Tag Archives: orforglipron

JPM 2026 Day 4: IVA, JNGHF, LXRX, BMEA, ESPR; FDA Delays CNPV Approvals

On the fourth and final day of JPM 2026, FENIX has provided coverage of presentations by Inventiva Pharma, Jiangsu Hengrui Pharmaceuticals, Lexicon Pharmaceuticals, Biomea Fusion, and Esperion. Separately, one CVRM-related news item has been observed: FDA has delayed CNPV approval of Tzield and orforglipron (view article). Below, FENIX provides highlights and insights from the JPM presentations as well as insight into the CNPV delays.

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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JPM 2025 Day 2: LLY, NVO, AMGN, VKTX, AZN, MRK, IONS; Obesity Association Debuts Standards of Care for Obesity Medications

On the second day of JPM 2026, FENIX has provided coverage of presentations by major CVRM companies, including Lilly, Novo Nordisk, Amgen, Viking Therapeutics, AstraZeneca, Merck, and Ionis Pharmaceuticals. Separately, one CVRM-related news item has been observed: The Obesity Association published new standards of care for obesity medications (view press release). Below, FENIX provides insights and highlights for the guidelines.

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.

Lilly’s Ph3 ATTAIN-MAINTAIN Results; Orforglipron Filed; Novo Files Cagrisema and Receives FDA Warning Letter; Merck to Receive CNPV; SAB BIO Pivotal Ph2b T1DM Trial; Sagimet Enters Agreement for Resmetirom

A series of cardiometabolic-related news items has been observed from Lilly, Novo Nordisk, Merck, SAB Biotherapeutics, and Sagimet Biosciences. Below, FENIX provides highlights and insights for the respective news items, including what Sagimet could be thinking vs. Madrigal.

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 Leadership Pushes for Expedited Orforglipron Review; Novo and Cytokinetics Positive CHMP Opinions; Rezolute Misses Endpoints in Ph3 Study

A series of cardiometabolic-related news items has been observed from Lilly, Novo Nordisk, Rezolute, and Cytokinetics. 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.

Lilly Builds New Site in Alabama; Updated ADA/EASD 2026 Diabetes Guidelines; Novo Registers New Ph1 Asset

Three cardiometabolic-related news items have been observed: Lilly announced its new Alabama manufacturing site (view press release); updated ADA/EASD 2026 diabetes SOC guidelines have been released (view guidelines; view revisions); and a new Novo Ph1 asset in T2DM has been observed (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.

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.

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.

Pfizer/Novo Battle Escalates; Lilly Registers Another ORC Study; New Lilly Orfor Manufacturing Site; GSK Ph3 MASH Program  

A series of cardiometabolic-related news items have been observed from Pfizer/Metsera, Lilly, and GSK. 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.

Lilly Q3 ‘25 Earnings; Raises FY 2025 Guidance 

Lilly hosted its Q3 ‘25 earnings call (press release; slides) and provided updates across its CVRM portfolio. Of note, the company’s stock is up 5% after raising its FY 2025 sales guidance from $60.0-62.0B to $63.0-63.5B due to strong underlying performance across its portfolio, including Zepbound and Mounjaro. 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.

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.

Beta Bionics Q3 ’25 Earnings; Lilly Partners with Walmart & Invests in Oral Manufacturing; Tandem Integrates with Libre 3+; More Novo Leadership Changes

A series of cardiometabolic-related news items have been observed from Lilly, Beta Bionics, Tandem Diabetes Care, and Novo Nordisk. 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.