Category Archives: SGLT2i

Sotagliflozin approved in US as “INPEFA”

Lexicon announced the FDA approval of sotagliflozin as “INPEFA” to reduce the risk of CV death, hospitalization for HF, and urgent HF visit in adults with HF (across the full LVEF spectrum) or T2DM, CKD, and other cardiovascular risk factors. The May 26 approval is consistent with FENIX’s projection following Lexicon’s July 2022 announcement that FDA accepted the re-submission and assigned a full 10-month review period (previous FENIX insight). The Inpefa label has not yet been observed at the time of this publication. Of note, Lexicon is hosting a call with investors on Tuesday, May 30 at 8am ET. FENIX will conduct a full label analysis of sotagliflozin in the coming days once the label is available.

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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US Supreme Court Rules in Favor of Regeneron/Sanofi Praluent Litigation

Regeneron and Sanofi announced that the US Supreme Court upheld a previous decision by the Delaware District Court and the US Court of Appeals which held that Amgen’s asserted US PCSK9 patent claims were invalid (previous FENIX insight). Of note, the unanimous Supreme Court decision ends a nearly decade-long dispute between Sanofi/Regeneron and Amgen. Below, FENIX provides brief thoughts on the ruling.

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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Farxiga DELIVER Label Analysis

Earlier this week, FDA approved Farxiga (dapagliflozin) to reduce the risk of CV death, hospitalization for HF, and urgent HF visit in adults with HF, regardless of baseline LVEF (view updated Farxiga label; previous FENIX insight). The label extension was based on positive results from the Ph3 DELIVER trial (view CT.gov record). Recall, in February 2023, Forxiga received EU approval for the expanded HF indication (previous FENIX insight). Below, FENIX has conducted a Farxiga HF label analysis in the context of the Jardiance HF indication.

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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Structure Therapeutics Advances Oral GLP-1RA to Ph2; Embecta and Tidepool Partner for T2DM Patch Pump AID Development; New SOLOIST-WHF Analysis

Three cardiometabolic-related news items have been observed: Structure Therapeutics announced it is advancing its oral GLP-1RA (GSBR-1290) into Ph2a development for T2DM and obesity (view press release); Embecta announced it has partnered with Tidepool to develop an AID system for its T2DM patch pump (view press release); and Lexicon announced results from an investigator-initiated analysis of SOLOIST-WHF which demonstrated that sotagliflozin is cost-effective at commonly accepted willingness-to-pay thresholds in patients with diabetes and worsening HF (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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AZ’s Farxiga Receives FDA Approval for DELIVER; Esperion, Xeris, Madrigal, and Sigilon Q1 ’23 Earnings; Ascensia Expands Eversense PASS Program; and Glooko Redesigns App

A series of cardiometabolic-related news items have been observed from AstraZeneca, Ascensia, and Glooko. Additionally, Esperion, Xeris, Madrigal, and Sigilon provided Q1 ’23 earnings 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

You can read the article’s full content online after purchase.

Ionis, Lexicon, and Amarin Q1 ’23 Earnings; AstraZeneca Collaborates with Sernova for Cell Therapies

Four cardiometabolic-related news items have been observed: Ionis (view press release; slides), Lexicon (view press release), and Amarin view press release; slides) hosted their respective Q1 ‘23 earnings calls and provided CVRM-related updates; and Sernova announced a preclinical research collaboration with AstraZeneca to evaluate the use of its Cell Pouch System with AstraZenaca’s therapeutic cells (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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Intercept, AZ, and Sanofi Q1 ’23 Earnings; Sanofi Completes Provention Acquisition; DRI Sells Tzield Royalties to Sanofi

Five cardiometabolic-related news items have been observed: Intercept (press release; slides), AstraZeneca (press release; slides), and Sanofi (press release; slides) hosted their respective Q1 ’23 earnings calls; Sanofi announced it has completed its acquisition of Provention Bio (view press release); and DRI Healthcare Trust announced that it has sold its Tzield royalty interests and milestone payment obligations to Sanofi for $210M (view press release). Below, FENIX provides highlights and insights 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.

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.

Lannett Announces Positive Pivotal Bs-Glargine Results; Mark Cuban’s Pharmacy Offers Janssen’s Invokana; Diamyd Partners with JDRF for Ph3 Diamyd T1DM Development

Three cardiometabolic-related news items have been observed: Lannett announced topline results from its bs-glargine U100 pivotal study (view press release; view CT.gov record); Mark Cuban Cost Plus Drug Company (view website) announced it is now offering Janssen’s Invokana, Invokamet, and Invokamet XR (view tweet); and Diamyd Medical announced it entered into a four-year research and development collaboration with JDRF to support its ongoing Ph3 DIAGNODE-3 trial in T1DM (view press release). Below, FENIX provides highlights and insights into the respective news items including potential readthrough from recent insulin price reductions announced by Lilly, Novo, and Sanofi to Lannett’s bs-glargine.

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.

CLEAR Outcomes Full Results; Abbott Libre 2 and 3 AID Clearance; New Lexicon HF Awareness Campaign; Merck to Advance Oral PCSK9i to Ph3; Amarin Announces Non-Sarissa Board Departures; BI/Lilly COORDINATE-Diabetes Results

A series of cardiometabolic-related news items have been observed from Esperion, Abbott, Lexicon, Merck, and BI/Lilly. 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.