Category Archives: GLP-1RA

CORRECTING AND REPLACING: JPM 2021 Day 1: DXCM, MDT, TDOC, NVS; FDA Accepts EMPEROR-Reduced sNDA Without Priority Review; Adocia to Develop Beta Cell Therapy for T1DM Treatment

On the first day of JPM 2021, FENIX has provided coverage of presentations by major cardiometabolic companies including Dexcom, Medtronic, Teladoc, and Novartis. Additionally, three separate cardiometabolic-related news items have been observed: BI/Lilly announced FDA has accepted the Jardiance sNDA for the reduction of HFrEF in patients with and without T2DM; Dexcom and Teladoc announced the pilot launch of the new “CGM-powered insights” feature for Livongo for Diabetes users; and Adocia filed a patent for cell therapy in patients with T1DM. Below, FENIX provides a topline summary of key takeaways by company followed by more in-depth coverage.

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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Holiday Hangover: FDA Approves First Generic Glucagon; Novo High-dose Sema EU Filing; Novo Extends COVID-19 Relief Program; Eversense Implantable CGM Delayed by FDA; Provention Bio’s Teplizumab Filing Accepted by FDA; Teplizumab July 2, 2021 PDUFA

During the holiday break, a series of diabetes-related news items were observed from Amphastar, Novo Nordisk, Senseonics, and Provention Bio. 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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Novo Files Sema 2.4mg Obesity Indication with EMA

Novo Nordisk announced it has filed the MAA for the semaglutide 2.4mg obesity indication in Europe. Recall, Novo filed sema 2.4mg for obesity with FDA on December 4, 2020. Below, FENIX provides additional insight with regard to the European obesity market.

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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Novo to Initiate Oral Sema Alzheimer’s Ph3 Program; Novo Ph3 High-dose Rybelsus Trial in 2021; Lilly to Initiate Tirzepatide HFpEF Trial; Highmark and BI Announce Jardiance OBC Results; Medtronic’s Sean Salmon Takes on CV Responsibilities; + Five Other News Items

A series of diabetes-related news items have recently been observed from Novo Nordisk, Lilly, BI/Highmark, Medtronic, Diamyd, Provention Bio, Zealand, and Sensyne Health. 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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Lilly Ph3 Tirzepatide SUPRASS-1 Data Lives up to Ph2b Hype

Lilly announced topline results from the first tirzepatide Ph3 study, SURPASS-1. The study demonstrated up to a -2.1% reduction in A1C and -9.5kg weight loss with 15mg tirzepatide, according to the trial product estimand (e.g. per-protocol analysis). Full results from the SURPASS-1 trial are scheduled to be presented at the ADA 2021 conference (June 25-29). Of note, Lilly has also recently initiated three additional Ph3 studies in the tirzepatide obesity program (SURMOUNT 2, 3, and 4). Below, FENIX provides a SURPASS-1 comparative analysis, including thoughts on tirzepatide in the context of high-dose Ozempic, high-dose Rybelsus, and high-dose Trulicity.

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.

Thoughts on Pediatric Exclusivity for Saxenda and Januvia

Two diabetes-related news items have been observed: late last week, FDA approved Saxenda for the treatment of obesity in adolescents (view press release); and FDA issued a press release stating the Januvia franchise has not been proven to improve glycemic control in pediatric patients (ages 10-17) with T2DM (view updated Januvia label). Below, FENIX provides thoughts on how the label updates are anticipated to impact the respective brands.

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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Novo Files Sema 2.4mg Obesity Indication with FDA

Novo Nordisk announced it has filed the NDA for the semaglutide 2.4mg obesity indication. Recall, Novo disclosed in October 2020 that it would be using a PRV voucher, which reduces the review to 6 months. Below, FENIX provides thoughts on the anticipated approval timeline for sema 2.4mg and readthrough to Novo’s AM833 (amylin analog) development.

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.

SUSTAIN FORTE Topline Results: Ozempic 2.0mg Doubles the Dose but not the Efficacy

Novo Nordisk announced topline results from its high-dose injectable semaglutide Ph3 study, SUSTAIN FORTE. The study demonstrated a -2.2% reduction in A1C and -6.9kg weight loss with 2.0mg semaglutide according to the trial product estimand (e.g. per-protocol analysis). Below, FENIX provides a SUSTAIN FORTE comparative analysis, including thoughts on high-dose Ozempic in the context of high-dose Rybelsus, high-dose Trulicity, and tirzepatide, as well as updated perspective on the regulatory timing for Novo’s sema obesity submission with its PRV.

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 IND for Lilly/Dicerna Cardiometabolic Asset; Gilead/Novo Announce Ph2 PoC NASH Results; Biocorp Launches Mallya in Europe; Nemaura Q3 ’20 Earnings Update; Diabeloop Partners for AID System in Japan

A series of diabetes-related news items have been observed: Dicerna announced FDA accepted Lilly’s IND application for a novel, unknown cardiometabolic asset, LY3561774; Gilead and Novo Nordisk announced positive results from a Ph2 PoC trial evaluating Novo’s semaglutide in combination with Gilead’s investigational FXR agonist and/or its ACC inhibitor for the treatment of NASH; Biocorp announced the launch of its Mallya insulin connected cap in Europe via a partnership with cgmDiabet; Nemaura Medical announced its CY Q3 ’20 (FY Q2 ’21) earnings; and Diabeloop and Terumo Corporation announced a partnership for the joint development of an AID system and exclusive distribution rights in Japan. Below, FENIX provides highlights and insight for the respective news items including curious questions on the Dicerna target split between Lilly-Novo and semaglutide Ph3 combos in NASH.

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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Novo to Acquire Emisphere Technologies; Mylan Q3 ’20 Earnings Update

Two diabetes-related news items have been observed: Emisphere Technologies announced it is being acquired by Novo Nordisk for $1.35B ($7.82/share) and Mylan announced its Q3 ’20 earnings update. Below, FENIX provides thoughts on Novo’s acquisition of Emisphere and potential catalysts behind the acquisition, including oral peptide delivery development beyond semaglutide.

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.