Category Archives: SGLT2i

SELECT up for CHMP Opinion?; January CHMP Agenda; Akero Initiates Ph3 EFX MASH Trial

Two cardiometabolic-related news items have been observed: the CHMP agenda (view here) for this month’s meeting (January 22-25) has been released and includes Novo’s SELECT; and Akero initiated the second Ph3 study evaluating EFX in participants with non-cirrhotic MASH and F2 or F3 fibrosis (SYNCHRONY Histology; view CT.gov record). 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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Novo Resumes Shipments of Wegovy doses in US; Amgen to Acquire Cytokinetics?; Dexcom G7 Integrated with t:slim X2 OUS; Novo Initiates Additional Ph3 Ziltivekimab Trial in HF; BI Expands Greece Manufacturing Facility

A series of cardiometabolic-related news items have been observed from Novo, Amgen, Dexcom, and Boehringer Ingelheim. 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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JPM 2024 Day 4: MDGL, LXRX, MNKD, AKBA, and XERS; Novartis No Longer Pursuing Cytokinetics Acquisition

On the fourth and last day of JPM 2024, FENIX has provided coverage of presentations by other CVRM companies, including Madrigal, Lexicon, MannKind, and Akebia. Xeris also presented at JPM 2024 but had no meaningful discussion relating to its CVRM portfolio. Separately, one CVRM-related news item has been observed: Novartis has reportedly decided to no longer pursue a Cytokinetics acquisition (view article).

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.

JPM 2024 Day 2: ABT, PODD, NVO, LLY, AZN, BAY, BMF, TDOC; Embecta Files 510(k) for T2DM Patch Pump; Omada Partners with Amazon for Cardiometabolic Programs

On the second day of JPM 2024, FENIX has provided coverage of presentations by major CVRM companies, including Abbott, Insulet, Novo Nordisk, Lilly, AZ, Bayer, Biomea, and Teladoc. GSK and Sanofi also presented at JPM 2024 but had no meaningful discussion relating to their respective CVRM portfolios. Separately, two CVRM-related news items have been observed: Embecta announced it submitted a 510(k) filing to FDA for its open-loop patch pump for T2DM (view press release); and Omada Health announced a partnership with Amazon’s Health Condition Programs for its cardiometabolic programs (view press release).

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.

JPM 2024 Day 1: DXCM, MDT, AMGN, AKERO, ARWR, CYTO, NVS, VRTX, ALN, REGN; Tandem X2 Control-IQ Integrated with Libre 2 Plus; Supersapiens Launches Diabetes Platform; Novo Ph3 Icosema Results

On the first day of JPM 2023, FENIX has provided coverage of presentations by major CVRM companies, including Dexcom, Medtronic, Amgen, Akero, Arrowhead, Cytokinetics, Novartis, Vertex, Alnylam, and Regeneron. Pfizer and Merck also presented at JPM 2024 but had no meaningful discussion relating to their respective CVRM portfolios. Additionally, three separate CVRM-related news items have been observed: Tandem and Abbott announced the Tandem X2 Control-IQ AID system now integrates with Abbott’s Libre 2 Plus CGM (view press release); Novo announced topline results from the COMBINE 3 study evaluating icosema vs. basal-bolus treatment in T2DM (view press release); and Supersapiens announced the launch of its Supersapiens Diabetes platform (view post).

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 Initiates Orforglipron vs. Farxiga Ph3 Trial; Fractyl Selects its Rejuva GLP-1 Gene Therapy; Tiziana Files Patent for Foralumab + GLP-1RA; Merck GLP-1RAs Commentary; Rivus Completes HFpEF Ph2a Enrollment

A series of cardiometabolic-related news items have been observed from Lilly, Fractyl Health, Tiziana, Merck, and Rivus. 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.

Alnylam 2023 Pipeline Updates; Pfizer Full-Year 2024 Guidance Call; Zepbound Available Through Ro Body Program; Novo Challenges IRA’s Constitutional Legitimacy; Tandem Source Full Launch in US

A series of cardiometabolic-related news items have been observed from Alnylam, Roche, Ro, Novo Nordisk, and Tandem. 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.

SURMOUNT-4 Results Published in JAMA; December CHMP Agenda; Fractyl Health Presents GLP-1RA PGTx Findings at WCIRDC 2023

Three cardiometabolic-related news items have been observed: Lilly announced detailed results from SURMOUNT-4 have been published in JAMA (view press release; view publication); the CHMP agenda (view here) for this month’s meeting (December 11-14) has been released; and Fractyl Health presented findings from its Rejuva GLP-1RA-based gene therapy candidate (GLP-1RA PGTx) vs. semaglutide at WCIRDC 2023 in Los Angeles, CA on December 7-9, 2023 (view press release). 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.

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 Terminates EOFlow Acquistion; t:slim X2 Now Available with Dexcom G7 Integration; Indoco Receives Tentative Approval for Generic Invokana

Three cardiometabolic-related news items have been observed: Medtronic announced it has terminated the EOFlow acquisition (view SEC filing); Dexcom (view press release) and Tandem (view press release) announced the launch of updated t:slim X2 insulin pump software with Dexcom G7 CGM integration in the US; and FDA granted Indoco Remedies a tentative ANDA approval for generic canagliflozin (view press release). Below, FENIX provides highlights and insights into the respective news items, including thoughts on why Medtronic’s decision to terminate the EOFlow deal makes sense.

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 2023 Investor Day Pipeline Updates; New Lilly Obesity Asset

Two cardiometabolic-related news items have been observed: Novartis hosted its 2023 R&D day (press release; webcast; slides); and Lilly initiated a Ph1 SAD/MAD study evaluating a new asset with an unknown MOA (LY3971297) in healthy participants with obesity and hypertension (view CT.gov record). Below, FENIX provides highlights and insights into 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.