CHMP agenda (view here) for this month’s meeting (April 24-26) has been released. Below, FENIX provides highlights and insights into the respective news items including insight into Lilly’s potential strategy behind the Baqsimi move.

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.

Dexcom’s Project Liberty Motives Are Confusing

At ATTD 2023, Dexcom hosted a symposium where it highlighted “Project Liberty,” a follow-on R&D initiative stemming from Dexcom’s 2018 acquisition of TypeZero. Dexcom said Project Liberty is intended to move AID algorithms beyond T1DM and into a broader subset of patients with diabetes, including T2DM. However, it is not readily apparent as to Project Liberty’s business case. Below, FENIX provides thoughts and hypotheses as to what Dexcom’s strategic rationale could be regarding Project Liberty.

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.

Medtronic and Esperion CY Q4 ’22 Earnings Updates; Akebia Receives Another FDA Response for Vadadustat; Wegovy and Vadadustat CHMP Opinions; February CHMP Agenda

A series of diabetes-related news items have been observed: Medtronic (press release; slides) and Esperion (press release; slides) hosted their respective CY Q4 ’22 earnings calls; Akebia received another FDA response regarding the vadadustat CRL appeal (press release); and the February CHMP Agenda was posted, including vadadustat and Wegovy (potential) opinions. Below, FENIX provides highlights and insights from the respective news items, including thoughts on Medtronic’s Simplera CGM approval timing.

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.