Category Archives: Glucagon

Novo Q1 ’20 Earnings Roadshow; Xeris, Teva, and BD Earnings Updates

Novo Nordisk hosted its post-Q1 ’20 earnings roadshow event. Additionally, Xeris, Teva, and Becton Dickinson held their respective Q1 ’20 earnings calls. Teva did not discuss its generic liraglutide nor did BD discuss the status of its T2DM patch pump. Below, FENIX provides highlights and insights from the respective 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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CREDENCE and Sanofi’s Bs-Aspart up for CHMP Opinion; CHMP Agenda April 28-30

The CHMP agenda for this month’s meeting (April 28-30) has been released, and it includes two notable items up for CHMP opinion: Invokana/Vokanamet renal protection indication (CREDENCE) and Sanofi’s bs-aspart initial application. Of note, the April 2020 CHMP meeting agenda was just posted today despite the fact that the meeting started yesterday. Below, FENIX provides diabetes-related highlights and insights from the April 2020 CHMP agenda.

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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Empa T1DM Discontinued; Lilly Q1 ’20 Earnings Update; AZ Initiates Farxiga COVID-19 Trial

Lilly hosted its Q1 ’20 earnings call and provided updates to its diabetes business. Of note, Lilly disclosed that the empa T1DM program has been discontinued. Separately, AstraZeneca announced plans to evaluate Farxiga as a treatment for hospitalized COVID-19 patients who are at increased risk of complications, such as organ failure. The trial is being conducted at Saint Luke’s Mid America Heart Institute and led by Mikhail Kosiborod. Below, FENIX provides highlights and insights from the Lilly earnings call as well as thoughts on the new AZ trial.

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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Glucagon: Zealand Submits NDA for Dasiglucagon HypoPal Rescue Pen

Zealand Pharma announced it has submitted the dasiglucagon HypoPal Rescue Pen NDA for the treatment of severe hypoglycemia. Below, FENIX shares thoughts on the filing as well as the potential impact on the current glucagon rescue market including Lilly’s Baqsimi and Xeris’s Gvoke.

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.

Glooko Enables Free Remote Care Solution; Hovorka’s AP App Launched in UK; Valeritas Receives Court Approval on Zealand Sale

A series of diabetes-related news has been observed, including Glooko’s new remote patient care solution, the UK launch of Roman Hovorka’s artificial pancreas app ‘CamAPS FX’ for T1DM, and the court approval of the Valeritas sale to Zealand. 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

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Xeris Home Delivery via Amazon; Oramed End-of-Ph2 FDA Feedback

Two diabetes news items were observed today. First, Xeris made Gvoke PFS available for home delivery via Amazon Pharmacy and grounded its field force (press release). Of note, Gvoke PFS is now available for home delivery to commercially insured patients through PillPack by Amazon Pharmacy and Xeris has grounded its field force. Additionally, Oramed announced positive feedback from its oral insulin ORMD-0801 End-of-Phase2 (EoP2) CMC meeting with the FDA (press release). Below, FENIX provides highlights and thoughts surrounding these updates, including how the home delivery option could present an opportunity for Xeris and Zealand amid the COVID-19 pandemic.

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.

Zealand Q4 ’19 Earnings Update

Zealand hosted its Q4 ’19 earnings call (press release) and provided updates to its diabetes business, including dasiglucagon and other pipeline assets. Of note, Zealand indicated that the dasiglucagon HypoPal NDA is on track for submission by the end of March 2020. Below, FENIX provides highlights and thoughts surrounding these updates.

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 Q4 ’19 Earnings Update

Xeris hosted its Q4 ’19 earnings call (press release) and provided updates on its newly launched hypoglycemia rescue product Gvoke and other pipeline assets. To the best of our memory, this is believed to be the first time that Xeris hosted an earnings conference call to accompany its earnings release. Of note, Xeris also posted an updated corporate presentation from March 2020 to its IR website (presentation slides). Below, FENIX provides highlights and thoughts surrounding these updates, including how the coronavirus disruption could present an opportunity to Xeris.

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.

Positive Topline Novo QW Insulin Results; Novo Q4 ’19 Earnings Update

Novo Nordisk hosted its Q4 and FY 2019 earnings call and provided updates to its diabetes business, including a Rybelsus launch update as well as Ph2 topline results for its QW insulin LAI287 (now called insulin “icodec”). 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.

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.

Thoughts on New CVS Program to Eliminate Diabetes Drug OOP Costs

CVS Health recently announced a new program called “RxZERO,” which is said to completely eliminate all out of pocket costs (OOP) for diabetes prescription drugs. According to the press release, RxZERO will provide the benefit to members “without raising costs for the plan sponsor or increasing premiums or deductibles for all plan members.” Below, FENIX provides thoughts on the RxZERO program in the context of the ongoing drug pricing debate in the US.

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.