Tag Archives: icodec

New Novo Once-Monthly Dual-Agonist; Icodec Delayed; Novo Q4 ’23 Earnings Updates

Novo Nordisk hosted its Q4 ’23 earnings call (press release; slides) and provided updates across its CVRM portfolio. The company made a number of important disclosures during the call, including a new QM GLP-1+GIP dual agonist in development, QW insulin icodec has been delayed in the US, STEP HFpEF has been filed in the US and EU, and more. Additionally, Novo reminded its 2024 CMD is being held on March 7, 2024. Of note, FENIX will also cover Novo’s London Q4 ’23 earnings call tomorrow, February 1, 2024. 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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Novo Nordisk, Tandem, Alnylam, and Regeneron Q1 ’23 Earnings

Four cardiometabolic-related news items have been observed: Novo Nordisk (view press release; slides), Tandem Diabetes Care (view press release), Alnylam Pharmaceuticals (view press release; slides), and Regeneron (view press release; slides) hosted their respective Q1 ’23 earnings calls and provided CVRM-related updates. Below, FENIX provides highlights and insights from the earnings calls.

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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Lilly Completes SURMOUNT-2 Trial; FDA Clears Libre 3 Reader; Novo Initiates Ph3 Icodec + Semaglutide Treatment Intensification Trial

Three cardiometabolic-related news items have been observed: On April 13, 2023, the ClinicalTrials.gov record for SURMOUNT-2 was updated to reflect that the trial has been completed; Abbott announced FDA cleared a standalone reader for its FreeStyle Libre 3 iCGM system (view press release); and Novo Nordisk has initiated a Ph3 T2DM trial evaluating icodec as add-on therapy to semaglutide for treatment intensification (view CT.gov record). 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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Madrigal Wins Big with Ph3 NASH Data; Novo Expands Partnership for Dose Check; AZ Announces DELIVER Positive CHMP Opinion

Three cardiometabolic-related news items have been observed: Madrigal Pharmaceuticals announced positive topline results from its Ph3 resmetirom MAESTRO-NASH study and hosted an investor call, although the company provided conflicting guidance on the filing timeline (view press release; webcast); Amalgam Rx announced the expansion of its global agreement with Novo Nordisk for the commercialization of Dose Check (view press release); and AstraZeneca announced Forxiga (dapagliflozin) received a positive CHMP opinion for DELIVER (view press release). Below, FENIX provides insights on the respective news items, including readthrough from the Madrigal data to other NASH players.

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’s QW Insulin Icodec Meets Primary Endpoint in ONWARDS 5

Novo Nordisk announced positive topline results from the final QW insulin icodec Ph3 trial (ONWARDS 5). Recall, ONWARDS 5 is differentiated from the other five trials in the ONWARDS program as it uses the DoseGuide app for titration. Below, FENIX provides thoughts on Novo’s Ph3 ONWARDS icodec program, the utility of the DoseGuide app during icodec commercialization, and the potential regulatory timeline.

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 QW Icodec Ph3 T1DM Trial Initiated; Dexcom G6 Approved for Upper Arm Wear in Canada; Dario Launches Virtual Health Initiative with MediOrbis; J&J and Abbott Q1 ’21 Earnings Updates

A series of diabetes-related news items have been observed: a CT.gov record for Novo’s Ph3 QW insulin icodec T1DM trial (ONWARDS 6) has been observed; Dexcom announced Health Canada has authorize G6 for upper arm wear; Dario announced a virtual care initiative with MediOrbis for telehealth and remote patient monitoring; Abbott hosted its Q1 ’21 earnings call; and J&J hosted its Q1 ’21 earnings call. 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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Novo/Gilead NASH PoC Data @ AASLD; Novo Q3 ’20 London Earnings Event

Novo Nordisk hosted its post-Q3 ’20 earnings event in London (see previous FENIX insight on Q3 ’20 Novo earnings from October 30). Below, FENIX provides highlights and insights from the Novo earnings call beyond what was discussed on October 30, including insight into the impending semaglutide NASH Ph3 program initiation and thoughts on the high-dose oral semaglutide approval timeline.

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 use PRV for Sema Obesity; Ph1 Glucose-responsive Insulin Trial Initiated; Novo Q3 ’20 Earnings Update

Novo Nordisk hosted its Q3 ’20 earnings call (press release; slides) and provided updates across its pipeline and commercial activities, including the ongoing Rybelus launch, positive ziltivekimab Ph2b topline results, and Ph1 initiation for a novel glucose-responsive insulin. Additionally, Novo disclosed plans to use its PRV for the semaglutide 2.4mg obesity FDA submission. Below, FENIX provides highlights and thoughts from the call, including insight into a hidden importance of using the PRV for the sema 2.4mg obesity filing.

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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New Novo QW Insulin Icodec Data; Novo Updates Rybelsus Website; Dexcom G6 VA Pharmacy Distribution; Ascensia Partners to Accelerate Data Strategy; REWIND Canada Approval; Oramed ORMD-0801 NASH Data; EASD 2020 Key Press Releases (Sept 22)

On Day 2 of EASD, five key press releases and news items were observed from Novo Nordisk, Dexcom, Ascensia, Lilly, and Oramed. Below FENIX provides insights and context from each respective announcement.

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 Discontinues its Dual/Triple Agonists for Obesity; Novo Q2 ’20 Earnings Update

Novo Nordisk hosted its Q2 ’20 earnings call (press release; slides) and provided updates to its diabetes, obesity, and NASH clinical and commercial activities, but much of the discussion was focused on Novo’s obesity portfolio. Importantly, Novo disclosed it has discontinued the development of its dual and triple agonists for the treatment of obesity following positive results from the recent semaglutide and AM833 data disclosures (semaglutide Ph3 STEP, Ph2 AM833, and Ph1 sema+AM833). Additionally, FENIX includes context from Novo’s invite-only R&D event on June 19 (view slides here). Below, FENIX provides highlights and insights from the call, including why it makes sense Novo would use its PRV for semaglutide in obesity.

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.