Tag Archives: Diabetes

Livongo Stock Plunges After First Post-IPO Earnings Release (Q2 ’19)

Livongo hosted its first earnings call following its July 2019 IPO. Senior management provided an overview of the company including its client and member growth prospects. Below, FENIX provides highlights and insights from the call including thoughts on why the Livongo stock plummeted following the company’s first earnings release.

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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Biocon/Mylan Glargine CRL; BI/ZEAL Dual Agonist Moves to Ph2; Vertex Acquires Semma

Three key pieces of news have recently been observed: Biocon/Mylan received a CRL from FDA regarding their bs-glargine Malaysian manufacturing facility, Boehringer Ingelheim is advancing its dual agonist into Ph2 (licensed from Zealand), and Vertex entered into a definitive agreement to acquire Semma Therapeutics. Below, FENIX provides thoughts and insights on the respective news items including the uncertainty around Biocon/Mylan’s glargine in the context of the merger with Pfizer.

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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FENIX to Host EASD Social Event on Monday Sept 16

To celebrate our new office in Barcelona, FENIX will host a social event during EASD on Monday, September 16, 2019, from 7-10pm CET. The venue is in the heart of the city at: Cheri Restaurant (Carrer d’Enric Granados, 122, Barcelona https://goo.gl/maps/r4XujW93NVifKX7MA)

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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More Thoughts from DAPA-HF… Could Novo+Lexicon Really Happen?

With the historic results of DAPA-HF recently presented at ESC 2019, FENIX provided some initial reaction. Today, FENIX continues to think about additional market possibilities and implications inside and outside SGLT2i dynamics in a winners-and-losers analysis format.

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

You can read the article’s full content online after purchase.

DAPA-HF is a Home Run, But Results Remain Unpublished

Full results from AstraZeneca’s Farxiga DAPA-HF trial were presented at ESC 2019. Data from the trial showed an impressive 26% RRR (p<0.0001) in the primary composite endpoint (CV death or worsening of heart failure) with both components contributing to the highly statistically significant result. Additionally, Novartis presented results from the Entresto PARAGON-HF trial (patients with HFpEF) which narrowly missed statistical significance on the primary endpoint but showed benefit in key subpopulations. Of note, it appears that DAPA-HF has not yet been published in any scientific journal, and the p-value in the AZ press release did not exactly match what was presented during ESC 2019. Below, FENIX provides thoughts on the DAPA-HF and PARAGON-HF results in the context of the evolving HF market.

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

You can read the article’s full content online after purchase.

DAPA-HF @ ESC 2019 on Sunday Sept 1

AstraZeneca announced that the Farxiga DAPA-HF study will be presented on Sunday, September 1, 2019 the European Society of Cardiology (ESC) congress in Paris. Of note, DAPA-HF will be presented during the same session as THEMIS (Brilinta in patients with established CAD and T2DM) and PARAGON-HF (Entresto in patients with HFpEF). On August 20, AZ announced positive topline results from the trial. FENIX will be providing an in-depth analysis of the data following the ESC presentation.

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.

AZ’s Farxiga CKD Development Receives Fast Track Designation

AstraZeneca announced FDA granted Fast Track designation to Farxiga for the prevention of renal failure and CV/renal death in patients with CKD. Recall, AZ recently announced positive topline results for DAPA-HF and subsequently purchased a priority review voucher (PRV) which FENIX believes could be used for the Farxiga HF filing. Below, FENIX provides thoughts on the Farxiga Fast Track designation in the context of Janssen’s CREDENCE FDA filing which received FDA priority review.

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

You can read the article’s full content online after purchase.

Invokana CREDENCE Filing Accepted by EMA; Dexcom Wins Patent Dispute with AgaMatrix

Last week, two key news items were observed including the Invokana CREDENCE EMA filing acceptance and resolution to the Dexcom/AgaMatrix patent dispute litigation. Below, FENIX provides context and analysis for these 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.

Lilly Wins in Arbitration with Adocia

Lilly announced that an arbitration panel ruled in favor of Lilly with regard to a claim filed by Adocia over the former partnership between the two companies. The panel decided that Lilly is not liable to pay damages. Adocia issued its own statement and held a subsequent call with investors in which it disagreed with the findings of the panel. Below, FENIX provides additional commentary from Adocia and insights into the future potential of the Adocia’s BioChaperone franchise.

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 AZ PRV Purchase and Potential Uses

AstraZeneca announced it purchased a priority review voucher (PRV) for $95M from Sobi, a subsidiary of Swedish Orphan Biovitrum AB. Below, FENIX provides thoughts on the PRV including potential scenarios for which AZ could use the PRV for either Farxiga (DAPA-HF), roxadustat (CKD anemia), or for part of its oncology franchise (trastuzumab deruxtecan), and why AZ is unlikely to use the PRV for the Epanova STRENGTH CVOT.

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.