Tag Archives: efsitora alfa

EASD 2024 Key Press Releases (Sep 10)

On the second day of EASD 2024, 8 key news items were observed from Lilly, Novo Nordisk, Abvance Therapeutics, Scholar Rock, Altimmune, Arrowhead Pharmaceuticals, Bayer, and Lexicon. The following topics are covered below (hyperlinks to external 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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Lilly QW Insulin QWINT-1 and -3 Topline Results; Lilly Initiates Ph3 Orforglipron Maintenance Study; Lilly-Backed OrsoBio Raises $67M in Series B for Obesity Development

Three cardiometabolic-related news items have been observed: Lilly announced positive topline results from its Ph3 QW insulin efsitora alfa trials, QWINT-1 and QWINT-3 (view press release); Lilly initiated a Ph3 study (ATTAIN-MAINTAIN; view CT.gov record) evaluating QD orforglipron in adults with overweight or obesity with weight-related comorbidities who have completed SURMOUNT-5 (tirzepatide vs. semaglutide); and OrsoBio raised $67M in a Series B financing round for the development of its mitochondrial protonophores for obesity (view article). 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

You can read the article’s full content online after purchase.

Lilly Ph3 QW Insulin Results; Roche Ph1 GLP-1/GIP RA Obesity Results; Zealand Q1 ’24 Earnings

Three cardiometabolic-related news items have been observed: Lilly announced QWINT-2 and QWINT-4 topline results, the first from its Ph3 QW insulin program (press release); Roche announced positive Ph1 CT-388 (GLP-1/GIP RA) obesity results (press release); and Zealand hosted its Q1 ’24 earnings call (press release). Below, FENIX provides highlights and insights for the respective news items, including thoughts on Lilly’s QW insulin program in the context of the impending Novo Nordisk QW icodec adcom on May 24, 2024.

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 Raises 2024 Guidance on Strong Mounjaro/Zepbound Performance; Lilly Q1 ’24 Earnings Update

Lilly hosted its Q1 ’24 earnings call (press release; slides) and provided updates across its CVRM portfolio. Of note, Lilly raised its FY revenue guidance by $2.0B to $42.4B – $43.6B, primarily due to the strong performance of Mounjaro and Zepbound. Below, FENIX provides highlights and insights from the call, including thoughts on Lilly’s strategy to develop oral formulations for tirzepatide and retatrutide.

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.

Icodec FDA Adcom Scheduled for May 2024

FDA has requested an adcom meeting on May 24, 2024, to discuss Novo Nordisk’s QW insulin icodec (view unpublished FDA document here). Recall, Novo previously disclosed FDA extended the icodec regulatory review by three months, with a decision now anticipated in Q3 2024 (previous FENIX insight). Below, FENIX provides insight on the potential implications and reasoning for an icodec adcom, including readthrough to Lilly’s QW insulin, efistora alfa.

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 and Zepbound Launch Updates; Tirzepatide Ph2 MASH Data; Lilly’s Smart Insulin Enters Ph1; Lilly Q4 ’23 Earnings Update

Lilly hosted its Q4 ’23 earnings call (press release; slides) and provided updates across its CVRM portfolio. Of note, the company announced topline tirzepatide Ph2 SYNERGY-NASH data, discussed Zepbound launch updates, provided insight into manufacturing capacity increases, and disclosed its glucose-responsive insulin has entered clinical development, among other pipeline updates. 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.

Lilly Q3 ’23 Earnings Update

Lilly hosted its Q3 ’23 earnings call (press release; slides) and provided updates across its CVRM portfolio. Management noted the 2024 guidance call will be held in January which is new as the company traditionally hosted these calls in December of the preceding year. 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.