Category Archives: SGLT2i

JPM 2021 Day 4: Lexicon Poised for a Strong Comeback; Lexicon, Viatris, and Intercept @ JPM; Poxel/Metavant Partnership Terminated

On the final day of JPM 2021, FENIX has provided coverage of presentations by cardiometabolic companies including Lexicon, Viatris, and Intercept. Additionally, two separate cardiometabolic-related news items have been observed: Lexicon announced it received FDA feedback stating SOLOIST and SCORED results support a sotagliflozin NDA submission for a broad HF indication; and Poxel/Metavant announced the termination of their partnership. Below, FENIX provides a topline summary of key takeaways followed by more in-depth coverage, including Lexicon’s proposed broad HF label for sotagliflozin and Viatris’s biosimilar Toujeo.

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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CORRECTING AND REPLACING: JPM 2021 Day 1: DXCM, MDT, TDOC, NVS; FDA Accepts EMPEROR-Reduced sNDA Without Priority Review; Adocia to Develop Beta Cell Therapy for T1DM Treatment

On the first day of JPM 2021, FENIX has provided coverage of presentations by major cardiometabolic companies including Dexcom, Medtronic, Teladoc, and Novartis. Additionally, three separate cardiometabolic-related news items have been observed: BI/Lilly announced FDA has accepted the Jardiance sNDA for the reduction of HFrEF in patients with and without T2DM; Dexcom and Teladoc announced the pilot launch of the new “CGM-powered insights” feature for Livongo for Diabetes users; and Adocia filed a patent for cell therapy in patients with T1DM. Below, FENIX provides a topline summary of key takeaways by company followed by more in-depth coverage.

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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Lifescan/Sanvita Complete CGM Pilot Study; Lupin’s Generic Synjardy XR Receives Tentative FDA Approval

Two diabetes-related news items have been observed: the CT.gov record for Lifescan/Sanvita Medical’s CGM pilot study has been updated to reflect an October 2020 completion; and Lupin Limited announced it received tentative FDA approval for 5mg/1000mg, 10mg/1000mg, 12.5mg/1000mg, and 25mg/1000mg empagliflozin + metformin XR tablets. 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

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Farxiga DAPA-CKD Receives Priority Review from FDA

AstraZeneca announced FDA granted Priority Review to Farxiga for the treatment of chronic kidney disease in patients with and without T2DM based on results from the DAPA-CKD study. Recall, FDA previously granted Breakthrough Therapy designation to Farxiga for CKD in October 2020 following positive results from the DAPA-CKD trial which were first presented at ESC 2020. Of note, AZ stated the PDUFA date will occur in Q2 ’21. Below, FENIX provides a projected approval timeline for the impending DAPA-CKD regulatory review as well as readthrough to the SGLT2i class.

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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Novo Selects First Liver Therapy From Dicerna Collab; Metacrine Initiates Ph2a Jardiance Combo Trial in T2DM/NASH; Terns Pharma Raises $87M in Series C Funding; Dario Announces First Self-insured Employer Client

A series of cardiometabolic-related news items have been observed: Dicerna announced Novo Nordisk selected its first GalXC RNAi candidate for IND-enabling studies in liver-related cardiometabolic diseases; Metacrine announced the initiation of a Phase 2a combination trial of MET409 50g with empagliflozin in patients with T2DM and NASH; Terns Pharmaceuticals announced the closing of its Series C funding round with $87M raised for NASH-related trials; Dario announced an agreement with the first self-insured employer group to come from its partnership with Vitality Group. 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

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Lexicon @ Stifel; First Presentation Since SOLOIST and SCORED Results

Lexicon participated in the 2020 Stifel Virtual Healthcare Conference and provided brief updates on its sotagliflozin strategy following the data readout from SOLOIST and SCORED. In case you missed it, here is a link to FENIX’s initial thoughts on the data. Below, FENIX provides highlights from Lexicon senior management’s commentary as well as an updated perspective and implications to sotagliflozin’s commercial prospects.

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-REG OUTCOME Post Hoc Analysis; Abbott Sponsors ADA Health Equity Initiative; Nemaura Launches BEAT Platform and Updated Company Website Ahead of US proBEAT Launch

Three diabetes-related news items have been observed: BI and Lilly announced results from a post hoc analysis of the EMPA-REG OUTCOME trial; Abbott and ADA announced Abbott is the first anchor sponsor of the Health Equity Now (HEN) platform with a $5M contribution towards addressing health disparities for PWD; and Nemaura Medical announced the relaunch of its company website and the launch of its BEAT diabetes website. 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

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Lexicon Wins Big with SOLOIST and SCORED

Late yesterday, results from the sotagliflozin CVOTs (SOLOIST-WHF and SCORED) were presented at the AHA 2020 conference (view press release) and simultaneously published in the NEJM (SOLOIST-WHF publication and SCORED publication). Somewhat surprisingly, both trials demonstrated highly statistically significant CV benefits despite the fact that they were closed early due to financial and strategic reasons (previous FENIX insight). Below, FENIX provides an overview of the SOLOIST and SCORED results as well as implications to the SGLT2i class and beyond.

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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EMPEROR-Reduced Filed with EMA; November 2020 CHMP Agenda; Bayer Submits Finerenone to FDA and EMA; Xeris Q3 ’20 Earnings Update

A series of diabetes-related news items have been observed: the November 2020 CHMP agenda has been released and includes one notable item, EMPEROR-Reduced; Bayer announced it has filed finerenone for patients with CKD and T2DM with the FDA and EMA; and Xeris hosted its Q3 ’20 earnings call. Below, FENIX provides highlights and insights from the respective news items, including thoughts on the potentially curious EMPEROR-Reduced appearance on the November 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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AZ, Provention Bio, Teva, and BD Q3 ’20 Earnings Updates

AstraZeneca (press release; slides), Provention Bio (press release), Teva (press release; slides), and Becton Dickinson (press release) hosted their respective Q3 ’20 earnings calls. Below, FENIX provides diabetes-related highlights and insights from the calls, including insight into AZ’s curious move to advance the development of its PCSK9i mAb.

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.