Tag Archives: roxadustat

Abbott and Dexcom Ads Observed; Madrigal, Esperion, Mannkind, Viatris Q4 ’23 Earnings; AZ Terminates Rights to Roxadustat

A series of cardiometabolic-related news items have been observed from Abbott/Dexcom, Madrigal, Esperion, Mannkind, Viatris, and AstraZeneca/FibroGen. 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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Wegovy Label Update; Jardiance Receives EMPA-KIDNEY Approval in EU; Glucotrack Announces Positive Implantable CGM Data; Thane Wettig Succeeds Enrique Conterno as Fibrogen CEO

Four cardiometabolic-related news items have been observed: The Wegovy US label has been updated to include 1.7mg as a second maintenance dose in addition to the 2.4mg dose (view label); BI/Lilly announced the European Commission (EC) approved Jardiance for the treatment of adults with CKD (view press release); Glucotrack announced positive results from the feasibility study for its implantable CGM (view press release); and Fibrogen announced the resignation of Enrique Conterno, with Thane Wettig taking over as interim CEO (view press release). Below, FENIX provides highlights and insights on the respective news items, including insight into Novo’s potential rationale for adding another Wegovy maintenance dose.

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.

Roxa Adcom Votes Overwhelmingly Against Approval in NDD (1-13) and DD (2-12)

Today, FDA held an advisory committee meeting to discuss the proposed roxadustat indication for the treatment of anemia due to CKD in non-dialysis dependent (NDD) and dialysis-dependent (DD) adults. The panel voted 1-13 and 2-12 against either NDD or DD approval, respectively. Below, FENIX provides a summary of key adcom panelist commentary as well as thoughts on the vote and next steps for AZ/Fibrogen and Akebia/Otsuka’s vadadustat.

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.

Roxa Adcom Docs Released: FDA Mixed on Risk-Benefit

Today, FDA released the briefing documents for the July 15 roxadustat advisory committee. Overall, the documents have a mixed tone, making the outcome unclear for the two voting questions posed to the 15 voting panelists. Below, FENIX provides highlights and insights from the documents, including a prediction that the adcom vote will be split while still favoring Fibrogen/AZ due to the composition of the adcom panel.

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.

Roxadustat Adcom May Be Impacted By Roster Changes

Ahead of the AstraZeneca/Fibrogen roxadustat FDA adcom on July 15, 2021, FENIX has identified a recent event that may be impactful to the overall result. More specifically, the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) roster has been updated with three committee member terms ending and two new members being added. Below, FENIX provides thoughts on how the updated roster could favor/disfavor AZ/Fibrogen.

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.

Roxa Data Hiccup Embarrassing But Not Catastrophic

Yesterday, Fibrogen issued a press release and hosted a call with investors in which the company provided clarification on certain prior disclosures of US primary CV safety analyses from the roxadustat Ph3 program for the treatment of CKD anemia. According to the press release, while senior management was preparing for the roxadustat adcom (tentatively scheduled for July 15, 2021), it became clear that the “primary cardiovascular safety analyses included post-hoc changes to the stratification factors.” Below, FENIX provides thoughts from various angles that suggest the ~40% share price hit to Fibrogen is a non-contextualized Wall Street overreaction.

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.

Enrique Conterno’s Retirement Doesn’t Last Long

Fibrogen announced it has appointed Enrique Conterno as its new CEO. Recall, during Lilly’s Q3 ’19 earnings call, the company announced that Conterno would retire at the end of 2019 to be succeeded by Mike Mason. Below, FENIX provides brief thoughts on Conterno’s new role as the head of Fibrogen.

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.