AstraZeneca hosted its Q4 ’19 and FY ’19 earnings call and provided updates to its diabetes business. Of note, AZ disclosed it received Fast Track designation for the development of cotadutide (dual GLP-1/GCG agonist) for the treatment of NASH. Below, FENIX provides highlights and insights from the call.
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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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Dexcom hosted its Q4 ’19 and FY ’19 earnings call and provided updates to its CGM business. Of note, Dexcom has continued to show significant revenue growth, reaching total topline sales of nearly $1.5B in 2019 (+43% YOY). Below, FENIX provides highlights and insights from the earnings call including a Dexcom comment on Lilly’s smartpen launch.
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You can read the article’s full content online after purchase.
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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Insulet announced it has initiated a “voluntary Medical Device Correction” for all Omnipod DASH devices. According to Insulet, on some rare occasions when the bolus calculator is left open or an alarm interrupts a bolus calculation, DASH may suggest incorrect boluses based on older glucose values. Below, FENIX provides thoughts on the Omnipod DASH issue in the context of Medtronic’s recent 630G/670G pump recall as well as potential readthrough to Tandem, Bigfoot, and Beta Bionics.
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You can read the article’s full content online after purchase.
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’s medical device recalls website has been updated with a new recall alert regarding the Medtronic 600 series pump platform (630G and 670G products). According to the FDA website, the recall is based on a faulty or missing retainer ring which helps lock the insulin cartridge into place. Medtronic is said to have received over 26k complaints about the defect with at least 2,175 injuries and 1 patient death. Below, FENIX provides thoughts on the Medtronic insulin pump recall including insight as to why Tandem may be the big winner.
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You can read the article’s full content online after purchase.
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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It is being reported by Bloomberg that a series of Sanofi executives are leaving the company as “part of the broader effort to shake up Sanofi.” The four execs are said to include Dieter Weinand (EVP Primary Care), Ameet Nathwani (EVP, CMO, and Chief Digital Officer), Kathleen Tregoning (EVP External Affairs), and Dominique Carouge (EVP Business Transformation). Sanofi is anticipated to issue a press release regarding the departures later today. Below, FENIX provides brief thoughts on the continued changes in Sanofi senior leadership.
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Senseonics announced a new partnership with Companion Medical to integrate Eversense implantable CGM data into the Companion Medical InPen platform. Additionally, Nemaura Medical issued a press release for its FY Q3 ’19 (CY Q4 ’19) earnings. Below, FENIX provides thoughts on the partnership including why it makes sense for both Senseonics and Companion Medical.
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You can read the article’s full content online after purchase.
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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A series of diabetes-related news has been observed including an announcement that Zealand intends to acquire Valeritas’s assets (manufacturer of the V-Go insulin delivery device) as well as positive topline results from the vTv Therapeutics Ph2 Simplici-T1 study of TTP399, a novel glucokinase activator. Zealand and vTv hosted calls with investors to discuss their respective news items. Below, FENIX provides highlights and insights including thoughts on how vTv may have a difficult time finding a TTP399 Ph3 partner given the ongoing SGLT2i T1DM regulatory situation.
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You can read the article’s full content online after purchase.
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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A CT.gov record has been observed for a new Novo Nordisk Ph1 trial evaluating the co-administration of subcutaneous semaglutide and a novel, unidentified compound (NNC0480-0389). Below, FENIX provides an overview of the trial as well as insights as to why NNC0480-0389 is believed to be a GIP agonist.
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You can read the article’s full content online after purchase.
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 hosted its post-Q4 ’19 earnings event in London. Furthermore, Sanofi and Becton Dickinson held their respective Q4 ’19 earnings calls. Below, FENIX provides highlights and insights from the earnings calls including Sanofi’s plans to divest its interest in efpeglenatide as well as thoughts on how Novo’s QW basal insulin icodec could have broader implications to the hybrid closed-loop market.
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You can read the article’s full content online after purchase.
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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A new CT.gov record for Lilly’s tirzepatide CVOT (SURPASS CVOT) has been observed. The trial details are consistent with Lilly’s discussion during its recent Q4 ’19 earnings call. Below, FENIX provides an overview and brief thoughts on the SURPASS CVOT study.
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You can read the article’s full content online after purchase.
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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