Category Archives: Topics

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.

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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.

Dexcom Q3 ’22 Earnings Update; Kerendia Receives New Recommendations from ADA and KDIGO

A series of cardiometabolic-related news items have been observed: Dexcom hosted its Q3 ’22 earnings call (press release; slides); and Bayer announced that Kerendia (finerenone) received a favorable recommendation from both ADA and KDIGO for the treatment of CKD associated with T2DM. 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.

Teladoc, Alnylam, and Amarin Q3 ’22 Earnings Updates

A series of cardiometabolic-related news items have been observed: Teladoc (press release; slides), Alnylam (press release; slides), and Amarin (press release; slides) hosted their Q3 ’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.

Biocorp and Novo Sign New Connected Care Agreement; Daprodustat Adcom: 13-3 in Favor of Dapro in DD; 5-11 Against Dapro in NDD

Two cardiometabolic-related news items have been observed: Biocorp announced it signed a new agreement with Novo Nordisk reinforcing their partnership to develop the Mallya smart add-on device compatible with the Novo FlexTouch platform; and FDA hosted an adcom for GSK’s daprodustat where the panel voted 13-3 in favor of the dapro benefit/risk profile in the DD patient population and 5-11 against the benefit/risk profile in the NDD patient population. 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.

Novartis and Adocia Q3 ’22 Earnings Updates

Two cardiometabolic-related news items have been observed; Novartis (press release; slides) hosted its Q3 ’22 earnings call; and Adocia issued a press release for its Q3 ’22 earnings, though it did not host an associated webcast. Below, FENIX provides highlights and insights from 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.

Biocon Receives Second Bs-aspart CRL; EMA Approves Malaysian Facility

Biocon disclosed that the company received a second CRL from FDA regarding its bs-aspart BLA filed by Viatris  (view announcement). For context, Biocon received its first bs-aspart CRL from FDA in January 2022 (view Biocon announcement). In the same announcement, Biocon noted its integrated insulin manufacturing facility in Malaysia was approved by EMA following a July 2022 site inspection. Below FENIX provides brief thoughts on the new CRL and potential impact on the bs-aspart approval timeline.

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 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.

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 Launches 770G Personalized Insights Program; GSK Initiates Ph2b NASH Trial; J&J Q3 ’22 Earnings Update

Three cardiometabolic-related news items have been observed: Medtronic announced the launch of a new personalized program, called My Insights, which is designed to support patients using the MiniMed 770G AID system (view website); a new GSK-sponsored Ph2b trial (HORIZON) has been observed evaluating GSK4532990 (HSD17B13 silencer) in adults with NASH (view CT.gov record); and J&J hosted their Q3 ‘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.

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.

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.