Category Archives: Other

Akero to Initiate Ph3 NASH Program; Bigfoot Acquires Insulin Titration Algorithm; GSK Collaborates with PathAI in NASH

Three cardiometabolic-related news items have been observed: Akero Therapeutics announced it had a positive end-of-Ph2 meeting with FDA and disclosed details of the anticipated SYNCHRONY Ph3 efruxifermin (EFX) program for the treatment of NASH (view press release); Bigfoot Biomedical has acquired an insulin titration algorithm developed at McGill University (view press release); and PathAI announced it is partnering with GSK on the Ph2b HORIZON NASH trial (view CT.gov record; press release). Below, FENIX provides highlights and insights into the respective news items including thoughts on the competitive NASH therapies 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.

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FDA Releases Framework for Use of Digital Health Technology in Clinical Trials; New Ph2 Dapiglutide Obesity Trial

Two cardiometabolic-related news items have been observed: As part of FDA’s PDUFA VII commitments, the Agency published framework (view here) describing how it plans to address questions on the use of digital health technology (DHT) in clinical trials; and a Ph2 trial evaluating Zealand’s subcutaneous QW dapiglutide in obese participants with a BMI ≥ 30 kg/m² has been observed (DREAM; view CT.gov record). 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.

Viking Announces Positive Ph1 GLP-1/GIP Dual Agonist Topline Results and Initiates Oral Formulation Development; Zealand Ph1a Amylin Analog Results; Biomea Ph2 Menin Inhibitor Results

Four cardiometabolic-related news items have been observed: Viking Therapeutics announced positive topline results from the Ph1 SAD/MAD clinical trial evaluating its novel QW subcutaneous GLP-1+GIP dual agonist (VK2735; view press release) and initiated a new Ph1 study for an oral formulation of VK2735 (view press release); Zealand Pharma announced positive results from a Ph1a study of ZP8396, an amylin analog, assessing safety and PK/PD effects in healthy lean and overweight people (view CT.gov record; press release); and Biomea Fusion announced positive topline results for the first two cohorts enrolled in the Ph2 portion of its ongoing Ph1/2 COVALENT-111 study (view CT.gov record) evaluating BMF-219, a covalent menin inhibitor (view press release). 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.

Mounjaro Obesity Indication Filed in EU; March CHMP Agenda; Vertex Announces T1DM Licensing Agreement with CRISPR; Sanofi Helps Dario Secure Top-Ten PBM Contract

Three cardio-metabolic related news items have been observed: The CHMP agenda (view here) for this month’s meeting (March 27-30) has been released, which includes the new filing of the Mounjaro non-T2DM obesity indication; Vertex announced it has entered into a new non-exclusive licensing agreement with CRISPR Therapeutics for the use of CRISPR’s gene editing technology (view press release); and DarioHealth announced a new contract with an undisclosed top-ten PBM to provide Dario digital therapeutics beginning in Q2 2023 (view press release). Below, FENIX provides highlights and insights from the respective news items, including potential readthrough to the US Mounjaro obesity regulatory 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.

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.

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.

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.

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.