Tag Archives: semaglutide

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.

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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.

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Purchase Blast$599.00

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Lilly Invests in Early-Stage Glucose-Responsive Insulin Company; Novo Presents Full STEP 3 Results; Lifescan Hires New Head of Marketing; New CymaBay GPR119 Hypo Prevention Trial

A series of diabetes-related news items have been observed: Lilly invests in Protomer Technologies, a company developing novel drug therapies, including glucose-responsive insulin (view press release); Novo presents full data from the STEP 3 semaglutide obesity study at the 2020 Obesity Week conference (view press release); Lifescan hires Lisa Rose as the new Chief Marketing Officer (view press release); and CymaBay announced its GPR119 agonist will be evaluated in a T1DM hypo prevention study at Richard Pratley’s Translational Research Institute (view press release). 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.

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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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New Semaglutide HFpEF Trial (STEP HFpEF); DAPA-MI Posted on CT.gov; Final Day of EASD 2020 (Sept 25)

On the final day of EASD 2020, no new press releases were observed; however, during the Novo Nordisk obesity session, the speaker disclosed plans to conduct a semaglutide HFpEF study. Additionally, AstraZeneca’s DAPA-MI study has been posted on CT.gov. Below, FENIX provides insights and context from the respective news items, including thoughts on why the STEP HFpEF trial appears to fit into the new paradigm of non-outcomes-based label-enabling studies.

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.

New Oral Sema High-Dose and Flexible Administration Ph1 Trials from Novo

Two new Ph1 trials for Novo Nordisk’s oral semaglutide have been observed on CT.gov. The first Ph1 trial (NCT04524832) is evaluating high-dose oral semaglutide (25mg and 50mg), and the second study (NCT04513704) is comparing flexible administration schedules in terms of the required food restriction. Below, FENIX provides an overview of both trials as well as insight into why each of the trials clearly fit into Novo’s strategy for its GLP-1RA franchise.

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.

Novo Q2 ’20 Roadshow; Provention Bio Q2 ’20 Earnings Update; Senseonics Eversense Covered by Highmark

Novo Nordisk hosted its post-Q2 ’20 earnings roadshow event (see previous FENIX insight on Q2 ’20 Novo earnings from August 6). Additionally, Provention Bio hosted its Q2 ’20 earnings call yesterday (press release), and Senseonics announced a positive coverage decision for its implantable CGM from Highmark. Below, FENIX provides highlights and insights from the respective news item and 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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Purchase Blast$599.00

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Novo Reports Impressive AM833 Ph2 and AM833+sema Ph1 Topline Results

Novo Nordisk announced positive topline results for its Ph2 AM833 and Ph1 AM833+semaglutide trials, both for the treatment of obesity. Novo previously disclosed AM833 has been given the INN of “cagrilintide.” Recall, on June 12, 2020, Novo reported topline results from the final two trials in its Ph3 semaglutide obesity program (previous FENIX insight). Below, FENIX provides an overview of the topline data as well as brief thoughts on AM833 in the context of Novo’s injectable semaglutide Ph3 obesity program.

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.

Novo Reports Final Sema Obesity Ph3 Topline Data; Jim Malone Joins Bigfoot; ADA 2020 Key Press Releases (June 12)

Today, two diabetes-related news items were observed: Novo reported topline results from the final semaglutide obesity Ph3a trials (STEP 2 and 3) and Bigfoot appointed Jim Malone as the company’s new CMO. Recall, Malone previously served as a Senior Medical Director for Lilly where he was responsible for the global development of Lilly insulin products and insulin delivery devices, including connected care. Below, FENIX provides context and analysis for the announcements. Medtronic-related coverage will be provided in a separate blast after their investor 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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Purchase Blast$599.00

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

Semaglutide Ph3 Obesity Positive Topline Results (STEP 4)

Yesterday, Novo Nordisk announced positive results from the Ph3a STEP 4 trial evaluating the safety and efficacy of Semaglutide 2.4mg on body weight. Recall, STEP 4 is the first of the Ph3 semaglutide obesity program trials to read out. Below, FENIX provides an overview of the results as well as thoughts on potential readthrough to high-dose Ozempic.

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.