Category Archives: GLP-1RA

Lilly Cuts Zepbound Prices; Cagrisema Ph3 Pediatric Obesity Trial; Ascletis Selects Obesity Candidate; Altimmune Replaces CEO; Olazarsen Breakthrough Therapy Designation; New Ph3 Bofanglutide Study; Ikaria Registers Study for Obesity Asset Monotherapy and Combination with Tirzepatide

A series of cardiometabolic-related news items has been observed from Lilly, Novo Nordisk, Ascletis Pharma, Altimmune, Ionis Pharmaceuticals, Gan & Lee Pharmaceuticals, and Ikaria Bioscience. 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 Files 7.2mg Wegovy; CMS Cuts Semaglutide Prices; FDA Publishes Marketing Violation Letters

Three cardiometabolic-related news items have been observed: Novo Nordisk submitted its sNDA to FDA for high-dose (7.2mg) Wegovy in obesity (view press release); CMS announced the negotiated prices from the second round of IRA discussions, including Novo’s semaglutide (view press release; view fact sheet); and FDA published promotional activity violation letters from the OPDP (view letters). Below, FENIX provides highlights and insights for the respective news items, including the projected approval timeline for high-dose Wegovy in the US.

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.

Novo Misses Alzheimer’s Endpoint; Merck’s New Ph1 Asset in T2DM

Two cardiometabolic-related news items have been observed: Novo Nordisk announced topline EVOKE data for sema in Alzheimer’s (view press release); and Merck registered a Ph1 study of a new undisclosed oral coformulation in T2DM (view CT.gov record). Below, FENIX provides highlights and insights for the respective news items, including potential readthrough from EVOKE to Lilly’s plans in AD.

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 and Novo Establish New Obesity Channels; Orforglipron CVOT Initiated; Lilly Ph2 Study in Chemo-Induced Nausea and Vomiting 

Three cardiometabolic-related news items have been observed: Lilly, Novo, and other partners announced direct-to-employer programs for obesity medications (view article); Lilly initiated a Ph3 CVOT for orforglipron in people with ASCVD and/or CKD (view CT.gov record); and Lilly initiated a Ph2 study of its GIP agonist for chemotherapy-induced nausea and vomiting (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.

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.

Viking Completes Ph3 Obesity Study Enrollment; FDA Clears Dexcom’s Smart Basal Feature; Modular Medical Files Patch Pump

Three cardiometabolic-related news items have been observed: Viking Therapeutics completed enrollment for its Ph3 VK2735 obesity non-T2DM study (view press release); Dexcom received FDA clearance for its Smart Basal feature (view press release) and announced plans to launch its 15 day G7 CGM in the US (view press release); and Modular Medical submitted a 510(k) for its Pivot patch pump (view press release). 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.

Medtronic CY Q3 ‘25 Earnings; Vanda Obesity Adjunct Therapy Results; Lilly Registers Another Retatrutide Ph3 Study; FDA Approves Arrowhead’s REDEMPLO in FCS

A series of cardiometabolic-related news items has been observed from Medtronic, Vanda Pharmaceuticals, Lilly, and Arrowhead Pharmaceuticals. 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.

Novo Reduces Wegovy and Ozempic US DTP Pricing

Novo Nordisk announced that effective today (November 17), it is reducing the US cash-pay price of injectable Wegovy and Ozempic to $199/month for the first two months and $349/month for subsequent months (down from $499/month). Below, FENIX provides insight into Novo’s pricing updates, including a curious observation (and hypothesis) regarding the 2.0mg Ozempic dose.

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.

Obesity CNPV Analysis: Novo Changes Strategy, but Lilly Set to Win

As part of Novo and Lilly’s recent MFN deals (previous FENIX insight), both received a Commissioner’s National Priority Voucher (CNPV), potentially accelerating the review time of a product to only 1-2 months. Novo and Lilly disclosed plans to use their CNPVs for 7.2mg semaglutide and orforglipron, respectively. Below, FENIX provides thoughts on each of the CNPVs, including why Lilly is positioned to benefit the most.

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.

Zealand to Receive PRV?; Zealand Q3 ’25 Earnings; Pfizer Completes Metsera Acquisition; WeightWatchers to Offer Oral Wegovy; Ascletis Preclinical Combination Data; MangoRx Partners with NovoCare and LillyDirect? 

A series of cardiometabolic-related news items has been observed from Pfizer/Metsera, Zealand Pharma, WeightWatchers, Ascletis Pharma, and Lilly/Mangoceuticals (MangoRx). Below, FENIX provides highlights and insights for the respective news items, including how Zealand can use a PRV to decrease the review time of petrelintide.

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 CY Q3 ’25 Earnings; Adocia Long-Acting AOM Platform Patent

Two cardiometabolic-related news items have been observed: Biocon hosted its CY Q3 ’25 (FY Q2 ’26) earnings call (press release; slides) and Adocia filed a patent for its long-acting AOM platform (view press release). 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.