Category Archives: Topics

$LXRX Trading Halted Ahead of Sotagliflozin FDA Adcom

Lexicon stock trading has been halted ahead of today’s sotagliflozin T1DM FDA adcom. The previous close was $7.70. FENIX will be providing a full analysis of 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.

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FENIX Analysis: Sotagliflozin FDA Adcom Briefing Documents

Briefing documents for the Sanofi/Lexicon sotagliflozin in T1DM FDA adcom were posted today in advance of the January 17, 2019 meeting. As anticipated, FDA’s primary concern appears to be the increased risk of DKA with sotagliflozin; however, Sanofi/Lexicon’s mitigation strategy is projected to quell the concerns of the FDA adcom voting panel. Below, FENIX provides further analysis of the briefing documents, and in light of this evidence, FENIX predicts the results of the adcom will be positive for Sanofi/Lexicon. Executive Summary The 16-member panel will be asked to respond to 4 discussion questions (sota benefits for T1DM, concern for risk of DKA, differences between……

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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JPM 2019 Day 3: Becton Dickinson

The third day of the 2019 J.P. Morgan Healthcare conference included a presentation from Becton Dickinson, which is the final diabetes-related presentation of the conference. BD senior management briefly discussed their T2DM patch pump, called Swatch, which has already been filed with FDA with a limited launch scheduled before YE 2019. Below, FENIX provides key takeaways from the BD presentation and thoughts on the future T2DM pump market including a competitor comparison table. In case you missed it, here are links to FENIX’s Day 1 and Day 2 JPM 2019 insights. Becton Dickinson In response to an analyst’s question, BD management……

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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JPM 2019 Day 2: LLY, SNY, LXRX, ABT, PODD, MYL

The second day of the 2019 J.P. Morgan Healthcare conference included diabetes-related presentations from Lilly, Sanofi, Lexicon, Mylan, Abbott, and Insulet. Separately, Lilly announced plans to further increase drug pricing transparency using Trulicity TV DTC. The commercials will include a portion directing patients to a Lilly website for more information on list price and average copays. Below, find a topline summary of key JPM takeaways by company followed by more in-depth coverage. In case you missed it, here is a link to FENIX’s Day 1 JPM 2019 insights. Lilly Lilly’s CEO provided a brief introduction to the company and referenced the……

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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JPM 2019 Day 1: DXCM, MDT, JNJ, MRK; New Bigfoot Deal with Lilly

The first day of the 2019 J.P. Morgan Healthcare conference kicked off with diabetes-related presentations from Dexcom, Medtronic, J&J, and Merck. Additionally, Bigfoot announced a non-exclusive license with Lilly for inclusion of Lilly RAI in Bigfoot’s connected care ecosystem and Ascensia entered into an agreement with POCTech for CGM distribution in 13 undisclosed geographies. Also of note, FENIX provides a brief discussion on an early stage CGM company called Glutalor which has David Simmons, former Vice President and Chief Medical Officer at Ascensia Diabetes Care, on the scientific board. Below, find a topline summary of key takeaways by company followed by more in-depth……

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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SENS: Eversense XL US Pivotal Trial and Insulin Dosing Claim sPMA

Earlier this week, Senseonics announced that the first US study participant has been implanted with the 180-day Eversense XL sensor for the pivotal PROMISE study. Additionally, Senseonics also announced they have submitted PMA supplements for an insulin dosing claim and for the removal of an MRI contraindication for the Eversense 90-day CGM system. Below, FENIX provides additional thoughts on each of these topics. Eversense XL PROMISE study details The aim of this study is to evaluate the efficacy and safety of the Eversense XL CGM in 180 diabetes patients over a 180-day period. Of note, a brief CT.gov search for Senseonics’ PROMISE study did not show any records. Recall, Eversense XL 180-day sensor is commercially available in Europe……

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 Afrezza TV DTC campaign on Jan 14, 2019

Today, MannKind hosted a business update call and provided guidance on Afrezza commercialization and their financial position. MannKind held this call as they are not presenting at the upcoming JPM healthcare conference (Jan 7-10, 2019). Of note, management indicated it has increased its consumer focus on Afrezza to drive greater uptake in 2019 by launching an Afrezza TV DTC campaign on January 14, 2019. Additionally, the company commented on CGM market penetration as a potential growth driver for Afrezza in 2019 and beyond. Below, FENIX provides diabetes-related highlights from the call. Afrezza TV DTC– On January 14, 2019, MannKind plans to launch an Afrezza TV DTC……

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.

New Medtronic IQcast Feature And Adocia RAI iLet Trial

Yesterday, Medtronic announced a hypoglycemia prediction feature called “IQcast” for the Sugar.IQ personal diabetes assistant app while Adocia announced the initiation of an AID trial evaluating BioChaperone Lispro and other RAI using the Beta Bionics’ iLet closed-loop system. Below, FENIX provides additional thoughts on each of the topics. Medtronic launches ‘IQcast’ hypo prediction feature for Sugar.IQ users According to the press release, IQcast can predict the likelihood of a hypoglycemia event anywhere between 1-4 hours in advance. This news is in-line with previous guidance from Medtronic indicating its intentions to extend the predictive alert time of Guardian Connect up to 4 hours. Of note, Medtronic denoted……

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.

New Novo Ph1 Combo Study of QW Insulin 287 + Ozempic

Last week, Novo Nordisk initiated a new Ph1 trial evaluating its QW basal insulin analog, Insulin 287, as a fixed-ratio combination with Ozempic in T2DM patients. Below, FENIX provides additional thoughts on the new Novo combo study and the potential for Lilly and Sanofi to develop next-gen fixed-ratio products in the GLP-1RA+basal insulin class. The initiation of this Ph1 trial indicates that Novo is considering developing the QW fixed-ratio GLP-1RA+basal combination. The market opportunity for a QW basal insulin seems a bit unclear due to hypo concerns; thus it may not be practical in T1DM. Presumably, as part of its franchise market forecast for the QW basal insulin, a GLP-1RA+basal fixed-ratio combo……

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.

Happy Holidays from FENIX!

This holiday season, we genuinely thank you for your readership to our FENIX news updates. In the year 2018, we successfully shared 350+ updates on the most current diabetes news with impactful market insights using our deep thought leadership. We look forward to another successful year in 2019. Have a safe and happy holiday break! Warm regards, FENIX Team :)… If you receive our email blasts, you already have an account. Log in nowContext counts when making decisions.Purchase Blast$599.00You can read the article’s full content online after purchase. About The Author Matthew Maryniak | President of Fenix Group International Matthew…

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.