Category Archives: Topics

89bio Positive Ph2b Pegozafermin NASH Data; Novartis Discontinues Inclisiran UK Primary Prevention Trial; Novo Nordisk Partners with Dewpoint Therapeutics; Evkeeza Receives Pediatric Approval

A series of cardiometabolic-related news items have been observed from 89bio, Novartis, Dewpoint Therapeutics, and Regeneron. 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.

Altimmune Ph2 Obesity and Ph1b T2DM Pemvidutide Data

Altimmune announced topline results from a Week 24 interim analysis of pemvidutide (QW GLP-1/GCG dual agonist) in its 48-week MOMENTUM Ph2 obesity trial (view CT.gov record) along with full results from the 12-week Ph1b safety trial in subjects with obesity or overweight and T2DM (view CT.gov record). The company hosted an associated investor call to discuss the results (webcast; slides). Of note, Altimmune stated it is on track to initiate a Ph3 obesity trial in H1 2023. Following the news, Altimmune’s stock price decreased approximately -54%. Below, FENIX provides highlights and insights, including thoughts on whether Altimmune will be able to differentiate pemvidutide from semaglutide, tirzepatide, and other dual agonists in development.

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.

Senseonics Q4 ’22 Earnings and CGM Investor Event; OrsoBio Doses First Patient in Ph2 TLC-3595 Trial for Insulin Resistance

Two cardiometabolic-related news items have been observed: Senseonics hosted a CGM virtual investor event last week which coincided with the company’s Q4 2022 earnings release (press release; slides); and OrsoBio announced that the first patient has been dosed in its Ph2a clinical trial evaluating the safety and insulin sensitizing effects of TLC-3595, a selective ACC2 inhibitor (view press release; CT.gov record). Below, FENIX provides highlights and insights from the news items, including thoughts on Senseonics’s pipeline in the context of its previous commercial struggles and the evolving CGM landscape.

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.

Sanofi Follows Lilly and Novo’s Insulin Price Cuts

Sanofi announced it will cut the Lantus WAC price by 78% and cap the monthly out-of-pocket cost at $35 for commercially insured patients. Additionally, Sanofi will cut the WAC price of Apidra by 70%. The move follows similar insulin price cuts by Lilly (previous FENIX insight) and Novo Nordisk (previous FENIX insight). According to the press release, the price decreases will take effect on January 1, 2024. Below, FENIX provides an updated insulin pricing analysis.

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.

Nemaura Includes Insulin in EU DuoPack License Agreement; Sigilon Q4 ‘22 Earnings

Two CVRM-related news items have been observed: Neumara announced the inclusion of insulin on the list of eligible drugs for its EU DuoPack License Agreement; and Sigilon issued their Q4 ‘22 earnings and disclosed plans to advance its SIG-002 program into the IND-enabling stage (press release). Below, FENIX provides highlights and insights from the 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 Nordisk to Lower US Insulin Prices

Novo Nordisk announced plans to lower prices for its pre-filled insulin pens and vials by 65-75% starting January 1, 2024. The news follows a similar move recently made by Lilly to cap most of its US insulin costs at $35/month (previous FENIX insight). Below, FENIX provides highlights and insights into Novo’s insulin price cuts, including an updated RAI and basal insulin pricing analysis.

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.

Sanofi Acquires Provention Bio; Ozempic Takes Stage at Oscars

Two CVRM-related news items have been observed: Sanofi and Provention have entered a $2.9B acquisition deal (press release); and Ozempic takes center stage at the 2022 Oscar awards show (view article). Below, FENIX provides highlights and insights from the news items, including thoughts on how the Provention Bio acquisition fits into Sanofi’s diabetes strategy.

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 TV DTC Analysis; Intercept OCA Adcom Set

Lilly has launched its first Mounjaro TV DTC with an ad called “What If” (view here). Additionally, Intercept announced FDA formally set an adcom date on May 19, 2023 regarding the ongoing obeticholic acid NDA review for the treatment of NASH. Below, FENIX provides an analysis of the Mounjaro DTC commercial, including thoughts on the timing of the DTC initiation.

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.

Vertex Announces FDA Clearance of IND for VX-264 in T1DM; Akebia and Dario Q4 ’22 Earnings

Three cardiometabolic-related news items have been observed: Vertex announced FDA has cleared the VX-264 IND application for the treatment of T1DM (press release); and Akebia Therapeutics (press release) and Dario Health (press release) hosted their respective Q4 ’22 earnings calls. 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.

FDA Accepts Jardiance Pediatric sNDA; New Teplizumab Pediatric Trial; Sernova Completes Islet Transplantation in First Two Ph1/2 T1DM Patients; Xeris and vTv Therapeutics Q4 ’22 Earnings

A series of cardiometabolic-related news items have been observed: BI/Lilly announced FDA accepted the Jardiance (empagliflozin) pediatric T2DM sNDA (view press release); Provention Bio initiated a Ph4 open-label trial evaluating the safety and PK of teplizumab in participants with Stage 2 T1DM who are <8 years of age (PETITE-T1D; view CT.gov record); Sernova announced the first two patients in the second cohort of its US Ph1/2 clinical trial received their first islet transplant (view press release); and Xeris (press release) and vTv Therapeutics (press release) released their Q4 ’22 earnings. Below, FENIX provides highlights and insights from 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.