Category Archives: Topics

Lilly Hosts 2021 Investment Community Meeting

Lilly hosted its 2021 Investment Community Meeting (view presentation replay; view diabetes/obesity slides). During the event, Lilly highlighted a new strategy to expand its focus beyond diabetes to include obesity-related diseases (e.g. CV, liver, and kidney) by leveraging tirzepatide’s best-in-class profile. As part of the update, Lilly also provided an overview of the Ph3 QW insulin program as well as an overview of its early CVRM pipeline assets. 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.

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Sigilon Announces Strategic Reprioritization; Jaguar Gene Therapy Includes T1DM in Initial Pipeline Program

Two cardiometabolic-related news items have been observed: Sigilon Therapeutics announced plans for a strategic reprioritization to focus on its MPS-1 and beta cell therapy for T1DM, including a 38% workforce reduction; and Jaguar Gene Therapy announced target genes for its initial pipeline programs in T1DM, autism, and T1 Galactosemia. 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

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December 13-16 CHMP Agenda; Novo Invests Further in Kalundborg Manufacturing Facilities; CytoDyn Reports Additional Data from Ph2 Leronlimab NASH Trial; Adocia Files Patent for Oral Delivery Technology of Peptides

A series of cardiometabolic-related news items have been observed: the CHMP agenda for this month’s meeting (December 13-16) has been released, and Bayer’s finerenone is up for an opinion; Novo Nordisk announced an investment of DKK 17B (~$2.6B USD) into expanding its manufacturing facilities in Kalundborg, Denmark; CytoDyn announced additional preliminary results to date from the 20 patients who have completed the Ph2 open-label trial evaluating the impact of leronlimab on liver fibrosis associated with NASH; and Adocia announced it has filed a patent for an oral delivery technology. 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.

Lilly Partners with Regor Therapeutics for Metabolic Drug Discovery

Lilly announced it has entered into a multi-year research agreement with Regor Therapeutics Group for the discovery, development, and commercialization of novel therapies for metabolic disorders. For context, Regor Therapeutics Group (view website) is a Chinese-based pharma company using Computer Accelerated Rational Discovery (CARD) to develop new medicines. Interestingly, the press release states, “Regor’s technology will also allow Lilly to further accelerate innovation and deliver breakthrough therapies in obesity and diabetes,” suggesting the partnership is broader than obesity and diabetes. Below, FENIX provides thoughts and insights on the Regor partnership.

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.

Ionis Hosts 2022 Investor Day; Intercept Withdraws OCA MAA in NASH

A series of cardiometabolic-related news items have been observed: Ionis hosted its 2022 Investor Day (view slides), and Intercept announced it has withdrawn the obeticholic acid (OCA) Marketing Authorization Application for the treatment of fibrosis due to NASH. 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.

vTv Therapeutics to Reduce Workforce by 65%; Innovent Announces Positive Results for Ph1 GLP-1/GCG from Lilly; Nemaura Completes Initial Shipment of CGM Devices to MySugarWatch DuoPack Limited

Three cardiometabolic-related news items have been observed: vTv Therapeutics announced restructuring plans in order to prioritize its Ph3 TTP399 program, including a workforce reduction of 65%; Innovent Biologics announced that results from its Ph1b clinical trial of IBI362 (LY3305677), a dual GLP-1/GCG receptor agonist, for T2DM were presented at the 2021 IDF conference; and Nemaura announced it has completed its initial shipment of sugarBEAT CGM to its UK licensing partner MySugarWatch Limited. 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.

Tandem Hosts 2021 R&D Webinar; FDA Accepts IND for G&L’s Novel GLP-1 Analogue; BD Announces Name of Diabetes Spin Off Company

Three cardiometabolic-related news items have been observed: Tandem hosted its 2021 R&D webinar (view here; slides) and provided an in-depth review of the company’s product pipeline, including the t:slim X3, t:sport (Mobi), and a future patch pump; Gan & Lee announced FDA accepted its IND application for a novel GLP-1 analog, referred to as GZR18; and Becton Dickinson announced that its diabetes spinoff business company will be named “embecta [pronounced em-BECK-tah]. 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.

Abbott Sues Dexcom Over Breached Settlement Agreement; Bigfoot Clinical Hub Improvements; Hygieia Raises $17M in Series B; ViaCyte’s Ph1/2 VC-02 Preliminary Results Published; Dario Announces New Employer and Provider Contracts

A series of cardiometabolic-related news items have been observed: Abbott recently filed a lawsuit stating Dexcom allegedly violated a 2014 settlement agreement and asked the court to declare that Abbott doesn’t infringe its patents (view article); Bigfoot Biomedical issued a press release highlighting the success of its Bigfoot Unity Diabetes Management Program and Clinic Hub; Hygieia announced it has raised $17M in Series B financing for its AI-driven d-Nav insulin dose automation technology; ViaCyte announced preliminary results of its ongoing, first-in-human Ph1/2 VC-02 trial were published in Cell Stem Cell and Cell Reports Medicine; and Dario announced new employer and provider contracts. 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.

Novartis Hosts 2021 R&D Webinar

Novartis hosted its 2021 R&D webinar (view here; slides) and provided a company-wide outlook through 2030 with regard to its cardio-renal pipeline, management focused on Leqvio (PCSK9i for ASCVD), pelacarsen (Lp(a) for ASCVD), and iptacopan (Factor B Complement for nephrology and hematology). There was only brief commentary regarding Entresto’s continued growth. Below, FENIX provides highlights and insights from the Novartis R&D event.

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.

Sciwind Biosciences Acquires Worldwide Rights to Sanofi’s GIP Receptor Agonists; Diamyd Pauses Initiation of Ph3 DIAGNODE-3 Trial; AMF Medical’s Sigi Patch Pump Receives Breakthrough Device Designation; FDA Authorizes Sample Size Expansion for Fractyl Health’s Revitalize-1 Pivotal Trial

A series of cardiometabolic-related news items have been observed: Sciwind Biosciences announced it has entered into a WW exclusive licensing agreement to develop and commercialize Sanofi’s GIP receptor agonists; Diamyd Medical announced it has paused the initiation of its Ph3 DIAGNODE-3 trial due to potential contamination in the manufacturing process of the Diamyd diabetes vaccine; AMF Medical announced that its insulin patch pump for closed-loop integration (Sigi) has received Breakthrough Device Designation; and Fractyl Health announced FDA authorized the expansion of its Revitalize-1 pivotal clinical study (formerly REVITA-T2Di) sample size from 288 to 420. 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.