Category Archives: Other

Teplizumab Adcom: 10-7 Split Vote; Questions Raised on Teplizumab’s Approvability

Today, FDA held an advisory committee meeting to discuss the proposed teplizumab indication to delay the onset of T1DM based on results from the TN-10 study. The panel narrowly voted in favor (10-7) that the teplizumab benefits outweigh the risks. Recall, ahead of the adcom, FENIX correctly predicted a 10-7 vote favoring teplizumab. Below, FENIX provides a summary of key adcom panelist commentary as well as thoughts on the vote and next steps for Provention Bio and teplizumab.

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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Medtronic CY Q1 ’21 Earnings Update; FDA Accepts IND for Lilly/Dicerna Cardiometabolic Asset; Dario Digital Therapeutics Publication

Three cardiometabolic news items have been observed: Medtronic hosted its CY Q1 ’21 (FY Q4 ’21) earnings call; Dicerna announced FDA accepted Lilly’s IND application for a novel cardiometabolic asset, LY3819469, targeting the LPA gene; and Dario announced the publication of “Digital Therapeutics for Type 2 Diabetes: Incorporating Coaching Support and Validating Digital Monitoring” in Diabetes Science and Technology. 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

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

InPen and Guardian 4 Sensor Receive CE Mark; Oramed Ph3 Oral Insulin Update; Adocia Files Patents for Obesity, NASH, and T2DM

Three cardiometabolic-related news items have recently been observed: Medtronic announced it received CE Mark for expanded functionality of its InPen smart insulin pen and its Guardian 4 CGM (aka Zeus); Oramed issued a letter to shareholders in which it highlighted its Ph3 oral insulin program (press release); and Adocia announced it has filed three patent families, which include obesity, NASH, and T2DM. 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

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

Provention Bio Teplizumab Adcom Pre-read Materials Posted

FDA posted the pre-read materials for the upcoming teplizumab advisory committee meeting on May 27, 2021 at 9AM EST. Of note, it is believed this is the first time the intended marketed name for teplizumab, “Tzield,” has been disclosed. While it remains to be seen, FENIX predicts a split adcom vote (10-7 favoring teplizumab) due to questions around the clinical meaningfulness of a 2-year delay in the context of the SAEs, including immunosuppression. Below, FENIX provides a brief overview of the key points the panel will consider as well as preliminary thoughts on the adcom.

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.

Xeris to Acquire Strongbridge; NGM Bio Discontinues NASH Program; BI Selects NASH Drug Candidate From Dicerna

A series of cardiometabolic news items have been observed: Xeris and Strongbridge announced they have entered into a definitive agreement under which Xeris will acquire Strongbridge for stock and contingent value rights; NGM Bio announced the discontinuation of its NASH program following topline results from the Ph2b trial; and Dicerna announced BI has accepted a GalXC RNAi candidate, referred to as DCR-LIV2, for advancement under its existing agreement. 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.

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.

SURPASS-4 Data Continue to Impress; Arecor and Lilly Partnership

Two diabetes-related news items have been observed: Lilly announced positive topline results from the Ph3 SURPASS-4 trial comparing tirzepatide to insulin glargine in patients with T2DM and an increased CV risk; and Arecor announced it has signed a formulation study partnership with Lilly, in which Arecor will use its proprietary tech platform Arestat for “one of Lilly’s proprietary products intended for self-administration.” 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.

Roche Launches Smartphone-controlled Pump; Metronom Enters CGM JV in China; FDA Draft Guidance on T2DM Glycemic Control Devices; Dario Q1 ’21 Earnings Update; New Ascensia BGM Portal; Metacrine Ph2 NASH Trial

A series of cardiometabolic news items have been observed: Roche announced the launch of its mySugr Pump Control smartphone app; Dinova Medtech and Metronom Health have created a joint venture in China for CGM development and commercialization; FDA issued a draft guidance on medical devices intended to improve glycemic control in T2DM; Dario hosted its Q1 ’21 earnings call; Ascensia announced the launch of the new “GlucoContro.online” patient and provider portal for diabetes management and analytics; and Metacrine has enrolled the first 60 patients in its MET642 Ph2a NASH trial. 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.

Novartis Post-ACC CV Investor Event Highlights; Inclisiran Expected as Class 2 Review

Today, Novartis hosted a post-ACC cardiovascular investor event in which it provided updates across its business, including Entresto, Leqvio (inclisiran), and pelacarsen (Lp(a)). Below, FENIX provides highlights and insights from the event including thoughts on inclisiran receiving a Class 2 review.

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 Ph2 Ziltivekimab Data @ ACC 2021; Sheldon Koenig Takes Over as Esperion CEO; New T1DM Treatment from Neurodon

A series of cardiometabolic news items have been observed: full results from Novo Nordisk’s Ph2 ziltivekimab were presented at ACC 2021; Sheldon Koenig was appointed as Esperion’s new President and CEO; and Neurodon is initiating IND-enabling studies for its novel T1DM therapeutic. 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.

Senseonics, Xeris, Mannkind, and Bayer Q1 ’21 Earnings Updates

Senseonics, Xeris, Mannkind, and Bayer hosted their Q1 ’21 earnings calls and provided updates to their respective businesses. Below, FENIX provides highlights and insights from the 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.

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.