Tag Archives: Xeris

High-dose Trulicity, DAPA-HF and Gvoke up for Opinions; CHMP Agenda September 14-17

The CHMP agenda for this month (September 14-17) has been released, and it includes three notable items: high-dose Trulicity, Dapa-HF, Xeris’s Gvoke, as well as several other agenda items. Below, FENIX provides diabetes-related highlights and insights from the September 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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FDA Warns Xeris for Misleading Gvoke DTC

FDA’s Office of Prescription Drug Promotion (OPDP) has issued a letter to Xeris regarding misleading advertising for its Gvoke glucagon product (view OPDP letter here; view Xeris Gvoke DTC here). Below, FENIX provides an overview of OPDP’s asserted false or misleading claims as well as implications to the ongoing Gvoke launch.

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.

Ascensia Takes Over WW Eversense CGM Distribution; Xeris and Senseonics Q2 ’20 Earnings Update; Precigen ActoBio Announces Positive Topline Results for T1DM Modulator

Four diabetes-related news items have been observed: Ascensia announced a strategic partnership with Senseonics for world-wide commercialization and distribution of the Eversense implantable CGM; Senseonics hosted its Q2 ’20 earnings call (press release), Xeris hosted its Q2 ’20 earnings call (press release), and Precigen ActoBio announced positive topline results from its Ph1b study of AG019 for the treatment of early-onset T1DM. Below, FENIX provides highlights of the respective news items, including thoughts on the curious partnership between Ascensia and Senseonics in the context of the existing partnerships between Senseonics/Roche and Ascensia/POCTech.

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 Launches Gvoke HypoPen Autoinjector

Xeris announced the launch of its Gvoke HypoPen autoinjector (pictured below) for the treatment of severe hypoglycemia. The Gvoke website has also been updated, and it now includes a patient DTC video for HypoPen (view here). Below, FENIX provides thoughts on the Gvoke HypoPen launch as well as an analysis of the new DTC campaign in the context of Lilly’s Baqsimi (nasal glucagon) launch.

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 Ph2 Pramlintide+insulin Co-formulation Topline Results

Xeris Pharmaceuticals announced positive topline results from a Ph2 trial evaluating its pramlintide-insulin co-formulation (XP-3924). Xeris said it is planning for an end-of-Ph2 meeting with FDA later in 2020 to discuss the XP-3924 development path. Below, FENIX provides an overview of the topline results as well as thoughts on the market potential of XP-3924 in the context of other similar products, notably Adocia’s ADO09 (M1pram).

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.

Dapa Reduces Progression to T2DM; Teplizumab Continues to Delay T1DM Onset; Arecor AT247 Faster than Fiasp; ADA Key Press Releases (June 15)

Today, twelve diabetes-related news items were observed: DAPA-HF delays T2DM onset, teplizumab follow-up results, Arecor uRAI Ph1 data, new Afrezza practical data, Diasome HDV Ph2 results, Hua Medicine Ph3 GKA data, ORMD-0801 in NASH, Glytec CGM POC data, Biolinq’s first-in-human CGM data, and more. Below, FENIX provides context and analysis for the announcements.

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.

Medtronic Guardian Connect CGM Android Approval; Xeris PBH Ph2 Results; Capillary Biomedical Initiates Extended-wear Infusion Set Trial

Three diabetes-related news items have been observed today: Medtronic’s Guardian Connect is now compatible with Android, Xeris announced positive topline results from ready-to-use (RTU) glucagon in patients at risk of postprandial hypoglycemia following bariatric surgery, and Capillary Biomedical initiated a trial for its extended-wear infusion set. 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.

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.

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 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.

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.