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Novo Withdraws PIONEER START Trial; Onduo Partners with Sword Health; Nemaura and Movano Q2 ’22 Earnings Updates

A series of cardiometabolic updates have been observed: Novo’s PIONEER START trial (H2H oral sema vs. empa) has been withdrawn (CT.gov record); Onduo announced a partnership with Sword Health to integrate Sword Health’s musculoskeletal digital solution (press release); and Nemaura (press release) and Movano (press release; webcast) released their Q2 ’22 earnings. 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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Sean Saint Takes Over as Beta Bionics CEO

Beta Bionics announced it has appointed Sean Saint (view LinkedIn; pictured below) as the company’s new CEO and board member. Saint will be replacing Martha Goldberg Aronson (view LinkedIn) who will remain on the Beta Bionics Board of Directors after serving as the interim CEO since February 2022. Prior to Beta Bionics, Saint founded and led Companion Medical, which was acquired by Medtronic in August 2020 (previous FENIX insight). More recently, in April 2022, Saint co-founded a new diabetes insulin delivery company called Luna Diabetes in collaboration with other diabetes device veterans including Jon Brilliant (view LinkedIn), John Sjolund (view LinkedIn), and Jasper Benke (view LinkedIn; previous FENIX insight). Below, FENIX provides brief thoughts on Saint’s appointment as Beta Bionics’s new CEO and what it means for the company’s future as it prepares for the launch of its insulin-only iLet bionic pancreas (previous FENIX insight).

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.

DELIVER Filed in US? August 2022 CHMP Agenda

The CHMP agenda for this month’s meeting (August 16-19) has been released and includes several cardiometabolic-related agenda items. Of note, the August CHMP meeting only has written procedures, not oral explanations. Notably, AZ’s Forxiga (dapagliflozin) has been filed for an indication extension based on the DELIVER HFpEF trial results. Below, FENIX provides highlights from the August 2022 CHMP agenda.

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.

Abbott Expands CGM Manufacturing Capacity; Dario and Embecta Q2 ‘22 Earnings Updates

Three cardiometabolic-related news items have been observed: Abbott reportedly plans to invest $450M to expand CGM manufacturing (view article); and Dario (press release) and Embecta (press release; slides) hosted their respective Q2 ‘22 earnings calls. 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.

Xeris, Zealand, and MannKind Q2 ’22 Earnings Updates

Three cardiometabolic-related news items have been observed: Xeris Biopharma (press release), Zealand (press release; slides), and MannKind (press release; slides) hosted their Q2 ’22 earnings calls. 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.

FDA Detects Impurities in Samples of Merck’s Januvia; Senseonics and Ionis Q2 ’22 Earnings Updates

Three cardiometabolic-related news items have been observed: FDA’s website has been updated noting elevated levels of NTTP have been observed in samples of sitagliptin (view here); and Senseonics (press release) and Ionis (press release; slides) hosted their respective Q2 ’22 earnings calls. 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.

Gan & Lee GZR4 IND Granted FDA Clearance; Viatris Q2 ’22 Earnings Update

Two cardiometabolic-related news items have been observed: Gan and Lee announced FDA accepted its IND application for a novel QW ultra-long-acting insulin (GZR4); and Viatris hosted its Q2 ’22 earnings call (press release; slides). 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.

Novo Q2 ’22 London Earnings; Vertex and Amgen Q2 ’22 Earnings Updates

A series of cardiometabolic-related news items have been observed: Novo Nordisk hosted its post-Q2 ’22 earnings (see previous FENIX insight on Q2 ’22 Novo earnings from August 3); Vertex (press release; slides), and Amgen (press release; slides) hosted their Q2 ’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.

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, Provention Bio, Bayer, and Regeneron Q2 ‘22 Earnings Updates; Abbott Partners with WeightWatchers

A series of cardiometabolic-related news items have been observed: Insulet (press release), Provention Bio (press release), Bayer (press release; slides), and Regeneron (press release; slides) hosted their respective earnings calls; and Abbott announced a partnership with WeightWatchers for Libre CGM data integration. 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.

Mounjaro Off to an Impressive Start; Lilly Q2 ’22 Earnings Update

Lilly hosted its Q2 ’22 earnings call (press release; slides) and provided updates across its CVRM portfolio. During the call, Lilly discussed the impressive Mounjaro launch trajectory, disclosed plans to initiate an H2H tirzepatide vs. Wegovy obesity trial (SURPASS 5), and reviewed other CVRM pipeline assets. Below, FENIX provides highlights and insights from the call, including a Mounjaro time-aligned launch analysis with Ozempic, Trulicity, Rybelsus, and Wegovy.

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.