Category Archives: Other

Novartis Q1 ’22 Earnings Update

Novartis hosted its Q1 ’22 earnings call (press release; slides) and provided brief updates to its CVRM business, including Entresto’s market performance and Leqvio’s commercialization. Additionally, management stated that the Sandoz strategic review remains in progress and reiterated expectations to provide an update by EOY. Below are highlights 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.

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Daprodustat NDA Accepted by FDA; Sean Saint Looks to Do It Again; April 19-22 CHMP Agenda; J&J Q1 ’22 Earnings Update

Several cardiometabolic-related news items have recently been observed: GSK announced FDA accepted the daprodustat NDA for the treatment of patients with anemia due to CKD; Sean Saint has started a new company called Luna Diabetes (view website); the CHMP agenda for this month’s meeting (April 19-22) has been released; and J&J hosted their Q1’ 22 earnings call (press release; slides). Below, FENIX provides highlights and insights for the respective new 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.

New Medtronic 780G + Lyumjev Trial; Xigduo XR DAPA-CKD sNDA approved; Galectin NASH Trial to Continue; Sciwind Initiates Ph1 Oral GLP-1RA Trial

A series of cardiometabolic-related news items have been observed: a Medtronic-sponsored study evaluating the use of Lilly’s Lyumjev in the MiniMed 780G AID system has been observed (view CT.gov record); the Xigduo XR (dapagliflozin + metformin) DAPA-CKD sNDA has recently been approved (view updated label); Galectin Therapeutics reported positive feedback from its first DSMB meeting for its Ph2b/3 NAVIGATE study evaluating belapectin in NASH (press release); and Sciwind Biosciences announced it has started dosing patients in its Ph1 MAD study evaluating the company’s investigational oral GLP-1RA (XW004; ecnoglutide) in healthy volunteers. Below, FENIX provides highlights and insights for the respective new 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.

Viatris Glargine Recalled; Carbon Health Launches Diabetes Management Program

Two cardiometabolic-related news items have been observed: Viatris announced a voluntary recall of one batch of its unbranded insulin glargine U100 10 mL vials due to a potential missing label; and Carbon Health announced the launch of its personalized diabetes management program. Below, FENIX provides highlights and insights for the respective new 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.

Apple Watch Reportedly Faces Glucose Monitoring Delays; Diabeloop to Adapt AID Software for Insulin Pens; MediciNova to Initiate Ph2 NAFLD Trial

Three cardiometabolic-related news items have been observed: It has been reported that Apple has been experiencing development problems with its blood glucose monitoring feature for its Apple Watch (view article); Diabeloop announced plans to adapt its AID software for insulin pens via a new smartphone app (DBL-4pen); and, MediciNova, Inc., announced FDA has completed its review of the company’s Ph2 clinical trial protocol to evaluate MN-001 (tipelukast) for the treatment of patients with NAFLD, T2DM, and hypertriglyceridemia. Below, FENIX provides highlights and insights for the respective new 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.

Merck Hosts Investor Event Highlighting CV Portfolio and Pipeline

Yesterday, Merck hosted an investor event (view presentation replay; view slides; view fact sheet) providing an overview of the company’s CV portfolio and pipeline. During the event, Merck highlighted eight potential new approvals across its CV pipeline, including its ongoing late-stage clinical programs in ASCVD, HF, PAH, thrombosis, and ESRD. In particular, Merck discussed its oral PCSK9i (MK-0616), currently in Ph2 development for hypercholesterolemia, as well as vericiguat (Verquvo) for symptomatic chronic HF. Below, FENIX provides highlights and insight from the call, including thoughts on Merck’s seemingly renewed focus on its CV business.

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.

AZ/Ionis Ph2b Data @ ACC 2022; Novartis Restructures Pharma Business; Eversense E3 Launched in the US; Dexcom ONE to Launch in UK; New Sota and Kerendia Subanalyses @ ACC 2022; Fractyl Receives IDE for Second Pivotal Trial

A series of cardiometabolic-related news items have been observed from AZ/Ionis, Novartis, Ascensia/Senseonics, Dexcom, Lexicon, Bayer, DiaMedica, and Fractyl. Below, FENIX provides highlights and insights for the respective new 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.

Daprodustat US approval in question after vada CRL; Akebia post-CRL investor call highlights

Following the vadadustat CRL issued on March 30, 2022, Akebia hosted a call with investors to discuss the steps forward. Below FENIX provides highlights and insights from the call, including readthrough to GSK’s daprodustat.

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 Restructures Business to Focus on R&D and Cuts 90% of US Workforce; Samsung and JDRF T1DM Invest in Jaguar Gene Therapy

Two cardiometabolic-related news items have been observed: Zealand announced a company restructuring comprised of a shift back toward an R&D organization, a CEO transition, and a 90% US workforce reduction (listen to call investor call here); and Jaguar Gene Therapy announced Samsung Ventures and the JDRF T1D Fund have invested in the company. Below, FENIX provides highlights and insights for the respective new 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.

Otsuka/Akebia receive vadadustat CRL

Akebia announced the FDA has issued a CRL regarding the vadadustat NDA for the treatment of anemia due to CKD. According to the press release, FDA concluded that the data in the NDA “do not support a favorable benefit-risk assessment of vadadustat for dialysis and non-dialysis patients.” FDA expressed safety concerns including failure to meet non-inferiority in MACE in the non-dialysis patient population, increased risk of thromboembolic events, driven by vascular access thrombosis in dialysis patients, and the risk of drug-induced liver injury. Additionally, in the CRL, FDA suggested that Akebia investigate ways to potentially demonstrate a favorable benefit-risk assessment through new clinical trials. Akebia will be working with its partners to evaluate the CRL, and it intends to request a meeting with FDA to evaluate next steps. Importantly, Akebia will host a conference call Wednesday, March 30 at 6:00 PM ET to discuss the CRL.

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.