Tag Archives: vadadustat

JPM 2024 Day 4: MDGL, LXRX, MNKD, AKBA, and XERS; Novartis No Longer Pursuing Cytokinetics Acquisition

On the fourth and last day of JPM 2024, FENIX has provided coverage of presentations by other CVRM companies, including Madrigal, Lexicon, MannKind, and Akebia. Xeris also presented at JPM 2024 but had no meaningful discussion relating to its CVRM portfolio. Separately, one CVRM-related news item has been observed: Novartis has reportedly decided to no longer pursue a Cytokinetics acquisition (view article).

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 Accepts Vadadustat NDA Resubmission; Glooko Appoints Enrique Conterno to Board of Directors; Novo Launches “iCARE4CVD”; Todd Hobbs Joins Diasome as CMO; Teladoc Q3 ’23 Earnings

A series of cardiometabolic-related news items have been observed from Akebia, Glooko, Novo, Diasome, and Teladoc. 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.

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Novartis Discontinues Ph2 Obesity Asset; Novartis Q2 ‘23 Earnings; Akebia to Resubmit Vadadustat NDA

Two cardiometabolic-related news items have been observed: Novartis hosted its Q2 ‘23 earnings call and disclosed it is discontinuing the development MBL949 in obesity (view press release; slides); and Akebia Therapeutics announced it has completed the End of Dispute Type A meeting with FDA and plans to resubmit the vadadustat NDA for the treatment of anemia due to CKD in adult patients on dialysis in Q3 ‘23 (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.

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Purchase Blast$599.00

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Akebia Rejected Again by FDA; Know Labs Announces Positive Bio-RFID Results; Lilly and XtalPi Collaborate for AI Drug Discovery; Structure Doses First Patient in Ph2a Oral GLP-1RA Study

Four cardiometabolic-related new items have been observed: Akebia Therapeutics announced it received a written response from FDA denying the vadadustat CRL (view press release); Know Labs published a report showing the accuracy of its non-invasive Bio-RFID blood glucose reading used in combination with algorithm optimization using a light gradient-boosting machine (lightGBM) machine learning model (view press release; view report); XtalPi announced a collaboration with Lilly, using AI plus robotics to uncover first-in-class therapeutics for undisclosed targets (view press release); and Structure Therapeutics announced the first patient has been dosed in its Ph2a study evaluating GSBR-1290 in overweight/obese patients with and without T2DM (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.

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Purchase Blast$599.00

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Akebia and Viatris Q1 ’23 Earnings

Two cardiometabolic-related news items have been observed: Akebia Therapeutics (view press release) hosted its Q1 ’23 earnings call and discussed the recent approval of Vafseo (vadadustat) by the European Commission and regulatory proceedings for vadadustat in the US. Viatris (view press release; slides) also hosted its Q1 ’23 earnings call and provided brief CVRM-related updates. 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.

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Purchase Blast$599.00

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Novartis Q1 ’23 Earnings; Insulet Basal-Only T2DM Pod Receives FDA Clearance; Vadadustat Approved by EC; Sernova Announces Positive T1DM Preclinical Data with Evotec’s iPSC-Derived ILCs

Four cardiometabolic-related news items have been observed: Novartis hosted its Q1 ’23 earnings call (press release; slides); Insulet announced its basal-only T2DM pod, Omnipod GO, received FDA clearance for use in T2DM patients 18 years of age or older (view press release); Akebia Therapeutics announced the European Commission granted marketing authorization for Vafseo (vadadustat) for the treatment of symptomatic anemia associated with CKD in adults on chronic maintenance dialysis (view press release); and Sernova announced positive T1DM preclinical data for its implantable Cell Pouch device in combination with Evotec’s iPSC-derived islet-like clusters (view press release). Below, FENIX provides highlights and insight 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.

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Purchase Blast$599.00

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NeuroBo Submits NASH IND; New Akebia Vadadustat Data; Arrowhead Earns $30M Milestone Payment from GSK

Three cardiometabolic-related news items have been observed: NeuroBo Pharmaceuticals announced it has submitted an IND to FDA for a Ph2a trial of DA-1241, a novel G-protein-coupled receptor (GPR119) agonist in development for the treatment of NASH (view press release); Akebia Therapeutics announced positive topline results from the Ph3 FO2CUS trial (view CT.gov record) evaluating vadadustat in hemodialysis patients who were converted from Mircera to three times weekly oral vadadustat for the maintenance treatment of anemia due to CKD (view press release); and Arrowhead Pharmaceuticals announced that it earned a $30M milestone payment from GSK following the start of GSK’s Ph2b trial of GSK4532990 (formerly called ARO-HSD) in patients with NASH (view press release; previous FENIX insight). Below, FENIX provides highlights and insight 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.

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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.

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Purchase Blast$599.00

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Insulet and MannKind Q4 ’22 Earnings; Novo Initiates Wegovy DTC; FDA Accepts G&L’s Bs-Glargine U100 BLA; Vadadustat Receives Positive CHMP Opinion; ATTD 2023 Key Press Releases Day 3

A series of cardiometabolic-related news items have been observed from Novo Nordisk, Insulet, MannKind, Gan & Lee, Medtronic, and Akebia. 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.

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Purchase Blast$599.00

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Medtronic and Esperion CY Q4 ’22 Earnings Updates; Akebia Receives Another FDA Response for Vadadustat; Wegovy and Vadadustat CHMP Opinions; February CHMP Agenda

A series of diabetes-related news items have been observed: Medtronic (press release; slides) and Esperion (press release; slides) hosted their respective CY Q4 ’22 earnings calls; Akebia received another FDA response regarding the vadadustat CRL appeal (press release); and the February CHMP Agenda was posted, including vadadustat and Wegovy (potential) opinions. Below, FENIX provides highlights and insights from the respective news items, including thoughts on Medtronic’s Simplera CGM approval timing.

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.