Tag Archives: Lexicon

Lexicon Sota T1DM Indication and CKM; Lilly Expands Redwire Collaboration; 89bio Initiates Ph3 ENLIGHTEN MASH Program; Fractyl Reports Preclinical Rejuva Findings; Welldoc Receives CE Mark for Bluestar

A series of cardiometabolic-related news items have been observed from Lexicon, Lilly/Redwire, 89bio, Fractyl Health, and Welldoc. Below, FENIX provides highlights and insights for the respective news items, including thoughts on how Lexicon’s sotagliflozin T1DM indication may be linked to the future continuous ketone monitor from Abbott.

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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Lexicon Q4 ’23 Earnings; Lexicon to Resubmit Sota T1DM NDA; MannKind INHALE-3 Initial Results; Praluent Receives Pediatric HeFH FDA Approval

Four cardiometabolic-related news items have been observed from Lexicon, MannKind, and Regeneron. 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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Purchase Blast$599.00

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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.

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.

AHA 2023: Roche/Alnylam, Amgen, Amarin, Esperion, and Lexicon Present New Data; Cleerly Partner Participation in TRANSFORM HF Trial

A series of CVRM-related news items have been observed at AHA 2023 from Roche/Alnylam, Amgen, Amarin, Esperion, Lexicon, and Cleerly. 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.

Novo to Discontinue Levemir; Lilly Initiates Ph2 GLP-1/GCG RA Trial; Zealand, Lexicon, Senseonics, Xeris, and Bayer Q3 ’23 Earnings

A series of cardiometabolic-related news items have been observed from Novo Nordisk, Lilly, Zealand, Lexicon, Senseonics, Xeris, and Bayer. 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.

Sibionics Receives GS1 CGM CE Mark; Silence Therapeutics Announces Positive Ph1 Lp(a) Results; Lilly Initiates Another Oral GLP-1RA Ph3 Trial; Tandem and Amarin Q3 ‘23 Earnings; Lexicon Expands Inpefa Access; Dario Launches BGM Compatible With iPhone 15; Abbott, Insulet, and BI/Lilly Announce National Diabetes Awareness Month Initiatives

A series of cardiometabolic-related news items have been observed from Sibionics, Silence Therapeutics, Lilly, Tandem, Amarin, Lexicon, Dario, Abbott, Insulet, 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.

Novo’s FLOW Stops Early; Akero Misses in Ph2b NASH Study; Insulet Wins Preliminary Injunction Against EOFlow; Biocon Recieves Another CRL; Inpefa Receives Preferred Formulary Status with ESI; Carmot Oral GLP-1RA Ph1 Data

A series of cardiometabolic-related news items have been observed from Novo, Akero, Insulet, Biocon, Lexicon, and Carmot Therapeutics. Below, FENIX provides highlights and insights into the respective news items, including thoughts on the potential impact of Akero’s study results.

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.

Tandem, Lexicon, and Amgen Q2 ‘23 Earnings

Three cardiometabolic-related news items have been observed: Tandem Diabetes Care (view press release), Lexicon (view press release), and Amgen (press release; slides) hosted their respective Q2 ‘23 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.

Inpefa Label and Pre-launch Analysis

Following the Inpefa (sotagliflozin) approval on May 26, 2023 (view label; previous FENIX insight), FENIX has conducted an analysis of the Inpefa label and HCP website. Additionally, Lexicon hosted a post-approval investor call on May 30, 2023, where the company provided insight into its go-to-market strategy (view webcast). Of note, Lexicon plans to launch Inpefa in the US by the end of June 2023. Below, FENIX provides insights and thoughts on the Inpefa label and pre-launch activities.

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.

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.

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.