Tag Archives: Lilly

Teva’s Generic Saxenda Approved by FDA; Dexcom Layoffs; FDA Accepts Proposal for MASH Surrogate Endpoint; Novo Partners with Replicate for srRNA R&D; Amylyx Prioritizes its GLP-1 Antagonist Development; Lilly Pauses Mounjaro Supply and Offers Discounts in UK

A series of cardiometabolic-related news items has been observed from Teva Pharmaceuticals, Dexcom, FDA, Novo Nordisk/Replicate Bioscience, Amylyx Pharmaceuticals, and Lilly. 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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Wegovy MASH Label Analysis; Ozempic Offered Through NovoCare

FDA recently approved Wegovy (2.4mg semaglutide; QW SC GLP-1RA; view label) for the treatment of noncirrhotic MASH in adults with moderate to advanced liver fibrosis (F2-F3 MASH; view press release). The accelerated approval is based on results from Part 1 of the ongoing Ph3 ESSENCE study (view publication; previous FENIX insight). Additionally, Echosens and Novo Nordisk announced they are advancing their partnership to increase awareness and early diagnosis of MASH (view press release). Below, FENIX has conducted a Wegovy label analysis, including a comparison with Madrigal’s Rezdiffra (resmetirom), the only other approved treatment for MASH.

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 Addresses Global Drug Cost Changes; BioAge Ph1 NLRP3i Trial Update

Two cardiometabolic-related news items have been observed: Lilly published a statement about global drug cost-sharing (view here); and BioAge Labs announced it dosed the first healthy participant in its Ph1 SAD/MAD study evaluating BGE-102 (QD oral NLRP3 inhibitor; 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.

Zealand Q2 ‘25 Earnings; Lilly Raises Mounjaro Prices in UK; Lilly Partners with Superluminal for Obesity Drug Discovery 

Three cardiometabolic-related items have been observed: Zealand hosted its Q2 ‘25 earnings call (press release; slides); Lilly is reportedly increasing Mounjaro pricing in the UK to match EU pricing (view article); and Superluminal announced it entered into a drug discovery agreement with Lilly (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.

UK Partners with Lilly for Obesity Program; Altimmune and Veru Q2 ‘25 Earnings  

Three cardiometabolic-related news items have been observed: The UK government announced it has partnered with Lilly to pilot a program supporting people with obesity (view press release), Altimmune hosted its Q2 ‘25 earnings call (press release), and Veru hosted its Q2 ‘25 earnings call (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.

Lilly Leaves Door Open for Novo; Lilly Q2 ‘25 Earnings

Lilly hosted its Q2 ‘25 earnings call (press release; slides) and provided updates across its CVRM portfolio. Separately, Lilly announced topline results from its Ph3 ATTAIN-1 trial evaluating orforglipron in 3,127 non-T2DM obese adults (view press release; CT.gov record). Of note, Lilly’s stock is down -15% due to the lower-than-expected ATTAIN-1 weight loss, despite raising revenue guidance. Below, FENIX provides highlights and insights from the call and data readout.

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 SURPASS-CVOT Results; Dexcom, Sanofi, AbbVie, and Alnylam Q2 ‘25 Earnings; Novo Initiates Ph1 T1DM FGF21 Study  

A series of cardiometabolic-related news items has been observed from Lilly, Dexcom, Sanofi, AbbVie, Alnylam Pharmaceuticals, 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.

Lilly Initiates Ph2 Naperiglipron Trial; Dexcom Launches AI Meal-Tracking Feature; Trinity Announces New CGM+; Ascletis Ph2 Obesity Trial Updates

A series of cardiometabolic-related news items has been observed from Lilly, Dexcom, Trinity Biotech, and Ascletis Pharma. 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.

Sciwind GLP-1RA Licensing Rumors; Lilly Completes Verve Acquisition; Adocia Ph3 Insulin Lispro Data 

Three cardiometabolic-related news items: Sciwind is reportedly in conversations with a US pharma company interested in licensing its Ph3 obesity asset, ecnoglutide (QW SC GLP-1RA; view article); Lilly announces it completed the acquisition of Verve Therapeutics (view press release); and Adocia and Tonghua Dongbao announce Ph3 insulin lispro results in T2DM (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.

FDA Publishes Slew of CRLs in Effort to Increase Transparency

FDA announced it has published more than 200 CRLs to increase transparency. The CRLs were issued to applications submitted between 2020 and 2024, and all are for drugs that have since gained approval from the agency, a Department of Health and Human Services spokesperson told Fierce Biotech (view article). Below, FENIX provides an overview of select CRLs and brief insight into the FDA openness policy.

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.